ID

39911

Description

ARB and CCB Longest Combination Treatment on Ambulatory and Home BP in Hypertension With Atrial Fibrillation -Multicenter Study on Time of Dosing (ACROBAT); ODM derived from: https://clinicaltrials.gov/show/NCT01748253

Link

https://clinicaltrials.gov/show/NCT01748253

Keywords

Versions (1)
  1. 3/3/20 3/3/20 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

March 3, 2020

DOI

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License

Creative Commons BY 4.0
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Eligibility Hypertension and Atrial Fibrillation NCT01748253

English

Eligibility Hypertension and Atrial Fibrillation NCT01748253

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. hypertensive patients who meet the following conditions:
Description

Hypertensive

Data type

boolean

Alias
UMLS CUI [1]
C0857121
patients who meet any of the following standards of blood pressure after administration of 40 mg/day telmisartan or 5 mg/day amlodipine for 4 weeks:
Description

Standard Blood pressure Fulfill | Status post Telmisartan U/day | Status post Amlodipine U/day

Data type

boolean

Alias
UMLS CUI [1,1]
C1442989
UMLS CUI [1,2]
C1271104
UMLS CUI [1,3]
C1550543
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C0248719
UMLS CUI [2,3]
C0456683
UMLS CUI [3,1]
C0231290
UMLS CUI [3,2]
C0051696
UMLS CUI [3,3]
C0456683
blood pressure at hospital visit: systolic blood pressure is 140 mmhg or higher, and/or diastolic blood pressure is 90 mmhg or higher.
Description

Blood pressure Hospital visit | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1271104
UMLS CUI [1,2]
C0545092
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
(average of 3 measurements obtained at a scheduled visit)
Description

Average Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1265611
blood pressure at home: systolic blood pressure is 135 mmhg or higher, and/or diastolic blood pressure is 85 mmhg or higher.
Description

Blood pressure At home | Systolic Pressure | Diastolic blood pressure

Data type

boolean

Alias
UMLS CUI [1,1]
C1271104
UMLS CUI [1,2]
C4534363
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
(average of measurements for the 5 days prior to drug assignment [4 measurements per day in total: 2 in the morning and 2 before bedtime])
Description

Average Measurement Quantity

Data type

boolean

Alias
UMLS CUI [1,1]
C1510992
UMLS CUI [1,2]
C0242485
UMLS CUI [1,3]
C1265611
2. patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
Description

Atrial Fibrillation by ECG Finding

Data type

boolean

Alias
UMLS CUI [1]
C0344434
3. age: 20 years old or older (at time of informed consent)
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
4. sex: male or female
Description

Gender

Data type

boolean

Alias
UMLS CUI [1]
C0079399
5. clinical classification: outpatient
Description

Outpatients

Data type

boolean

Alias
UMLS CUI [1]
C0029921
6. patients who give written consent of agreement to voluntarily participate in the clinical study.
Description

Informed Consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. patients with serious liver and/or kidney disease
Description

Liver disease Serious | Kidney Disease Serious

Data type

boolean

Alias
UMLS CUI [1,1]
C0023895
UMLS CUI [1,2]
C0205404
UMLS CUI [2,1]
C0022658
UMLS CUI [2,2]
C0205404
2. patients with history of allergy to telmisartan or amlodipine
Description

Hypersensitivity Telmisartan | Amlodipine allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0248719
UMLS CUI [2]
C0570921
3. patients receiving antihypertensives other than telmisartan or amlodipine during observation period
Description

Antihypertensive Agents | Exception Telmisartan | Exception Amlodipine

Data type

boolean

Alias
UMLS CUI [1]
C0003364
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0248719
UMLS CUI [3,1]
C1705847
UMLS CUI [3,2]
C0051696
4. patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
Description

Persistent atrial fibrillation | Chronic atrial fibrillation | Permanent atrial fibrillation

Data type

boolean

Alias
UMLS CUI [1]
C2585653
UMLS CUI [2]
C0694539
UMLS CUI [3]
C2586056
5. patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
Description

Atrial Fibrillation caused by Illness | Cardiac Surgery procedures | Pulmonary Embolism | Hyperthyroidism

Data type

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0015127
UMLS CUI [1,3]
C0221423
UMLS CUI [2]
C0018821
UMLS CUI [3]
C0034065
UMLS CUI [4]
C0020550
6. patients with average systolic blood pressure at hospital visit higher than 180 mmhg during observation period.
Description

Average systolic blood pressure Hospital visit

Data type

boolean

Alias
UMLS CUI [1,1]
C1282151
UMLS CUI [1,2]
C0545092
7. patients with new york heart association (nyha) class iii-iv heart failure, patients with heart failure requiring hospitalization, or patients with poor left ventricular function.
Description

Heart failure New York Heart Association Classification | Heart failure Hospitalization Required | Impaired left ventricular function

Data type

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1708385
UMLS CUI [3]
C0242698
8. patients who have stroke or cardiac infarction within 6 months before giving consent.
Description

Cerebrovascular accident | Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0038454
UMLS CUI [2]
C0027051
9. patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including pci).
Description

Ablation Surgery Pulmonary artery Planned | Operative Surgical Procedure Any Planned | Percutaneous Coronary Intervention Planned

Data type

boolean

Alias
UMLS CUI [1,1]
C0547070
UMLS CUI [1,2]
C0543467
UMLS CUI [1,3]
C0034052
UMLS CUI [1,4]
C1301732
UMLS CUI [2,1]
C0543467
UMLS CUI [2,2]
C1552551
UMLS CUI [2,3]
C1301732
UMLS CUI [3,1]
C1532338
UMLS CUI [3,2]
C1301732
10. patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
Description

Breast Feeding | Pregnancy | Possible pregnancy | Pregnancy, Planned

Data type

boolean

Alias
UMLS CUI [1]
C0006147
UMLS CUI [2]
C0032961
UMLS CUI [3]
C0425965
UMLS CUI [4]
C0032992
11. in addition, patients who are determined as not eligible by their study doctor.
Description

Patients Ineligible Physician Decision

Data type

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1512714
UMLS CUI [1,3]
C1709536
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Similar models

Eligibility Hypertension and Atrial Fibrillation NCT01748253

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Hypertensive
Item
1. hypertensive patients who meet the following conditions:
boolean
C0857121 (UMLS CUI [1])
Standard Blood pressure Fulfill | Status post Telmisartan U/day | Status post Amlodipine U/day
Item
patients who meet any of the following standards of blood pressure after administration of 40 mg/day telmisartan or 5 mg/day amlodipine for 4 weeks:
boolean
C1442989 (UMLS CUI [1,1])
C1271104 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])
C0231290 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C0456683 (UMLS CUI [2,3])
C0231290 (UMLS CUI [3,1])
C0051696 (UMLS CUI [3,2])
C0456683 (UMLS CUI [3,3])
Blood pressure Hospital visit | Systolic Pressure | Diastolic blood pressure
Item
blood pressure at hospital visit: systolic blood pressure is 140 mmhg or higher, and/or diastolic blood pressure is 90 mmhg or higher.
boolean
C1271104 (UMLS CUI [1,1])
C0545092 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Average Measurement Quantity
Item
(average of 3 measurements obtained at a scheduled visit)
boolean
C1510992 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Blood pressure At home | Systolic Pressure | Diastolic blood pressure
Item
blood pressure at home: systolic blood pressure is 135 mmhg or higher, and/or diastolic blood pressure is 85 mmhg or higher.
boolean
C1271104 (UMLS CUI [1,1])
C4534363 (UMLS CUI [1,2])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
Average Measurement Quantity
Item
(average of measurements for the 5 days prior to drug assignment [4 measurements per day in total: 2 in the morning and 2 before bedtime])
boolean
C1510992 (UMLS CUI [1,1])
C0242485 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
Atrial Fibrillation by ECG Finding
Item
2. patients with atrial fibrillation detected on an electrocardiogram within the last 2 years prior to obtaining informed consent.
boolean
C0344434 (UMLS CUI [1])
Age
Item
3. age: 20 years old or older (at time of informed consent)
boolean
C0001779 (UMLS CUI [1])
Gender
Item
4. sex: male or female
boolean
C0079399 (UMLS CUI [1])
Outpatients
Item
5. clinical classification: outpatient
boolean
C0029921 (UMLS CUI [1])
Informed Consent
Item
6. patients who give written consent of agreement to voluntarily participate in the clinical study.
boolean
C0021430 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Liver disease Serious | Kidney Disease Serious
Item
1. patients with serious liver and/or kidney disease
boolean
C0023895 (UMLS CUI [1,1])
C0205404 (UMLS CUI [1,2])
C0022658 (UMLS CUI [2,1])
C0205404 (UMLS CUI [2,2])
Hypersensitivity Telmisartan | Amlodipine allergy
Item
2. patients with history of allergy to telmisartan or amlodipine
boolean
C0020517 (UMLS CUI [1,1])
C0248719 (UMLS CUI [1,2])
C0570921 (UMLS CUI [2])
Antihypertensive Agents | Exception Telmisartan | Exception Amlodipine
Item
3. patients receiving antihypertensives other than telmisartan or amlodipine during observation period
boolean
C0003364 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0248719 (UMLS CUI [2,2])
C1705847 (UMLS CUI [3,1])
C0051696 (UMLS CUI [3,2])
Persistent atrial fibrillation | Chronic atrial fibrillation | Permanent atrial fibrillation
Item
4. patients diagnosed with persistent atrial fibrillation or chronic (permanent) atrial fibrillation.
boolean
C2585653 (UMLS CUI [1])
C0694539 (UMLS CUI [2])
C2586056 (UMLS CUI [3])
Atrial Fibrillation caused by Illness | Cardiac Surgery procedures | Pulmonary Embolism | Hyperthyroidism
Item
5. patients with atrial fibrillation caused by irreversible illness (e.g., heart surgery, pulmonary embolism, or hyperthyroidism)
boolean
C0004238 (UMLS CUI [1,1])
C0015127 (UMLS CUI [1,2])
C0221423 (UMLS CUI [1,3])
C0018821 (UMLS CUI [2])
C0034065 (UMLS CUI [3])
C0020550 (UMLS CUI [4])
Average systolic blood pressure Hospital visit
Item
6. patients with average systolic blood pressure at hospital visit higher than 180 mmhg during observation period.
boolean
C1282151 (UMLS CUI [1,1])
C0545092 (UMLS CUI [1,2])
Heart failure New York Heart Association Classification | Heart failure Hospitalization Required | Impaired left ventricular function
Item
7. patients with new york heart association (nyha) class iii-iv heart failure, patients with heart failure requiring hospitalization, or patients with poor left ventricular function.
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0018801 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
C0242698 (UMLS CUI [3])
Cerebrovascular accident | Myocardial Infarction
Item
8. patients who have stroke or cardiac infarction within 6 months before giving consent.
boolean
C0038454 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
Ablation Surgery Pulmonary artery Planned | Operative Surgical Procedure Any Planned | Percutaneous Coronary Intervention Planned
Item
9. patients planning to undergo pulmonary artery ablation surgery or any surgical procedure (including pci).
boolean
C0547070 (UMLS CUI [1,1])
C0543467 (UMLS CUI [1,2])
C0034052 (UMLS CUI [1,3])
C1301732 (UMLS CUI [1,4])
C0543467 (UMLS CUI [2,1])
C1552551 (UMLS CUI [2,2])
C1301732 (UMLS CUI [2,3])
C1532338 (UMLS CUI [3,1])
C1301732 (UMLS CUI [3,2])
Breast Feeding | Pregnancy | Possible pregnancy | Pregnancy, Planned
Item
10. patients who are breast-feeding, pregnant, possibly pregnant, or plan to become pregnant.
boolean
C0006147 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Patients Ineligible Physician Decision
Item
11. in addition, patients who are determined as not eligible by their study doctor.
boolean
C0030705 (UMLS CUI [1,1])
C1512714 (UMLS CUI [1,2])
C1709536 (UMLS CUI [1,3])
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