ID

28749

Beschrijving

Stem Cell Therapy to Improve Myocardial Function in Patients Undergoing Coronary Artery Bypass Grafting (CABG); ODM derived from: https://clinicaltrials.gov/show/NCT00395811

Link

https://clinicaltrials.gov/show/NCT00395811

Trefwoorden

Versies (1)
  1. 31-01-18 31-01-18 -
Houder van rechten

See clinicaltrials.gov

Geüploaded op

31 januari 2018

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00395811

Engels

Eligibility Coronary Disease NCT00395811

1 Formulieren  
Inclusion Criteria
Beschrijving

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with coronary disease undergoing cabg.
Beschrijving

Coronary disease | Coronary Artery Bypass Surgery

Datatype

boolean

Alias
UMLS CUI [1]
C0010068
UMLS CUI [2]
C0010055
2. at least 3 months since last episode of myocardial infarction
Beschrijving

Myocardial Infarction | Episode Last Elapsed Time

Datatype

boolean

Alias
UMLS CUI [1]
C0027051
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C2826303
3. patients fulfilling either of the following criteria based on the extent of cad by coronary angiography and lvef by echocardiography.
Beschrijving

Criteria Fulfill | Coronary Artery Disease Coronary angiography | Left ventricular ejection fraction Echocardiography

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
UMLS CUI [2,1]
C1956346
UMLS CUI [2,2]
C0085532
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0013516
reversible myocardial ischemia as revealed by spect. ejection fraction >=40% <=50%. age >=18 years and <=70 patients who can give informed consent themselves in writing.
Beschrijving

Myocardial Ischemia Reversible SPECT | Cardiac ejection fraction | Age | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205343
UMLS CUI [1,3]
C0040399
UMLS CUI [2]
C0232174
UMLS CUI [3]
C0001779
UMLS CUI [4]
C0021430
4. negative pregnancy test (in women with childbearing potential).
Beschrijving

Childbearing Potential Pregnancy test negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C3831118
UMLS CUI [1,2]
C0427780
Exclusion Criteria
Beschrijving

Exclusion Criteria

Alias
UMLS CUI
C0680251
any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
Beschrijving

Criteria Fulfill

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1550543
1. sustained ventricular tachycardia in a 24-hour ecg.
Beschrijving

Sustained ventricular tachycardia 24 Hour ECG

Datatype

boolean

Alias
UMLS CUI [1,1]
C0750197
UMLS CUI [1,2]
C0430461
2. chronic atrial fibrillation.
Beschrijving

Chronic atrial fibrillation

Datatype

boolean

Alias
UMLS CUI [1]
C0694539
3. less than 3 months since last episode of cerebral infarction.
Beschrijving

Cerebral Infarction | Episode Last Elapsed Time

Datatype

boolean

Alias
UMLS CUI [1]
C0007785
UMLS CUI [2,1]
C0332189
UMLS CUI [2,2]
C1517741
UMLS CUI [2,3]
C2826303
4. patients with a malignant tumor*.
Beschrijving

Malignant Neoplasms

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
5. patients with chronic rheumatoid arthritis.
Beschrijving

Rheumatoid Arthritis chronic

Datatype

boolean

Alias
UMLS CUI [1,1]
C0003873
UMLS CUI [1,2]
C0205191
6. patients with a history of severe allergic reactions.
Beschrijving

Severe allergy

Datatype

boolean

Alias
UMLS CUI [1]
C2945656
7. patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
Beschrijving

Hematological Disease | Leukemia | Myeloproliferative disease | MYELODYSPLASTIC SYNDROME

Datatype

boolean

Alias
UMLS CUI [1]
C0018939
UMLS CUI [2]
C0023418
UMLS CUI [3]
C0027022
UMLS CUI [4]
C3463824
8. patients currently suffering from or having a history of interstitial pneumonitis.
Beschrijving

Pneumonitis, Interstitial

Datatype

boolean

Alias
UMLS CUI [1]
C0206061
9. leukocytes less than 4,000/µl or exceeding 10,000/µl.
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
10. platelets less than 100,000/µl.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
11. hemoglobin less than 10 g/dl.
Beschrijving

Hemoglobin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
12. ast (got) exceeding 100 iu/l or alt (gpt) exceeding 100 iu/l.
Beschrijving

Aspartate aminotransferase increased | Alanine aminotransferase increased

Datatype

boolean

Alias
UMLS CUI [1]
C0151904
UMLS CUI [2]
C0151905
13. patients for whom it is impossible to perform both cardiac mri
Beschrijving

MRI of Heart Both Perform Unsuccessful

Datatype

boolean

Alias
UMLS CUI [1,1]
C0412692
UMLS CUI [1,2]
C1706086
UMLS CUI [1,3]
C0884358
UMLS CUI [1,4]
C1272705
14. pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
Beschrijving

Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned

Datatype

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C0425965
UMLS CUI [4]
C0032992
15. any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
Beschrijving

Study Subject Participation Status Unsuitable for other reasons

Datatype

boolean

Alias
UMLS CUI [1,1]
C2348568
UMLS CUI [1,2]
C3844399
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Similar models

Eligibility Coronary Disease NCT00395811

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
C1512693 (UMLS CUI)
Coronary disease | Coronary Artery Bypass Surgery
Item
1. patients with coronary disease undergoing cabg.
boolean
C0010068 (UMLS CUI [1])
C0010055 (UMLS CUI [2])
Myocardial Infarction | Episode Last Elapsed Time
Item
2. at least 3 months since last episode of myocardial infarction
boolean
C0027051 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C2826303 (UMLS CUI [2,3])
Criteria Fulfill | Coronary Artery Disease Coronary angiography | Left ventricular ejection fraction Echocardiography
Item
3. patients fulfilling either of the following criteria based on the extent of cad by coronary angiography and lvef by echocardiography.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
C1956346 (UMLS CUI [2,1])
C0085532 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0013516 (UMLS CUI [3,2])
Myocardial Ischemia Reversible SPECT | Cardiac ejection fraction | Age | Informed Consent
Item
reversible myocardial ischemia as revealed by spect. ejection fraction >=40% <=50%. age >=18 years and <=70 patients who can give informed consent themselves in writing.
boolean
C0151744 (UMLS CUI [1,1])
C0205343 (UMLS CUI [1,2])
C0040399 (UMLS CUI [1,3])
C0232174 (UMLS CUI [2])
C0001779 (UMLS CUI [3])
C0021430 (UMLS CUI [4])
Childbearing Potential Pregnancy test negative
Item
4. negative pregnancy test (in women with childbearing potential).
boolean
C3831118 (UMLS CUI [1,1])
C0427780 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Criteria Fulfill
Item
any one of the following exclusion criteria is sufficient to disqualify a patient from the study.
boolean
C0243161 (UMLS CUI [1,1])
C1550543 (UMLS CUI [1,2])
Sustained ventricular tachycardia 24 Hour ECG
Item
1. sustained ventricular tachycardia in a 24-hour ecg.
boolean
C0750197 (UMLS CUI [1,1])
C0430461 (UMLS CUI [1,2])
Chronic atrial fibrillation
Item
2. chronic atrial fibrillation.
boolean
C0694539 (UMLS CUI [1])
Cerebral Infarction | Episode Last Elapsed Time
Item
3. less than 3 months since last episode of cerebral infarction.
boolean
C0007785 (UMLS CUI [1])
C0332189 (UMLS CUI [2,1])
C1517741 (UMLS CUI [2,2])
C2826303 (UMLS CUI [2,3])
Malignant Neoplasms
Item
4. patients with a malignant tumor*.
boolean
C0006826 (UMLS CUI [1])
Rheumatoid Arthritis chronic
Item
5. patients with chronic rheumatoid arthritis.
boolean
C0003873 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
Severe allergy
Item
6. patients with a history of severe allergic reactions.
boolean
C2945656 (UMLS CUI [1])
Hematological Disease | Leukemia | Myeloproliferative disease | MYELODYSPLASTIC SYNDROME
Item
7. patients with hematological disease (leukemia, myeloproliferative disease, or myelodysplastic syndromes).
boolean
C0018939 (UMLS CUI [1])
C0023418 (UMLS CUI [2])
C0027022 (UMLS CUI [3])
C3463824 (UMLS CUI [4])
Pneumonitis, Interstitial
Item
8. patients currently suffering from or having a history of interstitial pneumonitis.
boolean
C0206061 (UMLS CUI [1])
White Blood Cell Count procedure
Item
9. leukocytes less than 4,000/µl or exceeding 10,000/µl.
boolean
C0023508 (UMLS CUI [1])
Platelet Count measurement
Item
10. platelets less than 100,000/µl.
boolean
C0032181 (UMLS CUI [1])
Hemoglobin measurement
Item
11. hemoglobin less than 10 g/dl.
boolean
C0518015 (UMLS CUI [1])
Aspartate aminotransferase increased | Alanine aminotransferase increased
Item
12. ast (got) exceeding 100 iu/l or alt (gpt) exceeding 100 iu/l.
boolean
C0151904 (UMLS CUI [1])
C0151905 (UMLS CUI [2])
MRI of Heart Both Perform Unsuccessful
Item
13. patients for whom it is impossible to perform both cardiac mri
boolean
C0412692 (UMLS CUI [1,1])
C1706086 (UMLS CUI [1,2])
C0884358 (UMLS CUI [1,3])
C1272705 (UMLS CUI [1,4])
Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned
Item
14. pregnant or nursing patients, those who may be pregnant, or those who plan on becoming pregnant before the end of the study period.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C0425965 (UMLS CUI [3])
C0032992 (UMLS CUI [4])
Study Subject Participation Status Unsuitable for other reasons
Item
15. any other reason that the clinical supervisors or clinical researchers may have for considering a case unsuitable for the study.
boolean
C2348568 (UMLS CUI [1,1])
C3844399 (UMLS CUI [1,2])
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