Eligibility Heart Failure NCT01297296

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StudyEvent: Eligibility
1. Eligibility Heart Failure NCT01297296

Name

Tipo

Description | Question | Decode (Coded Value)

Tipo de dados

Alias

Inclusion Criteria

Item Group

C1512693 (UMLS CUI)

Inclusion criteria All Fulfill

Item

candidates for this study must meet all of the following inclusion criteria:

boolean

C1512693 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])

Akinesia Due to MYOCARDIAL INFARCTION ANTEROAPICAL | Dyskinesis Due to MYOCARDIAL INFARCTION ANTEROAPICAL

Item

1. akinesis or dyskinesis due to myocardial infarction limited to anteroapical region

boolean

C0085623 (UMLS CUI [1,1])
C0678226 (UMLS CUI [1,2])
C0746714 (UMLS CUI [1,3])
C0013384 (UMLS CUI [2,1])
C0678226 (UMLS CUI [2,2])
C0746714 (UMLS CUI [2,3])

Hospitalization Absent

Item

2. subject is not hospitalized at time of enrollment.

boolean

C0019993 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])

New York Heart Association Classification

Item

3. nyha class at time of enrollment, either:

boolean

C1275491 (UMLS CUI [1])

New York Heart Association Classification | New York Heart Association Classification Ambulatory

Item

nyha class iii or ambulatory iv - if predominant during the 3-month period prior to enrollment

boolean

C1275491 (UMLS CUI [1])
C1275491 (UMLS CUI [2,1])
C1561561 (UMLS CUI [2,2])

New York Heart Association Classification

Item

nyha class ii - if diagnosed with nyha class iii or iv during 3-month period prior to enrollment

boolean

C1275491 (UMLS CUI [1])

Left ventricular ejection fraction Echocardiography

Item

4. lvef >15 or% and ≤ 40% as measured by echocardiography.

boolean

C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])

Status post Left ventricle Myocardial Infarction | Heart dysfunction structural | Left ventricular wall motion abnormality Echocardiography

Item

5. post lv mi structural heart dysfunction represented by lv wall motion abnormality (wma) by echocardiography.

boolean

C0231290 (UMLS CUI [1,1])
C0225897 (UMLS CUI [1,2])
C0027051 (UMLS CUI [1,3])
C0340515 (UMLS CUI [2,1])
C0678594 (UMLS CUI [2,2])
C1997551 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])

Eligibility Cardiac Surgery

Item

6. eligible for cardiac surgery

boolean

C1548635 (UMLS CUI [1,1])
C0018821 (UMLS CUI [1,2])

Age

Item

7. between 18 and 79 years of age (inclusive)

boolean

C0001779 (UMLS CUI [1])

Therapy Heart failure

Item

8. receiving appropriate medical treatment for heart failure according to the acc/aha 2009 guideline update for the diagnosis and management of chronic heart failure in the adult during the three months prior to enrollment

boolean

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

Informed Consent

Item

9. provide written informed consent

boolean

C0021430 (UMLS CUI [1])

Agreement Clinical Study Follow-up

Item

10. agree to the protocol-required follow-up

boolean

C0680240 (UMLS CUI [1,1])
C3274571 (UMLS CUI [1,2])

Exclusion Criteria

Item Group

C0680251 (UMLS CUI)

Criteria Any Fulfill

Item

candidates will be excluded from the study if any of the following conditions apply:

boolean

C0243161 (UMLS CUI [1,1])
C1552551 (UMLS CUI [1,2])
C1550543 (UMLS CUI [1,3])

Coronary Artery Disease Untreated | Requirement Intervention

Item

1. untreated clinically significant coronary artery disease requiring intervention.

boolean

C1956346 (UMLS CUI [1,1])
C0332155 (UMLS CUI [1,2])
C1514873 (UMLS CUI [2,1])
C0184661 (UMLS CUI [2,2])

Myocardial Infarction | Myocardial Infarction Suspected

Item

2. acute mi (see mi definition) within 60 days of enrollment or patients with suspected evolving mi at time of enrollment

boolean

C0027051 (UMLS CUI [1])
C0027051 (UMLS CUI [2,1])
C0750491 (UMLS CUI [2,2])

Shock, Cardiogenic

Item

3. cardiogenic shock within 72 hours of enrollment

boolean

C0036980 (UMLS CUI [1])

Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery

Item

4. revascularization procedure (pci or cabg) within 60 days of enrollment

boolean

C0581603 (UMLS CUI [1])
C1532338 (UMLS CUI [2])
C0010055 (UMLS CUI [3])

Artificial cardiac pacemaker | ICD | Implantation of CRT-D

Item

5. patient has received a pacemaker, icd, or crt device within 60 days of enrollment

boolean

C0030163 (UMLS CUI [1])
C0162589 (UMLS CUI [2])
C1135480 (UMLS CUI [3])

Sudden Cardiac Death aborted | Implantable defibrillator Absent | Ventricular arrhythmia Lethal | Ventricular Tachycardia Lethal | Ventricular Fibrillation Lethal

Item

6. history of aborted sudden cardiac death, if patient has not received an icd and has potentially lethal ventricular arrhythmia, vt or vf

boolean

C0085298 (UMLS CUI [1,1])
C1609614 (UMLS CUI [1,2])
C0162589 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0085612 (UMLS CUI [3,1])
C3151529 (UMLS CUI [3,2])
C0042514 (UMLS CUI [4,1])
C3151529 (UMLS CUI [4,2])
C0042510 (UMLS CUI [5,1])
C3151529 (UMLS CUI [5,2])

Item

7. a known hypersensitivity or contraindication to aspirin, heparin, warfarin, nitinol (titanium and nickel alloy), or sensitivity to contrast media, which cannot be adequately pre medicated.

boolean

C0004058 (UMLS CUI [1])
C1301624 (UMLS CUI [2,1])
C0004057 (UMLS CUI [2,2])
C0571776 (UMLS CUI [3])
C1301624 (UMLS CUI [4,1])
C0019134 (UMLS CUI [4,2])
C0571785 (UMLS CUI [5])
C1301624 (UMLS CUI [6,1])
C0043031 (UMLS CUI [6,2])
C0020517 (UMLS CUI [7,1])
C0068790 (UMLS CUI [7,2])
C1301624 (UMLS CUI [8,1])
C0068790 (UMLS CUI [8,2])
C0570562 (UMLS CUI [9])

Replacement of aortic valve | Aortic Valve Repair

Item

8. aortic valve replacement or repair

boolean

C0003506 (UMLS CUI [1])
C0869750 (UMLS CUI [2])

Hematological Disease | Bleeding tendency | Blood Coagulation Disorders | Thrombophilia

Item

9. blood dyscrasia, history of bleeding diathesis or coagulopathy, or hypercoagulable states.

boolean

C0018939 (UMLS CUI [1])
C1458140 (UMLS CUI [2])
C0005779 (UMLS CUI [3])
C0398623 (UMLS CUI [4])

Peptic Ulcer | Gastrointestinal Hemorrhage

Item

10. active peptic ulcer or gi bleeding within the past 3 months

boolean

C0030920 (UMLS CUI [1])
C0017181 (UMLS CUI [2])

Cerebrovascular accident | Transient Ischemic Attack

Item

11. patient has suffered a cerebrovascular accident (cva) or transient ischemic attack (tia) within the past 6 months

boolean

C0038454 (UMLS CUI [1])
C0007787 (UMLS CUI [2])

Kawasaki's disease

Item

12. history of kawasaki's disease

boolean

C0026691 (UMLS CUI [1])

Dialysis | Requirement Hemodialysis

Item

13. patient on dialysis or expected to require hemodialysis within 12 months

boolean

C0011946 (UMLS CUI [1])
C1514873 (UMLS CUI [2,1])
C0019004 (UMLS CUI [2,2])

Chronic liver disease

Item

14. patient has chronic liver disease

boolean

C0341439 (UMLS CUI [1])

Renal Insufficiency | At risk Kidney Failure Contrast Induced

Item

15. impaired renal function that places patient at risk of contrast induced renal failure

boolean

C1565489 (UMLS CUI [1])
C1444641 (UMLS CUI [2,1])
C0035078 (UMLS CUI [2,2])
C0009924 (UMLS CUI [2,3])
C0205263 (UMLS CUI [2,4])

Sepsis | Endocarditis

Item

16. ongoing sepsis, including active endocarditis.

boolean

C0243026 (UMLS CUI [1])
C0014118 (UMLS CUI [2])

Comorbidity Associated with Life Expectancy | Factor Echocardiography Difficult | Factor Clinical Study Follow-up Difficult | Patient address Permanent Lacking

Item

17. co-morbidities associated with a life expectancy of less than 12-months or there are factors making echo and clinical follow-up difficult (no permanent address, etc.)

boolean

C0009488 (UMLS CUI [1,1])
C0332281 (UMLS CUI [1,2])
C0023671 (UMLS CUI [1,3])
C1521761 (UMLS CUI [2,1])
C0013516 (UMLS CUI [2,2])
C0332218 (UMLS CUI [2,3])
C1521761 (UMLS CUI [3,1])
C3274571 (UMLS CUI [3,2])
C0332218 (UMLS CUI [3,3])
C0421449 (UMLS CUI [4,1])
C0205355 (UMLS CUI [4,2])
C0332268 (UMLS CUI [4,3])

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Eligibility Heart Failure NCT01297296