ID

37571

Beskrivning

IntegRAted CarE for Atrial Fibrillation - RACE-4; ODM derived from: https://clinicaltrials.gov/show/NCT01740037

Länk

https://clinicaltrials.gov/show/NCT01740037

Nyckelord

Versioner (1)
  1. 2019-08-08 2019-08-08 -
Rättsinnehavare

See clinicaltrials.gov

Uppladdad den

8 augusti 2019

DOI

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Licens

Creative Commons BY 4.0
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Eligibility Atrial Fibrillation NCT01740037

Engelsk

Eligibility Atrial Fibrillation NCT01740037

1 Formulär  
Inclusion Criteria
Beskrivning

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with newly diagnosed af detected on electrocardiogram (ecg), holder recordings or event recorder with a duration > 30 seconds, in the 3 months before inclusion or
Beskrivning

Atrial Fibrillation Duration Electrocardiography | Atrial Fibrillation Duration Holter Electrocardiography | Atrial Fibrillation Duration Cardiac event recording

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0004238
UMLS CUI [1,2]
C0449238
UMLS CUI [1,3]
C1623258
UMLS CUI [2,1]
C0004238
UMLS CUI [2,2]
C0449238
UMLS CUI [2,3]
C0013801
UMLS CUI [3,1]
C0004238
UMLS CUI [3,2]
C0449238
UMLS CUI [3,3]
C1273297
2. patients with a history of diagnosed af, with no regular control at a cardiologist for af in the last 2 years and referred by a (non-)cardiologic medical specialist for new diagnostics or therapeutic issue;
Beskrivning

Atrial Fibrillation | Control Regular Lacking | Referral for Diagnostic procedure New | Referral for Problem Therapeutic

Datatyp

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2,1]
C2587213
UMLS CUI [2,2]
C0205272
UMLS CUI [2,3]
C0332268
UMLS CUI [3,1]
C2585524
UMLS CUI [3,2]
C0086143
UMLS CUI [3,3]
C0205314
UMLS CUI [4,1]
C2585524
UMLS CUI [4,2]
C0033213
UMLS CUI [4,3]
C0302350
3. age ≥18 years.
Beskrivning

Age

Datatyp

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Beskrivning

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. no electrocardiographic objectified af;
Beskrivning

Electrocardiography Lacking Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C1623258
UMLS CUI [1,2]
C0332268
UMLS CUI [1,3]
C0004238
2. unstable heart failure defined as nyha iv or heart failure necessitating hospital admission < 3 months before inclusion;
Beskrivning

Heart failure Unstable New York Heart Association Classification | Heart failure Hospitalization Required

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0443343
UMLS CUI [1,3]
C1275491
UMLS CUI [2,1]
C0018801
UMLS CUI [2,2]
C1708385
3. acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) < 3 months before inclusion;
Beskrivning

Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable | Chest Pain | Electrocardiographic changes Ischemic | Cardiac enzymes increased

Datatyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0027051
UMLS CUI [3]
C0002965
UMLS CUI [4]
C0008031
UMLS CUI [5,1]
C0855329
UMLS CUI [5,2]
C0475224
UMLS CUI [6]
C0741921
4. untreated hyperthyroidism or < 3 months euthyroidism before inclusion;
Beskrivning

Hyperthyroidism Untreated | Euthyroidism

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0020550
UMLS CUI [1,2]
C0332155
UMLS CUI [2]
C1848783
5. current or foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;
Beskrivning

Artificial cardiac pacemaker | Implantable defibrillator | Cardiac Resynchronization Therapy | Artificial cardiac pacemaker Planned | Implantable defibrillator Planned | Cardiac Resynchronization Therapy Planned

Datatyp

boolean

Alias
UMLS CUI [1]
C0030163
UMLS CUI [2]
C0162589
UMLS CUI [3]
C1167956
UMLS CUI [4,1]
C0030163
UMLS CUI [4,2]
C1301732
UMLS CUI [5,1]
C0162589
UMLS CUI [5,2]
C1301732
UMLS CUI [6,1]
C1167956
UMLS CUI [6,2]
C1301732
6. cardiac surgery ≤ 3 months before inclusion;
Beskrivning

Cardiac Surgery

Datatyp

boolean

Alias
UMLS CUI [1]
C0018821
7. planned cardiac surgery;
Beskrivning

Cardiac Surgery Planned

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0018821
UMLS CUI [1,2]
C1301732
8. regular control and treatment, also for af, at another specialized outpatient cardiac clinic;
Beskrivning

Control Regular | Treatment Regular | Control Regular Atrial Fibrillation; | Treatment Regular Atrial Fibrillation

Datatyp

boolean

Alias
UMLS CUI [1,1]
C2587213
UMLS CUI [1,2]
C0205272
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C0205272
UMLS CUI [3,1]
C2587213
UMLS CUI [3,2]
C0205272
UMLS CUI [3,3]
C0004238
UMLS CUI [4,1]
C0087111
UMLS CUI [4,2]
C0205272
UMLS CUI [4,3]
C0004238
9. patient is not able to fill in the questionnaires;
Beskrivning

Questionnaires Completion Unable

Datatyp

boolean

Alias
UMLS CUI [1,1]
C0034394
UMLS CUI [1,2]
C0205197
UMLS CUI [1,3]
C1299582
10. participation in other clinical study.
Beskrivning

Study Subject Participation Status

Datatyp

boolean

Alias
UMLS CUI [1]
C2348568
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Similar models

Eligibility Atrial Fibrillation NCT01740037

1 Formulär
Name
Typ
Description | Question | Decode (Coded Value)
Datatyp
Alias
Item Group
C1512693 (UMLS CUI)
Atrial Fibrillation Duration Electrocardiography | Atrial Fibrillation Duration Holter Electrocardiography | Atrial Fibrillation Duration Cardiac event recording
Item
1. patients with newly diagnosed af detected on electrocardiogram (ecg), holder recordings or event recorder with a duration > 30 seconds, in the 3 months before inclusion or
boolean
C0004238 (UMLS CUI [1,1])
C0449238 (UMLS CUI [1,2])
C1623258 (UMLS CUI [1,3])
C0004238 (UMLS CUI [2,1])
C0449238 (UMLS CUI [2,2])
C0013801 (UMLS CUI [2,3])
C0004238 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C1273297 (UMLS CUI [3,3])
Atrial Fibrillation | Control Regular Lacking | Referral for Diagnostic procedure New | Referral for Problem Therapeutic
Item
2. patients with a history of diagnosed af, with no regular control at a cardiologist for af in the last 2 years and referred by a (non-)cardiologic medical specialist for new diagnostics or therapeutic issue;
boolean
C0004238 (UMLS CUI [1])
C2587213 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C0332268 (UMLS CUI [2,3])
C2585524 (UMLS CUI [3,1])
C0086143 (UMLS CUI [3,2])
C0205314 (UMLS CUI [3,3])
C2585524 (UMLS CUI [4,1])
C0033213 (UMLS CUI [4,2])
C0302350 (UMLS CUI [4,3])
Age
Item
3. age ≥18 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Electrocardiography Lacking Atrial Fibrillation
Item
1. no electrocardiographic objectified af;
boolean
C1623258 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])
C0004238 (UMLS CUI [1,3])
Heart failure Unstable New York Heart Association Classification | Heart failure Hospitalization Required
Item
2. unstable heart failure defined as nyha iv or heart failure necessitating hospital admission < 3 months before inclusion;
boolean
C0018801 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0018801 (UMLS CUI [2,1])
C1708385 (UMLS CUI [2,2])
Acute Coronary Syndrome | Myocardial Infarction | Angina, Unstable | Chest Pain | Electrocardiographic changes Ischemic | Cardiac enzymes increased
Item
3. acute coronary syndrome (acute myocardial infarction or instable angina pectoris, with two of the following characteristics: chest pain and/ or ischemic electrocardiographic changes, and/ or cardiac enzyme rise) < 3 months before inclusion;
boolean
C0948089 (UMLS CUI [1])
C0027051 (UMLS CUI [2])
C0002965 (UMLS CUI [3])
C0008031 (UMLS CUI [4])
C0855329 (UMLS CUI [5,1])
C0475224 (UMLS CUI [5,2])
C0741921 (UMLS CUI [6])
Hyperthyroidism Untreated | Euthyroidism
Item
4. untreated hyperthyroidism or < 3 months euthyroidism before inclusion;
boolean
C0020550 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1848783 (UMLS CUI [2])
Artificial cardiac pacemaker | Implantable defibrillator | Cardiac Resynchronization Therapy | Artificial cardiac pacemaker Planned | Implantable defibrillator Planned | Cardiac Resynchronization Therapy Planned
Item
5. current or foreseen pacemaker, internal cardioverter defibrillator, and/ or cardiac resynchronization therapy;
boolean
C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C1167956 (UMLS CUI [3])
C0030163 (UMLS CUI [4,1])
C1301732 (UMLS CUI [4,2])
C0162589 (UMLS CUI [5,1])
C1301732 (UMLS CUI [5,2])
C1167956 (UMLS CUI [6,1])
C1301732 (UMLS CUI [6,2])
Cardiac Surgery
Item
6. cardiac surgery ≤ 3 months before inclusion;
boolean
C0018821 (UMLS CUI [1])
Cardiac Surgery Planned
Item
7. planned cardiac surgery;
boolean
C0018821 (UMLS CUI [1,1])
C1301732 (UMLS CUI [1,2])
Control Regular | Treatment Regular | Control Regular Atrial Fibrillation; | Treatment Regular Atrial Fibrillation
Item
8. regular control and treatment, also for af, at another specialized outpatient cardiac clinic;
boolean
C2587213 (UMLS CUI [1,1])
C0205272 (UMLS CUI [1,2])
C0087111 (UMLS CUI [2,1])
C0205272 (UMLS CUI [2,2])
C2587213 (UMLS CUI [3,1])
C0205272 (UMLS CUI [3,2])
C0004238 (UMLS CUI [3,3])
C0087111 (UMLS CUI [4,1])
C0205272 (UMLS CUI [4,2])
C0004238 (UMLS CUI [4,3])
Questionnaires Completion Unable
Item
9. patient is not able to fill in the questionnaires;
boolean
C0034394 (UMLS CUI [1,1])
C0205197 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Study Subject Participation Status
Item
10. participation in other clinical study.
boolean
C2348568 (UMLS CUI [1])
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