ID

28749

Descrição

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

Palavras-chave

Versões (1)
  1. 31/01/2018 31/01/2018 -
Titular dos direitos

See clinicaltrials.gov

Transferido a

31 de janeiro de 2018

DOI

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Licença

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00395811

Inglês

Eligibility Coronary Disease NCT00395811

1 Formulários  
Inclusion Criteria
Descrição

Inclusion Criteria

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

Coronary disease | Coronary Artery Bypass Surgery

Tipo de dados

boolean

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

Myocardial Infarction | Episode Last Elapsed Time

Tipo de dados

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.
Descrição

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

Tipo de dados

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.
Descrição

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

Tipo de dados

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).
Descrição

Childbearing Potential Pregnancy test negative

Tipo de dados

boolean

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

Exclusion Criteria

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

Criteria Fulfill

Tipo de dados

boolean

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

Sustained ventricular tachycardia 24 Hour ECG

Tipo de dados

boolean

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

Chronic atrial fibrillation

Tipo de dados

boolean

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

Cerebral Infarction | Episode Last Elapsed Time

Tipo de dados

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*.
Descrição

Malignant Neoplasms

Tipo de dados

boolean

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

Rheumatoid Arthritis chronic

Tipo de dados

boolean

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

Severe allergy

Tipo de dados

boolean

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

Hematological Disease | Leukemia | Myeloproliferative disease | MYELODYSPLASTIC SYNDROME

Tipo de dados

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.
Descrição

Pneumonitis, Interstitial

Tipo de dados

boolean

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

White Blood Cell Count procedure

Tipo de dados

boolean

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

Platelet Count measurement

Tipo de dados

boolean

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

Hemoglobin measurement

Tipo de dados

boolean

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

Aspartate aminotransferase increased | Alanine aminotransferase increased

Tipo de dados

boolean

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

MRI of Heart Both Perform Unsuccessful

Tipo de dados

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.
Descrição

Pregnancy | Breast Feeding | Possible pregnancy | Pregnancy, Planned

Tipo de dados

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.
Descrição

Study Subject Participation Status Unsuitable for other reasons

Tipo de dados

boolean

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

Eligibility Coronary Disease NCT00395811

1 Formulários
Name
Tipo
Description | Question | Decode (Coded Value)
Tipo de dados
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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