ID

20831

Description

Cell Repair in Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT00285454

Link

https://clinicaltrials.gov/show/NCT00285454

Keywords

Versions (1)
  1. 3/21/17 3/21/17 -
Uploaded on

March 21, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Heart Failure NCT00285454

English

Eligibility Heart Failure NCT00285454

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. symptomatic ischaemic multi-vessel coronary artery disease (cad) not suitable for standard revascularization procedures such as cabg, pci, lvad, or heart transplant.
Description

Multi vessel coronary artery disease Ischemic Symptomatic | Revascularization Standard Inappropriate | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Left ventricular assist device | Heart Transplantation

Data type

boolean

Alias
UMLS CUI [1,1]
C1299432
UMLS CUI [1,2]
C0475224
UMLS CUI [1,3]
C0231220
UMLS CUI [2,1]
C0581603
UMLS CUI [2,2]
C1442989
UMLS CUI [2,3]
C1548788
UMLS CUI [3]
C0010055
UMLS CUI [4]
C1532338
UMLS CUI [5]
C0181598
UMLS CUI [6]
C0018823
2. area of reversible inducible ischaemia (>10% of lv on spect) performed not more than six months prior to study treatment.
Description

Ischemia Inducible Reversible | Left ventricle Percentage Single-Photon Emission-Computed Tomography

Data type

boolean

Alias
UMLS CUI [1,1]
C0022116
UMLS CUI [1,2]
C0205263
UMLS CUI [1,3]
C0205343
UMLS CUI [2,1]
C1269892
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0040399
3. lvef < 45% on optimal medical therapy.
Description

Left ventricular ejection fraction | Therapeutic procedure Optimal

Data type

boolean

Alias
UMLS CUI [1]
C0428772
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
4. nyha class ii- iv patient stable on optimal medical therapy for at least 30 days.
Description

New York Heart Association Classification | Therapeutic procedure Optimal Stable

Data type

boolean

Alias
UMLS CUI [1]
C1275491
UMLS CUI [2,1]
C0087111
UMLS CUI [2,2]
C2698651
UMLS CUI [2,3]
C0205360
5. written informed consent and agree to attend hospital appointments for 1 year.
Description

Informed Consent | Compliance behavior

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2]
C1321605
6. male and females 18 to 80 years of age.
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. left ventricular aneurysm or thrombus.
Description

Left ventricular aneurysm | Left ventricular thrombus

Data type

boolean

Alias
UMLS CUI [1]
C0519097
UMLS CUI [2]
C0587044
2. thoracic aortic aneurysm.
Description

Aortic Aneurysm, Thoracic

Data type

boolean

Alias
UMLS CUI [1]
C0162872
3. congenital heart disease
Description

Congenital heart disease

Data type

boolean

Alias
UMLS CUI [1]
C0152021
4. acute unstable angina, idiopathic cardiomyopathy, life-threatening ventricular arrhythmias, recent (less than 6 weeks).
Description

Angina, Unstable | Cardiomyopathies, Primary | Ventricular arrhythmia Life Threatening

Data type

boolean

Alias
UMLS CUI [1]
C0002965
UMLS CUI [2]
C0033141
UMLS CUI [3,1]
C0085612
UMLS CUI [3,2]
C2826244
5. contraindication to mri or any other study procedure.
Description

Medical contraindication MRI | Medical contraindication Clinical Trial procedure

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0024485
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0008976
UMLS CUI [2,3]
C0184661
6. presence or history of cancer (except low grade and fully resolved non-melanoma skin malignancy).
Description

Malignant Neoplasms | Skin carcinoma Low grade Resolved

Data type

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C0699893
UMLS CUI [2,2]
C1282907
UMLS CUI [2,3]
C1514893
7. any co-morbidity likely to reduce short- term survival or which may interfere with functional testing.
Description

Comorbidity Reducing Survival short-term | Comorbidity Interferes with Testing Functional

Data type

boolean

Alias
UMLS CUI [1,1]
C0009488
UMLS CUI [1,2]
C0392756
UMLS CUI [1,3]
C0038952
UMLS CUI [1,4]
C0443303
UMLS CUI [2,1]
C0009488
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0039593
UMLS CUI [2,4]
C0205245
8. recent myocardial infarction < 6mths.
Description

Myocardial Infarction

Data type

boolean

Alias
UMLS CUI [1]
C0027051
9. cerebral vascular accident < 6mths.
Description

Cerebrovascular accident

Data type

boolean

Alias
UMLS CUI [1]
C0038454
10. active hepatitis, receiving immunosuppressive therapy, undergoing haemodialysis.
Description

Hepatitis | Therapeutic immunosuppression | Hemodialysis

Data type

boolean

Alias
UMLS CUI [1]
C0019158
UMLS CUI [2]
C0021079
UMLS CUI [3]
C0019004
11. clinically significant abnormal haematology.
Description

Hematology finding abnormal

Data type

boolean

Alias
UMLS CUI [1]
C0475182
12. recent history of alcoholism, drug abuse, or severe emotional, behavioural, or psychiatric problems.
Description

Alcoholic Intoxication, Chronic | Drug abuse | Emotional problems Severe | Abnormal behavior Severe | Psychiatric problem Severe

Data type

boolean

Alias
UMLS CUI [1]
C0001973
UMLS CUI [2]
C0013146
UMLS CUI [3,1]
C0677660
UMLS CUI [3,2]
C0205082
UMLS CUI [4,1]
C0233514
UMLS CUI [4,2]
C0205082
UMLS CUI [5,1]
C1306597
UMLS CUI [5,2]
C0205082
13. fertile women who are pregnant, nursing, or using no form of contraception.
Description

Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Missing

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3,1]
C3831118
UMLS CUI [3,2]
C0700589
UMLS CUI [3,3]
C1705492
14. receiving experimental medications or participating in another study within 12 weeks of enrolment into this study.
Description

Investigational New Drugs | Study Subject Participation Status

Data type

boolean

Alias
UMLS CUI [1]
C0013230
UMLS CUI [2]
C2348568
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Similar models

Eligibility Heart Failure NCT00285454

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Multi vessel coronary artery disease Ischemic Symptomatic | Revascularization Standard Inappropriate | Coronary Artery Bypass Surgery | Percutaneous Coronary Intervention | Left ventricular assist device | Heart Transplantation
Item
1. symptomatic ischaemic multi-vessel coronary artery disease (cad) not suitable for standard revascularization procedures such as cabg, pci, lvad, or heart transplant.
boolean
C1299432 (UMLS CUI [1,1])
C0475224 (UMLS CUI [1,2])
C0231220 (UMLS CUI [1,3])
C0581603 (UMLS CUI [2,1])
C1442989 (UMLS CUI [2,2])
C1548788 (UMLS CUI [2,3])
C0010055 (UMLS CUI [3])
C1532338 (UMLS CUI [4])
C0181598 (UMLS CUI [5])
C0018823 (UMLS CUI [6])
Ischemia Inducible Reversible | Left ventricle Percentage Single-Photon Emission-Computed Tomography
Item
2. area of reversible inducible ischaemia (>10% of lv on spect) performed not more than six months prior to study treatment.
boolean
C0022116 (UMLS CUI [1,1])
C0205263 (UMLS CUI [1,2])
C0205343 (UMLS CUI [1,3])
C1269892 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0040399 (UMLS CUI [2,3])
Left ventricular ejection fraction | Therapeutic procedure Optimal
Item
3. lvef < 45% on optimal medical therapy.
boolean
C0428772 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
New York Heart Association Classification | Therapeutic procedure Optimal Stable
Item
4. nyha class ii- iv patient stable on optimal medical therapy for at least 30 days.
boolean
C1275491 (UMLS CUI [1])
C0087111 (UMLS CUI [2,1])
C2698651 (UMLS CUI [2,2])
C0205360 (UMLS CUI [2,3])
Informed Consent | Compliance behavior
Item
5. written informed consent and agree to attend hospital appointments for 1 year.
boolean
C0021430 (UMLS CUI [1])
C1321605 (UMLS CUI [2])
Age
Item
6. male and females 18 to 80 years of age.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Left ventricular aneurysm | Left ventricular thrombus
Item
1. left ventricular aneurysm or thrombus.
boolean
C0519097 (UMLS CUI [1])
C0587044 (UMLS CUI [2])
Aortic Aneurysm, Thoracic
Item
2. thoracic aortic aneurysm.
boolean
C0162872 (UMLS CUI [1])
Congenital heart disease
Item
3. congenital heart disease
boolean
C0152021 (UMLS CUI [1])
Angina, Unstable | Cardiomyopathies, Primary | Ventricular arrhythmia Life Threatening
Item
4. acute unstable angina, idiopathic cardiomyopathy, life-threatening ventricular arrhythmias, recent (less than 6 weeks).
boolean
C0002965 (UMLS CUI [1])
C0033141 (UMLS CUI [2])
C0085612 (UMLS CUI [3,1])
C2826244 (UMLS CUI [3,2])
Medical contraindication MRI | Medical contraindication Clinical Trial procedure
Item
5. contraindication to mri or any other study procedure.
boolean
C1301624 (UMLS CUI [1,1])
C0024485 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0008976 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Malignant Neoplasms | Skin carcinoma Low grade Resolved
Item
6. presence or history of cancer (except low grade and fully resolved non-melanoma skin malignancy).
boolean
C0006826 (UMLS CUI [1])
C0699893 (UMLS CUI [2,1])
C1282907 (UMLS CUI [2,2])
C1514893 (UMLS CUI [2,3])
Comorbidity Reducing Survival short-term | Comorbidity Interferes with Testing Functional
Item
7. any co-morbidity likely to reduce short- term survival or which may interfere with functional testing.
boolean
C0009488 (UMLS CUI [1,1])
C0392756 (UMLS CUI [1,2])
C0038952 (UMLS CUI [1,3])
C0443303 (UMLS CUI [1,4])
C0009488 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0039593 (UMLS CUI [2,3])
C0205245 (UMLS CUI [2,4])
Myocardial Infarction
Item
8. recent myocardial infarction < 6mths.
boolean
C0027051 (UMLS CUI [1])
Cerebrovascular accident
Item
9. cerebral vascular accident < 6mths.
boolean
C0038454 (UMLS CUI [1])
Hepatitis | Therapeutic immunosuppression | Hemodialysis
Item
10. active hepatitis, receiving immunosuppressive therapy, undergoing haemodialysis.
boolean
C0019158 (UMLS CUI [1])
C0021079 (UMLS CUI [2])
C0019004 (UMLS CUI [3])
Hematology finding abnormal
Item
11. clinically significant abnormal haematology.
boolean
C0475182 (UMLS CUI [1])
Alcoholic Intoxication, Chronic | Drug abuse | Emotional problems Severe | Abnormal behavior Severe | Psychiatric problem Severe
Item
12. recent history of alcoholism, drug abuse, or severe emotional, behavioural, or psychiatric problems.
boolean
C0001973 (UMLS CUI [1])
C0013146 (UMLS CUI [2])
C0677660 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
C0233514 (UMLS CUI [4,1])
C0205082 (UMLS CUI [4,2])
C1306597 (UMLS CUI [5,1])
C0205082 (UMLS CUI [5,2])
Pregnancy | Breast Feeding | Childbearing Potential Contraceptive methods Missing
Item
13. fertile women who are pregnant, nursing, or using no form of contraception.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3,1])
C0700589 (UMLS CUI [3,2])
C1705492 (UMLS CUI [3,3])
Investigational New Drugs | Study Subject Participation Status
Item
14. receiving experimental medications or participating in another study within 12 weeks of enrolment into this study.
boolean
C0013230 (UMLS CUI [1])
C2348568 (UMLS CUI [2])
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