ID

28086

Beschreibung

Mesenchymal Stem Cells and Myocardial Ischemia; ODM derived from: https://clinicaltrials.gov/show/NCT01076920

Link

https://clinicaltrials.gov/show/NCT01076920

Stichworte

Versionen (1)
  1. 17.12.17 17.12.17 -
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See clinicaltrials.gov

Hochgeladen am

17. Dezember 2017

DOI

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Eligibility Chronic Myocardial Ischemia NCT01076920

Englisch

Eligibility Chronic Myocardial Ischemia NCT01076920

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. age 18 to 75
Beschreibung

Age

Datentyp

boolean

Alias
UMLS CUI [1]
C0001779
2. male or female
Beschreibung

Gender

Datentyp

boolean

Alias
UMLS CUI [1]
C0079399
3. nyha (heart failure) class ii-iv or angina pectoris ccs class iii or iv or symptoms consistent with)
Beschreibung

Heart failure New York Heart Association Classification | Angina Pectoris Canadian Cardiovascular Society Grading Scale Class | Symptoms Consistent with

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C1275491
UMLS CUI [2,1]
C0002962
UMLS CUI [2,2]
C1879987
UMLS CUI [3,1]
C1457887
UMLS CUI [3,2]
C0332290
4. chronic coronary artery disease with left ventricular function below 35%
Beschreibung

Coronary Artery Disease chronic | Left Ventricular Function

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0205191
UMLS CUI [2]
C0080310
5. stable medical therapy for at least one month
Beschreibung

Therapeutic procedure Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0087111
UMLS CUI [1,2]
C0205360
6. reversible perfusion defects by spect
Beschreibung

Reversible myocardial perfusion defect SPECT

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0428859
UMLS CUI [1,2]
C0040399
7. not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
Beschreibung

Patients Inappropriate Coronary Artery Bypass Surgery | Cause Target Poor | Cause Small blood vessel | Patients Inappropriate Percutaneous Coronary Intervention | Coronary Vessel Lesion Access Unsuccessful | Cause Anatomy aspects

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1548788
UMLS CUI [1,3]
C0010055
UMLS CUI [2,1]
C0015127
UMLS CUI [2,2]
C1521840
UMLS CUI [2,3]
C2700379
UMLS CUI [3,1]
C0015127
UMLS CUI [3,2]
C0225988
UMLS CUI [4,1]
C0030705
UMLS CUI [4,2]
C1548788
UMLS CUI [4,3]
C1532338
UMLS CUI [5,1]
C3272304
UMLS CUI [5,2]
C0444454
UMLS CUI [5,3]
C1272705
UMLS CUI [6,1]
C0015127
UMLS CUI [6,2]
C1384516
8. implantable cardiovertor defibrillator
Beschreibung

Implantable defibrillator

Datentyp

boolean

Alias
UMLS CUI [1]
C0162589
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. acute coronary syndrome, revascularization (pci or cabg), or cardiac resynchronization during the last 3 months
Beschreibung

Acute Coronary Syndrome | Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Cardiac Resynchronization Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0948089
UMLS CUI [2]
C0581603
UMLS CUI [3]
C1532338
UMLS CUI [4]
C0010055
UMLS CUI [5]
C1167956
2. sustained ventricular
Beschreibung

Sustained ventricular tachycardia

Datentyp

boolean

Alias
UMLS CUI [1]
C0750197
3. further revascularization planned for the next 30 days.
Beschreibung

Revascularization Additional Planned

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0581603
UMLS CUI [1,2]
C1524062
UMLS CUI [1,3]
C1301732
4. chronic atrial fibrillation.
Beschreibung

Chronic atrial fibrillation

Datentyp

boolean

Alias
UMLS CUI [1]
C0694539
5. a wall thickness in the target region <8 mm as determined by 2d echocardiography (the target region is defined at the time of noga® mapping).
Beschreibung

Target region Wall thickness Echocardiography | Other Coding

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1521840
UMLS CUI [1,2]
C0205147
UMLS CUI [1,3]
C0442069
UMLS CUI [1,4]
C1280412
UMLS CUI [1,5]
C0013516
UMLS CUI [2]
C3846158
6. an lv thrombus.
Beschreibung

Left ventricular thrombus

Datentyp

boolean

Alias
UMLS CUI [1]
C0587044
7. severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
Beschreibung

Peripheral Vascular Disease Severe | Femoral artery Access Excluded | Catheterization

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0085096
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C0015801
UMLS CUI [2,2]
C0444454
UMLS CUI [2,3]
C0332196
UMLS CUI [3]
C0007430
8. aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the lv.
Beschreibung

Aortic Valve Stenosis | Catheter Access Left ventricle Excluded

Datentyp

boolean

Alias
UMLS CUI [1]
C0003507
UMLS CUI [2,1]
C0441134
UMLS CUI [2,2]
C0444454
UMLS CUI [2,3]
C0225897
UMLS CUI [2,4]
C0332196
9. human immunodeficiency virus (hiv1-2), htlv-1 and 2.
Beschreibung

HIV-1 | HIV-2 | Human T-lymphotropic virus 1 | Human T-lymphotropic virus 2

Datentyp

boolean

Alias
UMLS CUI [1]
C0019704
UMLS CUI [2]
C0019707
UMLS CUI [3]
C0020094
UMLS CUI [4]
C0020099
10. an active uncontrolled infection.
Beschreibung

Communicable Disease Uncontrolled

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0009450
UMLS CUI [1,2]
C0205318
11. a prosthetic aortic valve.
Beschreibung

Aortic valve prosthesis

Datentyp

boolean

Alias
UMLS CUI [1]
C0182431
12. a current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
Beschreibung

Neoplasm | Exception Basal cell carcinoma

Datentyp

boolean

Alias
UMLS CUI [1]
C0027651
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0007117
13. pregnancy or breastfeeding.
Beschreibung

Pregnancy | Breast Feeding

Datentyp

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
14. active participation in other research therapy for cardiovascular repair/regeneration.
Beschreibung

Investigational Therapy Repair cardiovascular | Investigational Therapy Regeneration Cardiovascular

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0949266
UMLS CUI [1,2]
C0849442
UMLS CUI [2,1]
C0949266
UMLS CUI [2,2]
C0349676
UMLS CUI [2,3]
C3887460
15. any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
Beschreibung

Medical condition Affecting Evaluation Patient condition | Medical condition compromises Patient safety

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0392760
UMLS CUI [1,3]
C1261322
UMLS CUI [1,4]
C0683521
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C1113679
16. any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.
Beschreibung

Condition Study Subject Participation Status Excluded

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C2828389
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Ähnliche Modelle

Eligibility Chronic Myocardial Ischemia NCT01076920

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Age
Item
1. age 18 to 75
boolean
C0001779 (UMLS CUI [1])
Gender
Item
2. male or female
boolean
C0079399 (UMLS CUI [1])
Heart failure New York Heart Association Classification | Angina Pectoris Canadian Cardiovascular Society Grading Scale Class | Symptoms Consistent with
Item
3. nyha (heart failure) class ii-iv or angina pectoris ccs class iii or iv or symptoms consistent with)
boolean
C0018801 (UMLS CUI [1,1])
C1275491 (UMLS CUI [1,2])
C0002962 (UMLS CUI [2,1])
C1879987 (UMLS CUI [2,2])
C1457887 (UMLS CUI [3,1])
C0332290 (UMLS CUI [3,2])
Coronary Artery Disease chronic | Left Ventricular Function
Item
4. chronic coronary artery disease with left ventricular function below 35%
boolean
C1956346 (UMLS CUI [1,1])
C0205191 (UMLS CUI [1,2])
C0080310 (UMLS CUI [2])
Therapeutic procedure Stable
Item
5. stable medical therapy for at least one month
boolean
C0087111 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Reversible myocardial perfusion defect SPECT
Item
6. reversible perfusion defects by spect
boolean
C0428859 (UMLS CUI [1,1])
C0040399 (UMLS CUI [1,2])
Patients Inappropriate Coronary Artery Bypass Surgery | Cause Target Poor | Cause Small blood vessel | Patients Inappropriate Percutaneous Coronary Intervention | Coronary Vessel Lesion Access Unsuccessful | Cause Anatomy aspects
Item
7. not a candidate for coronary artery by-pass surgery due to poor targets or small vessels and not a candidate for percutaneous intervention due to small vessels or unreachable coronary lesions due to complicated anatomy
boolean
C0030705 (UMLS CUI [1,1])
C1548788 (UMLS CUI [1,2])
C0010055 (UMLS CUI [1,3])
C0015127 (UMLS CUI [2,1])
C1521840 (UMLS CUI [2,2])
C2700379 (UMLS CUI [2,3])
C0015127 (UMLS CUI [3,1])
C0225988 (UMLS CUI [3,2])
C0030705 (UMLS CUI [4,1])
C1548788 (UMLS CUI [4,2])
C1532338 (UMLS CUI [4,3])
C3272304 (UMLS CUI [5,1])
C0444454 (UMLS CUI [5,2])
C1272705 (UMLS CUI [5,3])
C0015127 (UMLS CUI [6,1])
C1384516 (UMLS CUI [6,2])
Implantable defibrillator
Item
8. implantable cardiovertor defibrillator
boolean
C0162589 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Acute Coronary Syndrome | Revascularization | Percutaneous Coronary Intervention | Coronary Artery Bypass Surgery | Cardiac Resynchronization Therapy
Item
1. acute coronary syndrome, revascularization (pci or cabg), or cardiac resynchronization during the last 3 months
boolean
C0948089 (UMLS CUI [1])
C0581603 (UMLS CUI [2])
C1532338 (UMLS CUI [3])
C0010055 (UMLS CUI [4])
C1167956 (UMLS CUI [5])
Sustained ventricular tachycardia
Item
2. sustained ventricular
boolean
C0750197 (UMLS CUI [1])
Revascularization Additional Planned
Item
3. further revascularization planned for the next 30 days.
boolean
C0581603 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C1301732 (UMLS CUI [1,3])
Chronic atrial fibrillation
Item
4. chronic atrial fibrillation.
boolean
C0694539 (UMLS CUI [1])
Target region Wall thickness Echocardiography | Other Coding
Item
5. a wall thickness in the target region <8 mm as determined by 2d echocardiography (the target region is defined at the time of noga® mapping).
boolean
C1521840 (UMLS CUI [1,1])
C0205147 (UMLS CUI [1,2])
C0442069 (UMLS CUI [1,3])
C1280412 (UMLS CUI [1,4])
C0013516 (UMLS CUI [1,5])
C3846158 (UMLS CUI [2])
Left ventricular thrombus
Item
6. an lv thrombus.
boolean
C0587044 (UMLS CUI [1])
Peripheral Vascular Disease Severe | Femoral artery Access Excluded | Catheterization
Item
7. severe peripheral vascular disease precluding femoral artery access as determined at time of original catheterization.
boolean
C0085096 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0015801 (UMLS CUI [2,1])
C0444454 (UMLS CUI [2,2])
C0332196 (UMLS CUI [2,3])
C0007430 (UMLS CUI [3])
Aortic Valve Stenosis | Catheter Access Left ventricle Excluded
Item
8. aortic stenosis as determined as valve area less than 1 cm2 that prohibits catheter access to the lv.
boolean
C0003507 (UMLS CUI [1])
C0441134 (UMLS CUI [2,1])
C0444454 (UMLS CUI [2,2])
C0225897 (UMLS CUI [2,3])
C0332196 (UMLS CUI [2,4])
HIV-1 | HIV-2 | Human T-lymphotropic virus 1 | Human T-lymphotropic virus 2
Item
9. human immunodeficiency virus (hiv1-2), htlv-1 and 2.
boolean
C0019704 (UMLS CUI [1])
C0019707 (UMLS CUI [2])
C0020094 (UMLS CUI [3])
C0020099 (UMLS CUI [4])
Communicable Disease Uncontrolled
Item
10. an active uncontrolled infection.
boolean
C0009450 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Aortic valve prosthesis
Item
11. a prosthetic aortic valve.
boolean
C0182431 (UMLS CUI [1])
Neoplasm | Exception Basal cell carcinoma
Item
12. a current or prior history within the last 3 years of neoplasm (excluding basal cell) and/or any active neoplasm within the last 24 months.
boolean
C0027651 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0007117 (UMLS CUI [2,2])
Pregnancy | Breast Feeding
Item
13. pregnancy or breastfeeding.
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
Investigational Therapy Repair cardiovascular | Investigational Therapy Regeneration Cardiovascular
Item
14. active participation in other research therapy for cardiovascular repair/regeneration.
boolean
C0949266 (UMLS CUI [1,1])
C0849442 (UMLS CUI [1,2])
C0949266 (UMLS CUI [2,1])
C0349676 (UMLS CUI [2,2])
C3887460 (UMLS CUI [2,3])
Medical condition Affecting Evaluation Patient condition | Medical condition compromises Patient safety
Item
15. any medical condition that would affect the investigator's ability to evaluate the subject's condition or could compromise the subject's safety.
boolean
C3843040 (UMLS CUI [1,1])
C0392760 (UMLS CUI [1,2])
C1261322 (UMLS CUI [1,3])
C0683521 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C1113679 (UMLS CUI [2,3])
Condition Study Subject Participation Status Excluded
Item
16. any condition that, in the judgment of the investigator, would prohibit the subject from participating in the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C2828389 (UMLS CUI [1,3])
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