Eligibility Heart Failure NCT01420393

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StudyEvent: Eligibility
1. Eligibility Heart Failure NCT01420393

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Atrial Fibrillation Categories Quantity | Atrial Fibrillation by ECG Finding

Item

1. patients with one of the following af categories and at least one ecg documentation of af

boolean

C0004238 (UMLS CUI [1,1])
C0683312 (UMLS CUI [1,2])
C1265611 (UMLS CUI [1,3])
C0344434 (UMLS CUI [2])

Paroxysmal atrial fibrillation | Episode of Atrial Fibrillation Quantity | Episode Duration | Requirement Absent Electric Countershock

Item

high burden paroxysmal defined as ≥ 4 episodes of af in the last 6 months, and at least one episode > 6 hours (and no episode requiring cardioversion and no episode > 7 days)

boolean

C0235480 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
C0013778 (UMLS CUI [4,3])

Persistent atrial fibrillation | Episode of Atrial Fibrillation Quantity | Episode Duration | Requirement Electric Countershock

Item

persistent af (1) defined as ≥ 4 episodes of af in the last 6 months, and at least one episode > 6 hours, and at least one af episode less than 7 days but requires cardioversion. no af episodes are > 7 days

boolean

C2585653 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1265611 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
C1514873 (UMLS CUI [4,1])
C0013778 (UMLS CUI [4,2])

Persistent atrial fibrillation | Episode of Atrial Fibrillation Duration | Episode Quantity

Item

persistent af (2) as defined by at least one episode of af > 7 days but not > 1 year

boolean

C2585653 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])
C0332189 (UMLS CUI [3,1])
C1265611 (UMLS CUI [3,2])

Persistent atrial fibrillation Long-term | Episode of Atrial Fibrillation Duration

Item

long term persistent af defined as an af episode, at least one year in length and no episodes > 3 years

boolean

C2585653 (UMLS CUI [1,1])
C0443252 (UMLS CUI [1,2])
C0332189 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C0449238 (UMLS CUI [2,3])

Therapy Optimal Heart failure

Item

2. optimal therapy for heart failure of at least 6 weeks (according to 2009 accf/aha class 1 recommendations).

boolean

C0087111 (UMLS CUI [1,1])
C2698651 (UMLS CUI [1,2])
C0018801 (UMLS CUI [1,3])

Heart failure Symptoms New York Heart Association Classification | Ventricular Dysfunction, Left | Left ventricular ejection fraction | Left Ventricular Function Preserved

Item

3. hf with nyha class ii or iii symptoms with either impaired lv function (lvef ≤ 45%) as determined by ef assessment within the previous 12 months or preserved lv function (lvef > 45%) determined by by ef assessment within the previous 12 months

boolean

C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])
C0242698 (UMLS CUI [2])
C0428772 (UMLS CUI [3])
C0080310 (UMLS CUI [4,1])
C0033085 (UMLS CUI [4,2])

N-Terminal ProB-type Natriuretic Peptide Measurement

Item

4. nt-pro bnp measures:

boolean

C3272900 (UMLS CUI [1])

Hospitalization Due to Heart Failure | Patient Discharge

Item

a) patient has been hospitalized for heart failure* in the past 9 months, has been discharged and:

boolean

C3898876 (UMLS CUI [1])
C0030685 (UMLS CUI [2])

Normal sinus rhythm | N-Terminal ProB-type Natriuretic Peptide Measurement

Item

i- is presently in normal sinus rhythm and nt-pro bnp is ≥ 400 pg/ml

boolean

C0232202 (UMLS CUI [1])
C3272900 (UMLS CUI [2])

Atrial Fibrillation | N-Terminal ProB-type Natriuretic Peptide Measurement

Item

ii- is presently in atrial fibrillation and nt-pro bnp is ≥ 600 pg/ml

boolean

C0004238 (UMLS CUI [1])
C3272900 (UMLS CUI [2])

Hospitalization Due to Heart Failure Absent

Item

b) patient has had no hospitalization for heart failure in the past 9 months and:

boolean

C3898876 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])

Paroxysmal atrial fibrillation | Normal sinus rhythm | N-Terminal ProB-type Natriuretic Peptide Measurement

Item

i- has had paroxysmal atrial fibrillation, is presently in normal sinus rhythm and nt-probnp is ≥ 600 pg/ml

boolean

C0235480 (UMLS CUI [1])
C0232202 (UMLS CUI [2])
C3272900 (UMLS CUI [3])

Atrial Fibrillation | N-Terminal ProB-type Natriuretic Peptide Measurement

Item

ii- is presently in atrial fibrillation and nt-probnp is ≥ 900 pg/ml

boolean

C0004238 (UMLS CUI [1])
C3272900 (UMLS CUI [2])

Hospital admission Heart failure

Item

*heart failure admission is defined as admission to hospital > 24 hours and received treatment for heart failure

boolean

C0184666 (UMLS CUI [1,1])
C0018801 (UMLS CUI [1,2])

Patient Appropriate Catheter ablation for atrial fibrillation | Rate control Therapy Atrial Fibrillation

Item

5. suitable candidate for catheter ablation or rate control therapy for the treatment of af

boolean

C0030705 (UMLS CUI [1,1])
C1548787 (UMLS CUI [1,2])
C2702800 (UMLS CUI [1,3])
C0489879 (UMLS CUI [2,1])
C0087111 (UMLS CUI [2,2])
C0004238 (UMLS CUI [2,3])

Age

Item

6. age ≥18

boolean

C0001779 (UMLS CUI [1])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Left atrium Dimension Echocardiography

Item

1. have an la dimension > 55 mm as determined by an echocardiography within the previous year

boolean

C0225860 (UMLS CUI [1,1])
C0439534 (UMLS CUI [1,2])
C0013516 (UMLS CUI [1,3])

Acute Coronary Syndrome | Coronary Artery Bypass Surgery

Item

2. had an acute coronary syndrome or coronary artery bypass surgery within 12 weeks

boolean

C0948089 (UMLS CUI [1])
C0010055 (UMLS CUI [2])

Rheumatic Heart Disease | Aortic valve disorder Severe | Disease of mitral valve Severe

Item

3. have rheumatic heart disease, severe aortic or mitral valvular heart disease using the aha/acc guidelines

boolean

C0035439 (UMLS CUI [1])
C1260873 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0026265 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])

Congenital heart disease | Atrioseptoplasty Previous | Persistent left superior vena cava

Item

4. have congenital heart disease including previous asd repair, persistent left superior vena cava

boolean

C0152021 (UMLS CUI [1])
C0189965 (UMLS CUI [2,1])
C0205156 (UMLS CUI [2,2])
C0265931 (UMLS CUI [3])

Catheter ablation for atrial fibrillation Previous | Percutaneous Catheter Ablation Atrial Fibrillation | Ablation of atrioventricular node

Item

5. had prior surgical or percutaneous af ablation procedure or atrioventricular nodal (avn) ablation

boolean

C2702800 (UMLS CUI [1,1])
C0205156 (UMLS CUI [1,2])
C0162560 (UMLS CUI [2,1])
C0004238 (UMLS CUI [2,2])
C1998174 (UMLS CUI [3])

Medical condition Reduced life expectancy

Item

6. have a medical condition likely to limit survival to < 1 year

boolean

C3843040 (UMLS CUI [1,1])
C1858274 (UMLS CUI [1,2])

Heart failure Symptoms New York Heart Association Classification

Item

7. have new york heart association (nyha) class iv heart failure symptoms

boolean

C0018801 (UMLS CUI [1,1])
C1457887 (UMLS CUI [1,2])
C1275491 (UMLS CUI [1,3])

Medical contraindication Anticoagulation Therapy systematic

Item

8. have contraindication to systematic anticoagulation

boolean

C1301624 (UMLS CUI [1,1])
C0003281 (UMLS CUI [1,2])
C0220922 (UMLS CUI [1,3])

Kidney Failure Requirement Dialysis

Item

9. have renal failure requiring dialysis

boolean

C0035078 (UMLS CUI [1,1])
C1514873 (UMLS CUI [1,2])
C0011946 (UMLS CUI [1,3])

Atrial Fibrillation Due to Cause Reversible | Hyperthyroidism

Item

10. af due to reversible cause e.g. hyperthyroid state

boolean

C0004238 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0015127 (UMLS CUI [1,3])
C0205343 (UMLS CUI [1,4])
C0020550 (UMLS CUI [2])

Pregnancy

Item

11. are pregnant

boolean

C0032961 (UMLS CUI [1])

Study Subject Participation Status Affecting Completion of clinical trial

Item

12. are included in other clinical trials that will affect the objectives of this study

boolean

C2348568 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C2732579 (UMLS CUI [1,3])

Treatment Compliance Lacking

Item

13. have a history of non-compliance to medical therapy

boolean

C4319828 (UMLS CUI [1,1])
C0332268 (UMLS CUI [1,2])

Informed Consent Unable | Informed Consent Unwilling

Item

14. are unable or unwilling to provide informed consent

boolean

C0021430 (UMLS CUI [1,1])
C1299582 (UMLS CUI [1,2])
C0021430 (UMLS CUI [2,1])
C0558080 (UMLS CUI [2,2])

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Eligibility Heart Failure NCT01420393