ID

37821

Description

ICHOM Atrial Fibrillation data collection Version 1.0.0 Published: 3rd April 2019 International Consortium for Health Outcomes Measurement (ICHOM), Source: http://www.ichom.org/ The following conditions and treatment approaches (or interventions) are covered by our Standard Set. Conditions: Atrial Fibrillation Population: An adult (≥ 18 years) diagnosed with atrial fibrillation (including symptomatic patients) Treatment approaches: Management of cardiovascular risk factors and institution of preventive therapy | Pharmacological management| Non-Pharmacological management Excluded populations: Children and Young persons below 18 years Excluded conditions: Patients diagnosed with cardiotoxic acute atrial fibrillation This document contains the Ongoing – Clinical Form. It has to be filled in ongoing after 6 months and annually. Collecting Patient-Reported Outcome Measure: PROMIS Global Health. As there is an official distribution site, the questions of this questionnaire will not be included in this version of the standard set. For more information see: https://bit.ly/29aOZu9 Montreal Cognitive Assessment Test. For more information see: https://www.mocatest.org/ The Standard set of ICHOM was supported by the BigData@Heart organization.

Link

http://www.ichom.org/

Keywords

Versions (3)
  1. 8/22/19 8/22/19 -
  2. 8/26/19 8/26/19 - Sarah Riepenhausen
  3. 4/30/20 4/30/20 - Sarah Riepenhausen
Copyright Holder

ICHOM

Uploaded on

August 26, 2019

DOI

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License

Creative Commons BY-NC 3.0
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ICHOM Atrial Fibrillation

English

Ongoing - Clinical Form

1 forms  
Administrative Data
Description

Administrative Data

Alias
UMLS CUI-1
C1320722
Indicate the patient's medical record number
Description

This number will not be shared with ICHOM. In the case patient-level data is submitted to ICHOM for benchmarking or research purposes, a separate ICHOM Patient Identifier will be created and cross-linking between the ICHOM Patient Identifier and the medical record number will only be known at the treating institution INCLUSION CRITERIA: All patients TIMING: On all forms REPORTING SOURCE: Administrative or clinical RESPONSE OPTIONS: According to institution

Data type

integer

Alias
UMLS CUI [1]
C1269815
Time Relative to Baseline
Description

This Item does not exist in the original standard set, instead it is asked to do the following: Please timestamp all variables. Some Standard Set variables are collected at multiple timepoints, and we will ask you to submit these variables in a concatenated VARIABLEID_TIMESTAMP form for future analyses. For example, VARIABLEID_AT (After treatment); VARIABLEID_AS (After surgery); VARIABLEID_UPDATE (Update at least annually), etc.

Data type

text

Alias
UMLS CUI [1,1]
C0439564
UMLS CUI [1,2]
C1442488
Long-term consequences of disease
Description

Long-term consequences of disease

Alias
UMLS CUI-1
C0443252
UMLS CUI-2
C0686907
UMLS CUI-3
C0012634
Indicate if the patient has died
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0011065
Indicate the date of death
Description

Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative date Type: Date by DD/MM/YYYY Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C1148348
DD/MM/YYYY
Tick if Date of death unknown
Description

Note: This item does not exist in the original version of the standard set. Please tick if you do not know the date of death. Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative date

Data type

boolean

Alias
UMLS CUI [1,1]
C1148348
UMLS CUI [1,2]
C0439673
Indicate cause of cardiovascular death
Description

Inclusion Criteria: If ‘1 = Yes’ to DEATH Timing: Ongoing Data Source: Administrative data Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0007465
Indicate whether there was a cardiovascular event
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C1320716
Indicate the type of cardiovascular event that occurred
Description

Inclusion Criteria: If ‘1 = Yes’ to CARDIOVASCULAREVENT Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0332307
Provide the date of which the Cardiovascular event occurred
Description

Inclusion Criteria: If ‘1, 2, or 3’ to EVENTTYPE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C1320716
UMLS CUI [1,2]
C0011008
DD/MM/YYYY
Indicate if a new clinical diagnosis of heart failure has been made in this patient
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205314
UMLS CUI [1,3]
C0332140
Provide the date of Heart failure diagnosis
Description

Inclusion Criteria: If ‘1 = Yes’ to HF Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0018801
UMLS CUI [1,3]
C0205314
UMLS CUI [1,4]
C0332140
DD/MM/YYYY
Indicate if left ventricular ejection fraction (LVEF) was measured
Description

Inclusion Criteria: If ‘1 = Yes’ to HF Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1]
C0428772
Provide date of LVEF measurement
Description

Inclusion Criteria: If ‘1 = Yes’ to LVEF Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0428772
DD/MM/YYYY
Provide a value of LVEF measurement
Description

Inclusion Criteria: If ‘1 = Yes’ to LVEF Timing: Ongoing Data Source: Clinical Type: Numerical value Response Options: LVEF measurement value

Data type

integer

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0242485
Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
Description

Supporting Definition: * admission = at least one overnight stay at a hospital or acute care facility from first atrial fibrillation diagnosis **Cardiovascular causes for admission are ones in which the principal admitting diagnosis relates to the cardiovascular system: myocardial infarction / ischaemic heart disease, heart failure, stroke/TIA, peripheral arterial disease, AF, venous thromboembolism/PE, etc. Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0184666
UMLS CUI [1,2]
C0038454
Indicate type of cardiovascular cause
Description

Inclusion Criteria: If ‘1 = Yes’ to CVHOSPADM Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0332307
UMLS CUI [1,2]
C0184666
UMLS CUI [1,3]
C0038454
UMLS CUI [1,4]
C0085978
Was a fast atrial arrhythmia detected?
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0456962
Provide the date when fast atrial arrhythmia was detected
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0011008
DD/MM/YYYY
Indicate type of treatment
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0085611
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0087111
If the patient received the treatment, indicate the type of monitoring performed post-treatment
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0456962
UMLS CUI [1,2]
C0085611
UMLS CUI [1,3]
C0150496
UMLS CUI [1,4]
C2709088
Provide the date when each treatment started to be monitored
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0808070
UMLS CUI [1,2]
C2709088
UMLS CUI [1,3]
C0030695
UMLS CUI [1,4]
C0456962
UMLS CUI [1,5]
C0004238
DD/MM/YYYY
Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
Description

Inclusion Criteria: If ‘1 = Yes’ to FAA Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1298908
UMLS CUI [1,2]
C0456962
UMLS CUI [1,3]
C0085611
UMLS CUI [1,4]
C2709088
UMLS CUI [1,5]
C0030695
Complications of treatment
Description

Complications of treatment

Alias
UMLS CUI-1
C0087111
UMLS CUI-2
C0009566
Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
Description

Inclusion Criteria: If ‘1 = Yes’ to CVEVENT Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0038454
UMLS CUI [1,2]
C0333275
Please provide date of Haemorrhagic stroke
Description

Inclusion Criteria: If ‘1 = Yes’ to HSTROKE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0038454
UMLS CUI [1,3]
C0333275
DD/MM/YYYY
Indicate whether the patient had fatal bleeding
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1302234
UMLS CUI [1,2]
C0019080
Provide date of fatal bleeding event
Description

Inclusion Criteria: If ‘1 = Yes’ to FBLEED Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1302234
UMLS CUI [1,3]
C0019080
DD/MM/YYYY
Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0231220
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C1511545
UMLS CUI [1,4]
C0205146
UMLS CUI [2,1]
C0231220
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0178784
Provide date of symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
Description

Inclusion Criteria: If ‘1 = Yes’ to CRITICALBLEED Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C0019080
UMLS CUI [1,4]
C1511545
UMLS CUI [1,5]
C0205146
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0231220
UMLS CUI [2,3]
C0019080
UMLS CUI [2,4]
C0178784
DD/MM/YYYY
Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
Description

Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C0019080
UMLS CUI [1,2]
C0678227
UMLS CUI [1,3]
C0547047
UMLS CUI [1,4]
C0019046
UMLS CUI [2,1]
C0019080
UMLS CUI [2,2]
C0678227
UMLS CUI [2,3]
C0686904
UMLS CUI [2,4]
C1879316
Provide date of when patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
Description

Inclusion Criteria: If ‘1 = Yes’ to BLEEDOUTCOME Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C0019080
UMLS CUI [1,3]
C0678227
UMLS CUI [1,4]
C0547047
UMLS CUI [1,5]
C0019046
UMLS CUI [2,1]
C0011008
UMLS CUI [2,2]
C0019080
UMLS CUI [2,3]
C0678227
UMLS CUI [2,4]
C0686904
UMLS CUI [2,5]
C1879316
DD/MM/YYYY
Procedure
Description

Procedure

Alias
UMLS CUI-1
C0087111
Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
Description

Additional comment (not in the original standard set): Please fill in this item repeatedly if more than one procedure and provide a date for each of these procedures in a new PROCEDUREDATE item. Inclusion Criteria: All patients Timing: Ongoing Data Source: Clinical Type: Single or multiple answers

Data type

text

Alias
UMLS CUI [1]
C0455713
Provide date of the procedure
Description

Inclusion Criteria: If ‘1-8’ to PROCEDURE Timing: Ongoing Data Source: Clinical Type: Single answer Response Options: DD/MM/YYYY

Data type

date

Measurement units
  • DD/MM/YYYY
Alias
UMLS CUI [1]
C2584899
DD/MM/YYYY
SAE
Description

SAE

Alias
UMLS CUI-1
C1519255
Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
Description

Inclusion Criteria: If ‘1-8’ to PROCEDURE Timing: Ongoing Data Source: Clinical Type: Single answer

Data type

integer

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0184661
Please specify serious adverse event(s)
Description

Additional comment (not in the original standard set): Please fill in this item repeatedly if more than one serious adverse event due to procedure and provide a date for each event in a new SAEDATE item. Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Single/multiple answers

Data type

text

Alias
UMLS CUI [1,1]
C1519255
UMLS CUI [1,2]
C0332282
UMLS CUI [1,3]
C0087111
Other SAE due to procedure, specification
Description

Note: This item does not exist in the original standard set. It can be filled in for specification if you ticked the item "SAE_10". Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Free text

Data type

text

Alias
UMLS CUI [1,1]
C0205394
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0184661
UMLS CUI [1,5]
C2348235
Provide date(s) of serious adverse events due to procedure
Description

Inclusion Criteria: If ‘1 = Yes’ to PROCEDURESAE Timing: Ongoing Data Source: Clinical Type: Date(s) Response Options: DD/MM/YYYY(s)

Data type

date

Measurement units
  • DD/MM/YYYY(s)
Alias
UMLS CUI [1,1]
C0011008
UMLS CUI [1,2]
C1519255
UMLS CUI [1,3]
C0332282
UMLS CUI [1,4]
C0184661
DD/MM/YYYY(s)
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Similar models

Ongoing - Clinical Form

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
Administrative Data
C1320722 (UMLS CUI-1)
Patient ID
Item
Indicate the patient's medical record number
integer
C1269815 (UMLS CUI [1])
Time Relative to Baseline
Item
Time Relative to Baseline
text
C0439564 (UMLS CUI [1,1])
C1442488 (UMLS CUI [1,2])
Item Group
Long-term consequences of disease
C0443252 (UMLS CUI-1)
C0686907 (UMLS CUI-2)
C0012634 (UMLS CUI-3)
Item
Indicate if the patient has died
integer
C0011065 (UMLS CUI [1])
Anticoagulation therapy
Code List
Indicate if the patient has died
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of death
Item
Indicate the date of death
date
C1148348 (UMLS CUI [1])
Date of death unknown
Item
Tick if Date of death unknown
boolean
C1148348 (UMLS CUI [1,1])
C0439673 (UMLS CUI [1,2])
Item
Indicate cause of cardiovascular death
integer
C0007465 (UMLS CUI [1])
Cause of death
Code List
Indicate cause of cardiovascular death
CL Item
an acute myocardial infarction (1)
C0155626 (UMLS CUI-1)
(Comment:en)
CL Item
sudden cardiac death (2)
C0085298 (UMLS CUI-1)
(Comment:en)
CL Item
heart failure (3)
C0018801 (UMLS CUI-1)
(Comment:en)
CL Item
stroke (4)
C0038454 (UMLS CUI-1)
(Comment:en)
CL Item
cardiovascular procedure (5)
C0189573 (UMLS CUI-1)
(Comment:en)
CL Item
cardiovascular haemorrhage (6)
C0007222 (UMLS CUI-1)
C0019080 (UMLS CUI-2)
(Comment:en)
CL Item
other cardiovascular causes e.g. peripheral arterial disease (7)
C0007465 (UMLS CUI-1)
C0205394 (UMLS CUI-2)
C0007222 (UMLS CUI-3)
C1704436 (UMLS CUI-4)
(Comment:en)
CL Item
Non-cardiovascular death (8)
C0007465 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
C0007222 (UMLS CUI-3)
(Comment:en)
CL Item
Unknown (999)
C0439673 (UMLS CUI-1)
(Comment:en)
Item
Indicate whether there was a cardiovascular event
integer
C1320716 (UMLS CUI [1])
Anticoagulation therapy
Code List
Indicate whether there was a cardiovascular event
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item
Indicate the type of cardiovascular event that occurred
integer
C0038454 (UMLS CUI [1,1])
C0332307 (UMLS CUI [1,2])
Ischaemic stroke
Code List
Indicate the type of cardiovascular event that occurred
CL Item
an ischaemic stroke (1)
C0948008 (UMLS CUI-1)
(Comment:en)
CL Item
a systemic embolism (2)
C0013922 (UMLS CUI-1)
C0205373 (UMLS CUI-2)
(Comment:en)
CL Item
an unclassified stroke (3)
C0038454 (UMLS CUI-1)
C1298908 (UMLS CUI-2)
C0008902 (UMLS CUI-3)
(Comment:en)
CL Item
none of above (4)
C0151453 (UMLS CUI-1)
(Comment:en)
Date of Cardiovascular event
Item
Provide the date of which the Cardiovascular event occurred
date
C1320716 (UMLS CUI [1,1])
C0011008 (UMLS CUI [1,2])
Item
Indicate if a new clinical diagnosis of heart failure has been made in this patient
integer
C0018801 (UMLS CUI [1,1])
C0205314 (UMLS CUI [1,2])
C0332140 (UMLS CUI [1,3])
Anticoagulation therapy
Code List
Indicate if a new clinical diagnosis of heart failure has been made in this patient
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of a new heart failure diagnosis
Item
Provide the date of Heart failure diagnosis
date
C0011008 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])
C0205314 (UMLS CUI [1,3])
C0332140 (UMLS CUI [1,4])
Item
Indicate if left ventricular ejection fraction (LVEF) was measured
integer
C0428772 (UMLS CUI [1])
Anticoagulation therapy
Code List
Indicate if left ventricular ejection fraction (LVEF) was measured
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of Left ventricular ejection fraction
Item
Provide date of LVEF measurement
date
C0011008 (UMLS CUI [1,1])
C0428772 (UMLS CUI [1,2])
Value of LVEF measurement
Item
Provide a value of LVEF measurement
integer
C0428772 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
Item
Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
integer
C0184666 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
Anticoagulation therapy
Code List
Indicate if the patient was admitted* due to an unplanned cardiovascular cause**
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item
Indicate type of cardiovascular cause
integer
C0332307 (UMLS CUI [1,1])
C0184666 (UMLS CUI [1,2])
C0038454 (UMLS CUI [1,3])
C0085978 (UMLS CUI [1,4])
Type of cardiovascular cause hospital admission
Code List
Indicate type of cardiovascular cause
CL Item
myocardial infarction / ischaemic heart disease (1)
C0027051 (UMLS CUI-1)
C1869045 (UMLS CUI-2)
(Comment:en)
CL Item
heart failure (2)
C0018801 (UMLS CUI-1)
(Comment:en)
CL Item
stroke/TIA (3)
C3844446 (UMLS CUI-1)
(Comment:en)
CL Item
peripheral arterial disease (4)
C1704436 (UMLS CUI-1)
(Comment:en)
CL Item
venous thromboembolism/PE (5)
C1861172 (UMLS CUI-1)
(Comment:en)
CL Item
atrial fibrillation (6)
C0004238 (UMLS CUI-1)
(Comment:en)
CL Item
other cardiovascular cause (7)
C0205394 (UMLS CUI-1)
C0007226 (UMLS CUI-2)
C0085978 (UMLS CUI-3)
(Comment:en)
Item
Was a fast atrial arrhythmia detected?
integer
C0085611 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
Anticoagulation therapy
Code List
Was a fast atrial arrhythmia detected?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of fast atrial arrhythmia detection
Item
Provide the date when fast atrial arrhythmia was detected
date
C0085611 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0011008 (UMLS CUI [1,3])
Item
Indicate type of treatment
integer
C0085611 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Type of treatment
Code List
Indicate type of treatment
CL Item
Rate control drugs (1)
C0489879 (UMLS CUI-1)
C0013227 (UMLS CUI-2)
(Comment:en)
CL Item
Pharmacological cardioversion (2)
C1963873 (UMLS CUI-1)
(Comment:en)
CL Item
Electrical cardioversion (3)
C0013778 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial ablation (4)
C2825182 (UMLS CUI-1)
(Comment:en)
CL Item
AVN/His bundle ablation (5)
C3275044 (UMLS CUI-1)
C2007105 (UMLS CUI-2)
(Comment:en)
CL Item
Surgical atrial ablation (6)
C0547070 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
(Comment:en)
CL Item
Pacemaker (7)
C0030163 (UMLS CUI-1)
(Comment:en)
CL Item
Other (8)
C0205394 (UMLS CUI-1)
(Comment:en)
Item
If the patient received the treatment, indicate the type of monitoring performed post-treatment
integer
C0456962 (UMLS CUI [1,1])
C0085611 (UMLS CUI [1,2])
C0150496 (UMLS CUI [1,3])
C2709088 (UMLS CUI [1,4])
Fast atrial arrhythmia post treatment monitoring
Code List
If the patient received the treatment, indicate the type of monitoring performed post-treatment
CL Item
12-lead ECG (1)
C0430456 (UMLS CUI-1)
(Comment:en)
CL Item
Ambulatory monitoring (2)
C0439841 (UMLS CUI-1)
C0030695 (UMLS CUI-2)
(Comment:en)
CL Item
Implantable devices (3)
C0687659 (UMLS CUI-1)
(Comment:en)
CL Item
Wearable devices/smartphones (4)
C4505348 (UMLS CUI-1)
(Comment:en)
Date when each treatment started to be monitored
Item
Provide the date when each treatment started to be monitored
date
C0808070 (UMLS CUI [1,1])
C2709088 (UMLS CUI [1,2])
C0030695 (UMLS CUI [1,3])
C0456962 (UMLS CUI [1,4])
C0004238 (UMLS CUI [1,5])
Item
Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
integer
C1298908 (UMLS CUI [1,1])
C0456962 (UMLS CUI [1,2])
C0085611 (UMLS CUI [1,3])
C2709088 (UMLS CUI [1,4])
C0030695 (UMLS CUI [1,5])
Anticoagulation therapy
Code List
Was the patient free from fast atrial arrhythmia at the time of the post-treatment monitoring (i.e. in sinus rhythm or rate-controlled atrial fibrillation)?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item Group
Complications of treatment
C0087111 (UMLS CUI-1)
C0009566 (UMLS CUI-2)
Item
Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
integer
C0038454 (UMLS CUI [1,1])
C0333275 (UMLS CUI [1,2])
Anticoagulation therapy
Code List
Indicate whether cardiovascular event was proven to be a haemorrhagic stroke
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of haemorrhagic stroke
Item
Please provide date of Haemorrhagic stroke
date
C0011008 (UMLS CUI [1,1])
C0038454 (UMLS CUI [1,2])
C0333275 (UMLS CUI [1,3])
Item
Indicate whether the patient had fatal bleeding
integer
C1302234 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
Anticoagulation therapy
Code List
Indicate whether the patient had fatal bleeding
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of fatal bleeding
Item
Provide date of fatal bleeding event
date
C0011008 (UMLS CUI [1,1])
C1302234 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
Item
Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
integer
C0231220 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C1511545 (UMLS CUI [1,3])
C0205146 (UMLS CUI [1,4])
C0231220 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0178784 (UMLS CUI [2,3])
Anticoagulation therapy
Code List
Indicate whether the patient had symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of symptomatic bleeding in a critical area or organ
Item
Provide date of symptomatic bleeding in a critical area or organ e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular, or pericardial, or intramuscular with compartment syndrome
date
C0011008 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C0019080 (UMLS CUI [1,3])
C1511545 (UMLS CUI [1,4])
C0205146 (UMLS CUI [1,5])
C0011008 (UMLS CUI [2,1])
C0231220 (UMLS CUI [2,2])
C0019080 (UMLS CUI [2,3])
C0178784 (UMLS CUI [2,4])
Item
Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
integer
C0019080 (UMLS CUI [1,1])
C0678227 (UMLS CUI [1,2])
C0547047 (UMLS CUI [1,3])
C0019046 (UMLS CUI [1,4])
C0019080 (UMLS CUI [2,1])
C0678227 (UMLS CUI [2,2])
C0686904 (UMLS CUI [2,3])
C1879316 (UMLS CUI [2,4])
Anticoagulation therapy
Code List
Indicate whether the patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Date of when bleeding caused a fall in haemoglobin or transfusion
Item
Provide date of when patient had bleeding causing a fall in haemoglobin > 2g/dL or transfusion of > 2 units of whole blood/red cells
date
C0011008 (UMLS CUI [1,1])
C0019080 (UMLS CUI [1,2])
C0678227 (UMLS CUI [1,3])
C0547047 (UMLS CUI [1,4])
C0019046 (UMLS CUI [1,5])
C0011008 (UMLS CUI [2,1])
C0019080 (UMLS CUI [2,2])
C0678227 (UMLS CUI [2,3])
C0686904 (UMLS CUI [2,4])
C1879316 (UMLS CUI [2,5])
Item Group
Procedure
C0087111 (UMLS CUI-1)
Item
Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
text
C0455713 (UMLS CUI [1])
Procedures
Code List
Did the patient receive one of the listed procedures? (choose the one that applies, note the patient could have several procedures)
CL Item
Catheter-based ablation (1)
C2702800 (UMLS CUI-1)
(Comment:en)
CL Item
Pulmonary vein isolation (1a)
C3544330 (UMLS CUI-1)
(Comment:en)
CL Item
Complex left atrial catheter ablation (1b)
C2702800 (UMLS CUI-1)
C0443246 (UMLS CUI-2)
(Comment:en)
CL Item
AV node ablation (1c)
C3275044 (UMLS CUI-1)
(Comment:en)
CL Item
Atrial flutter ablation (1d)
C2702801 (UMLS CUI-1)
(Comment:en)
CL Item
Surgical ablation procedure (including all types of maze procedures) (2)
C0547070 (UMLS CUI-1)
C0543467 (UMLS CUI-2)
C0397414 (UMLS CUI-3)
(Comment:en)
CL Item
Hybrid surgical-catheter ablation (3)
C0004238 (UMLS CUI-1)
C0009429 (UMLS CUI-2)
C0547070 (UMLS CUI-3)
C0543467 (UMLS CUI-4)
C0397414 (UMLS CUI-5)
C2702800 (UMLS CUI-6)
(Comment:en)
CL Item
Left atrial appendage closure/occlusion (device) (4)
C0004238 (UMLS CUI-1)
C0205091 (UMLS CUI-2)
C4523927 (UMLS CUI-3)
C0004238 (UMLS CUI-5)
C0205091 (UMLS CUI-6)
C0441597 (UMLS CUI-7)
(Comment:en)
CL Item
Left atrial appendage ligation/excision (surgical) (5)
C0004238 (UMLS CUI-1)
C0225860 (UMLS CUI-2)
C0598782 (UMLS CUI-3)
C0023690 (UMLS CUI-4)
C0004238 (UMLS CUI-5)
C0225860 (UMLS CUI-6)
C0598782 (UMLS CUI-7)
C0543467 (UMLS CUI-8)
C0728940 (UMLS CUI-9)
(Comment:en)
CL Item
Electrical cardioversion (6)
C0004238 (UMLS CUI-1)
C0013778 (UMLS CUI-2)
(Comment:en)
CL Item
Pacemaker implantation (7)
C0189842 (UMLS CUI-1)
(Comment:en)
CL Item
Pharmacological cardioversion (8)
C0004238 (UMLS CUI-1)
C1963873 (UMLS CUI-2)
(Comment:en)
CL Item
No, patient didn’t receive any of listed procedures (9)
C0087111 (UMLS CUI-1)
C4489286 (UMLS CUI-2)
(Comment:en)
Date of the procedure
Item
Provide date of the procedure
date
C2584899 (UMLS CUI [1])
Item Group
SAE
C1519255 (UMLS CUI-1)
Item
Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
integer
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
Anticoagulation therapy
Code List
Did the patient experience serious adverse event(s) due to the procedure within 90 days of follow-up?
CL Item
No (0)
C1298908 (UMLS CUI-1)
(Comment:en)
CL Item
Yes (1)
C1705108 (UMLS CUI-1)
(Comment:en)
Item
Please specify serious adverse event(s)
text
C1519255 (UMLS CUI [1,1])
C0332282 (UMLS CUI [1,2])
C0087111 (UMLS CUI [1,3])
Serious adverse event due to procedure
Code List
Please specify serious adverse event(s)
CL Item
In hospital death (1)
C0277608 (UMLS CUI-1)
(Comment:en)
CL Item
Vascular complications (2)
C1393529 (UMLS CUI-1)
(Comment:en)
CL Item
Postoperative haemorrhage (2a)
C0032788 (UMLS CUI-1)
(Comment:en)
CL Item
Postoperative haemorrhage requiring transfusion (2b)
C0032788 (UMLS CUI-1)
C1514873 (UMLS CUI-2)
C1879316 (UMLS CUI-3)
(Comment:en)
CL Item
Vascular complications (2c)
C1393529 (UMLS CUI-1)
(Comment:en)
CL Item
Pericardial tamponade (2d)
C0007177 (UMLS CUI-1)
(Comment:en)
CL Item
Requiring open heart surgery (3)
C1514873 (UMLS CUI-1)
C0189745 (UMLS CUI-2)
(Comment:en)
CL Item
Requiring repeat ablation procedure (4)
C1514873 (UMLS CUI-1)
C0205341 (UMLS CUI-2)
C0162563 (UMLS CUI-3)
(Comment:en)
CL Item
Ventricular arrhythmias (5)
C0085612 (UMLS CUI-1)
(Comment:en)
CL Item
Respiratory complications (6)
C0035237 (UMLS CUI-1)
C0009566 (UMLS CUI-2)
(Comment:en)
CL Item
Pneumothorax (6a)
C0032326 (UMLS CUI-1)
(Comment:en)
CL Item
Phrenic nerve palsy (6b)
C0238371 (UMLS CUI-1)
(Comment:en)
CL Item
Pulmonary vein stenosis (6c)
C0340756 (UMLS CUI-1)
(Comment:en)
CL Item
Other iatrogenic respiratory complications (6d)
C0205394 (UMLS CUI-1)
C0439669 (UMLS CUI-2)
C0035237 (UMLS CUI-3)
C0009566 (UMLS CUI-4)
(Comment:en)
CL Item
Trauma embolic complications, stroke, TIA, systemic or pulmonary embolism (7)
C3714660 (UMLS CUI-1)
C0013922 (UMLS CUI-2)
C0009566 (UMLS CUI-3)
C0038454 (UMLS CUI-5)
C0007787 (UMLS CUI-7)
C0205373 (UMLS CUI-9)
C0013922 (UMLS CUI-10)
C0034065 (UMLS CUI-12)
(Comment:en)
CL Item
Postprocedure infections (8)
C3714514 (UMLS CUI-1)
(Comment:en)
CL Item
Atrio-esophageal fistula (9)
C3854460 (UMLS CUI-1)
(Comment:en)
CL Item
Other (specify) (10)
C0205394 (UMLS CUI-1)
(Comment:en)
Other SAE due to procedure, specification
Item
Other SAE due to procedure, specification
text
C0205394 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
C2348235 (UMLS CUI [1,5])
Date(s) of Serious adverse events due to procedure
Item
Provide date(s) of serious adverse events due to procedure
date
C0011008 (UMLS CUI [1,1])
C1519255 (UMLS CUI [1,2])
C0332282 (UMLS CUI [1,3])
C0184661 (UMLS CUI [1,4])
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