ID

39393

Description

Paracrine Mechanisms of Bone Marrow Stem Cell Signalling in Chronic Heart Failure; ODM derived from: https://clinicaltrials.gov/show/NCT01086787

Lien

https://clinicaltrials.gov/show/NCT01086787

Mots-clés

Versions (1)
  1. 07/01/2020 07/01/2020 -
Détendeur de droits

See clinicaltrials.gov

Téléchargé le

7 janvier 2020

DOI

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Licence

Creative Commons BY 4.0
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Eligibility Heart Failure NCT01086787

Anglais

Eligibility Heart Failure NCT01086787

1 Formulaires  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
for all participants:
Description

Study Subject All

Type de données

boolean

Alias
UMLS CUI [1,1]
C0681850
UMLS CUI [1,2]
C0444868
1. before any study-specific procedures, the appropriate written informed consent must be obtained.
Description

Informed Consent

Type de données

boolean

Alias
UMLS CUI [1]
C0021430
2. male and female older than 18 years of age.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
for the cardiac patients:
Description

Patients cardiac

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C0018787
3. being accepted for cardiothoracic surgery with the use of open chest surgery
Description

Patients Accepted Cardiothoracic surgery | Thoracic Surgical Procedures

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1272684
UMLS CUI [1,3]
C2242990
UMLS CUI [2]
C0524832
4. a known left ventricular ejection fraction, either assessed by echocardiography, muga or mri. if lvef <40% a subject will be assigned to the chronic heart failure group, if lvef >40% a subject will be assigned to the control group.
Description

Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction MRI

Type de données

boolean

Alias
UMLS CUI [1,1]
C0428772
UMLS CUI [1,2]
C0013516
UMLS CUI [2,1]
C0428772
UMLS CUI [2,2]
C0521317
UMLS CUI [3,1]
C0428772
UMLS CUI [3,2]
C0024485
for the non-cardiac patients:
Description

Patients | Heart Disease Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0030705
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
5. accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.
Description

Patients Accepted Orthopedic Surgical Procedures | Total Hip Replacement

Type de données

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1272684
UMLS CUI [1,3]
C1136201
UMLS CUI [2]
C0040508
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. an unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
Description

Medical condition Unstable | Hospitalization Except Heart Disease | At risk Complication | At risk Adverse event

Type de données

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0443343
UMLS CUI [2,1]
C0019993
UMLS CUI [2,2]
C0332300
UMLS CUI [2,3]
C0018799
UMLS CUI [3,1]
C1444641
UMLS CUI [3,2]
C0009566
UMLS CUI [4,1]
C1444641
UMLS CUI [4,2]
C0877248
2. younger than 18 years of age.
Description

Age

Type de données

boolean

Alias
UMLS CUI [1]
C0001779
3. clinical history of chronic kidney disease (at any point prior to registration).
Description

Chronic Kidney Diseases

Type de données

boolean

Alias
UMLS CUI [1]
C1561643
4. any known hepatic disease.
Description

Liver disease

Type de données

boolean

Alias
UMLS CUI [1]
C0023895
5. recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
Description

Alcohol abuse | DRUG ABUSE ILLICIT

Type de données

boolean

Alias
UMLS CUI [1]
C0085762
UMLS CUI [2]
C0743253
6. clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
Description

Chemistry abnormal | Hematology finding abnormal | Urinalysis Parameters Abnormal

Type de données

boolean

Alias
UMLS CUI [1]
C0740327
UMLS CUI [2]
C0475182
UMLS CUI [3,1]
C0042014
UMLS CUI [3,2]
C0449381
UMLS CUI [3,3]
C0205161
7. participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
Description

Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs

Type de données

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C2346570
UMLS CUI [3]
C0013230
8. any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
Description

Condition Study Subject Participation Status At risk | Condition Interferes with Research results | Condition Interferes with Study Subject Participation Status | Mental disorder Study Subject Participation Status At risk | Mental disorder Interferes with Research results | Mental disorder Interferes with Study Subject Participation Status | Social situation Study Subject Participation Status At risk | Social situation Interferes with Research results | Social situation Interferes with Study Subject Participation Status

Type de données

boolean

Alias
UMLS CUI [1,1]
C0348080
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C1444641
UMLS CUI [2,1]
C0348080
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0683954
UMLS CUI [3,1]
C0348080
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C2348568
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C2348568
UMLS CUI [4,3]
C1444641
UMLS CUI [5,1]
C0004936
UMLS CUI [5,2]
C0521102
UMLS CUI [5,3]
C0683954
UMLS CUI [6,1]
C0004936
UMLS CUI [6,2]
C0521102
UMLS CUI [6,3]
C2348568
UMLS CUI [7,1]
C0748872
UMLS CUI [7,2]
C2348568
UMLS CUI [7,3]
C1444641
UMLS CUI [8,1]
C0748872
UMLS CUI [8,2]
C0521102
UMLS CUI [8,3]
C0683954
UMLS CUI [9,1]
C0748872
UMLS CUI [9,2]
C0521102
UMLS CUI [9,3]
C2348568
9. legally incompetent adults, for which reason what so ever.
Description

Adult Legal capacity Lacking

Type de données

boolean

Alias
UMLS CUI [1,1]
C0001675
UMLS CUI [1,2]
C0683673
UMLS CUI [1,3]
C0332268
for the non-cardiac patients:
Description

Patients | Heart Disease Absent

Type de données

boolean

Alias
UMLS CUI [1]
C0030705
UMLS CUI [2,1]
C0018799
UMLS CUI [2,2]
C0332197
10. a known history of cardiovascular disease.
Description

Cardiovascular Disease

Type de données

boolean

Alias
UMLS CUI [1]
C0007222
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Similar models

Eligibility Heart Failure NCT01086787

1 Formulaires
Name
Type
Description | Question | Decode (Coded Value)
Type de données
Alias
Item Group
C1512693 (UMLS CUI)
Study Subject All
Item
for all participants:
boolean
C0681850 (UMLS CUI [1,1])
C0444868 (UMLS CUI [1,2])
Informed Consent
Item
1. before any study-specific procedures, the appropriate written informed consent must be obtained.
boolean
C0021430 (UMLS CUI [1])
Age
Item
2. male and female older than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Patients cardiac
Item
for the cardiac patients:
boolean
C0030705 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
Patients Accepted Cardiothoracic surgery | Thoracic Surgical Procedures
Item
3. being accepted for cardiothoracic surgery with the use of open chest surgery
boolean
C0030705 (UMLS CUI [1,1])
C1272684 (UMLS CUI [1,2])
C2242990 (UMLS CUI [1,3])
C0524832 (UMLS CUI [2])
Left ventricular ejection fraction Echocardiography | Left ventricular ejection fraction MUGA scan | Left ventricular ejection fraction MRI
Item
4. a known left ventricular ejection fraction, either assessed by echocardiography, muga or mri. if lvef <40% a subject will be assigned to the chronic heart failure group, if lvef >40% a subject will be assigned to the control group.
boolean
C0428772 (UMLS CUI [1,1])
C0013516 (UMLS CUI [1,2])
C0428772 (UMLS CUI [2,1])
C0521317 (UMLS CUI [2,2])
C0428772 (UMLS CUI [3,1])
C0024485 (UMLS CUI [3,2])
Patients | Heart Disease Absent
Item
for the non-cardiac patients:
boolean
C0030705 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Patients Accepted Orthopedic Surgical Procedures | Total Hip Replacement
Item
5. accepted for orthopedic surgery (e.g. total hip replacement) at the department of orthopedic surgery.
boolean
C0030705 (UMLS CUI [1,1])
C1272684 (UMLS CUI [1,2])
C1136201 (UMLS CUI [1,3])
C0040508 (UMLS CUI [2])
Item Group
C0680251 (UMLS CUI)
Medical condition Unstable | Hospitalization Except Heart Disease | At risk Complication | At risk Adverse event
Item
1. an unstable medical condition, defined as having been hospitalized for a non-cardiac condition within 4 weeks of screening, or otherwise unstable in the judgment of the investigator (e.g. at risk of complications or adverse events unrelated to study participation).
boolean
C3843040 (UMLS CUI [1,1])
C0443343 (UMLS CUI [1,2])
C0019993 (UMLS CUI [2,1])
C0332300 (UMLS CUI [2,2])
C0018799 (UMLS CUI [2,3])
C1444641 (UMLS CUI [3,1])
C0009566 (UMLS CUI [3,2])
C1444641 (UMLS CUI [4,1])
C0877248 (UMLS CUI [4,2])
Age
Item
2. younger than 18 years of age.
boolean
C0001779 (UMLS CUI [1])
Chronic Kidney Diseases
Item
3. clinical history of chronic kidney disease (at any point prior to registration).
boolean
C1561643 (UMLS CUI [1])
Liver disease
Item
4. any known hepatic disease.
boolean
C0023895 (UMLS CUI [1])
Alcohol abuse | DRUG ABUSE ILLICIT
Item
5. recent (within 3 months) history of alcohol or illicit drug abuse disorder, based on self-report.
boolean
C0085762 (UMLS CUI [1])
C0743253 (UMLS CUI [2])
Chemistry abnormal | Hematology finding abnormal | Urinalysis Parameters Abnormal
Item
6. clinically significant abnormality in chemistry, hematology, or urinalysis parameters performed within the screening period.
boolean
C0740327 (UMLS CUI [1])
C0475182 (UMLS CUI [2])
C0042014 (UMLS CUI [3,1])
C0449381 (UMLS CUI [3,2])
C0205161 (UMLS CUI [3,3])
Study Subject Participation Status | Investigational Medical Device | Investigational New Drugs
Item
7. participation in any investigational device or drug trial(s) or receiving investigational agent(s) within 30 days.
boolean
C2348568 (UMLS CUI [1])
C2346570 (UMLS CUI [2])
C0013230 (UMLS CUI [3])
Condition Study Subject Participation Status At risk | Condition Interferes with Research results | Condition Interferes with Study Subject Participation Status | Mental disorder Study Subject Participation Status At risk | Mental disorder Interferes with Research results | Mental disorder Interferes with Study Subject Participation Status | Social situation Study Subject Participation Status At risk | Social situation Interferes with Research results | Social situation Interferes with Study Subject Participation Status
Item
8. any condition (e.g. psychiatric illness, etc.) or situation that, in the investigator's opinion, could put the subject at significant risk, confound the study results, or interfere significantly with the subject's participation in the study.
boolean
C0348080 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C1444641 (UMLS CUI [1,3])
C0348080 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0683954 (UMLS CUI [2,3])
C0348080 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C2348568 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C2348568 (UMLS CUI [4,2])
C1444641 (UMLS CUI [4,3])
C0004936 (UMLS CUI [5,1])
C0521102 (UMLS CUI [5,2])
C0683954 (UMLS CUI [5,3])
C0004936 (UMLS CUI [6,1])
C0521102 (UMLS CUI [6,2])
C2348568 (UMLS CUI [6,3])
C0748872 (UMLS CUI [7,1])
C2348568 (UMLS CUI [7,2])
C1444641 (UMLS CUI [7,3])
C0748872 (UMLS CUI [8,1])
C0521102 (UMLS CUI [8,2])
C0683954 (UMLS CUI [8,3])
C0748872 (UMLS CUI [9,1])
C0521102 (UMLS CUI [9,2])
C2348568 (UMLS CUI [9,3])
Adult Legal capacity Lacking
Item
9. legally incompetent adults, for which reason what so ever.
boolean
C0001675 (UMLS CUI [1,1])
C0683673 (UMLS CUI [1,2])
C0332268 (UMLS CUI [1,3])
Patients | Heart Disease Absent
Item
for the non-cardiac patients:
boolean
C0030705 (UMLS CUI [1])
C0018799 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Cardiovascular Disease
Item
10. a known history of cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
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