ID

40489

Beschreibung

Copenhagen Study of Obese Patients With Ischemic Heart Disease Undergoing Low Energy Diet or Interval Training; ODM derived from: https://clinicaltrials.gov/show/NCT01724567

Link

https://clinicaltrials.gov/show/NCT01724567

Stichworte

Versionen (1)
  1. 25.04.20 25.04.20 -
Rechteinhaber

See clinicaltrials.gov

Hochgeladen am

25. April 2020

DOI

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Lizenz

Creative Commons BY 4.0
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Eligibility Ischemic Heart Disease NCT01724567

Englisch

Eligibility Ischemic Heart Disease NCT01724567

1 Formulare  
Inclusion Criteria
Beschreibung

Inclusion Criteria

Alias
UMLS CUI
C1512693
stable ischemic heart disease
Beschreibung

Myocardial Ischemia Stable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0151744
UMLS CUI [1,2]
C0205360
bmi 28 - 40 kg/m2
Beschreibung

Body mass index

Datentyp

boolean

Alias
UMLS CUI [1]
C1305855
Exclusion Criteria
Beschreibung

Exclusion Criteria

Alias
UMLS CUI
C0680251
known diabetes mellitus
Beschreibung

Diabetes Mellitus

Datentyp

boolean

Alias
UMLS CUI [1]
C0011849
repeated fasting plasma glucose ≥ 7 mmol/l or hba1c > 7 %
Beschreibung

Plasma fasting glucose measurement | Hemoglobin A1c measurement

Datentyp

boolean

Alias
UMLS CUI [1]
C0583513
UMLS CUI [2]
C0474680
severe or moderate valve disease
Beschreibung

Valvular disease Severe | Valvular disease Moderate

Datentyp

boolean

Alias
UMLS CUI [1,1]
C3258293
UMLS CUI [1,2]
C0205082
UMLS CUI [2,1]
C3258293
UMLS CUI [2,2]
C0205081
main stem stenosis
Beschreibung

Coronary Artery Stenosis Main

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0242231
UMLS CUI [1,2]
C1542147
severe heart failure, ejection fraction < 35 %
Beschreibung

Heart failure Severe | Cardiac ejection fraction

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0018801
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0232174
physical or mental disability which are expected to prevent completion of intervention
Beschreibung

Physical disability Preventing Intervention | Mental handicap Preventing Intervention

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0520817
UMLS CUI [1,2]
C1292733
UMLS CUI [1,3]
C0184661
UMLS CUI [2,1]
C1306341
UMLS CUI [2,2]
C1292733
UMLS CUI [2,3]
C0184661
severe chronic obstructive pulmonary disease (copd) (fev1 < 50 % of expected) or asthma
Beschreibung

Severe chronic obstructive pulmonary disease | Percent predicted FEV1 | Asthma

Datentyp

boolean

Alias
UMLS CUI [1]
C0730607
UMLS CUI [2]
C0730561
UMLS CUI [3]
C0004096
active cancer
Beschreibung

Malignant Neoplasms

Datentyp

boolean

Alias
UMLS CUI [1]
C0006826
severe kidney (gfr < 40 ml/hour) or severe liver disease
Beschreibung

Kidney Disease Severe | Glomerular Filtration Rate | Liver disease Severe

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022658
UMLS CUI [1,2]
C0205082
UMLS CUI [2]
C0017654
UMLS CUI [3,1]
C0023895
UMLS CUI [3,2]
C0205082
severe ischemia or arrhythmias during exercise test
Beschreibung

Ischemia Severe During Exercise test | Cardiac Arrhythmia Severe During Exercise test

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0022116
UMLS CUI [1,2]
C0205082
UMLS CUI [1,3]
C0347984
UMLS CUI [1,4]
C0015260
UMLS CUI [2,1]
C0003811
UMLS CUI [2,2]
C0205082
UMLS CUI [2,3]
C0347984
UMLS CUI [2,4]
C0015260
2. or 3. degree atrio-ventricular (av) block, not protected by pacemaker
Beschreibung

Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent

Datentyp

boolean

Alias
UMLS CUI [1]
C0264906
UMLS CUI [2]
C0151517
UMLS CUI [3,1]
C0030163
UMLS CUI [3,2]
C0332197
organised training more than 2 times a week prior to inclusion
Beschreibung

Exercise times/week

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0015259
UMLS CUI [1,2]
C0456698
significant weight loss or weight gain (> 5 %)3 month prior to inclusion
Beschreibung

Weight loss Percentage Timespan | Weight Gain Percentage Timespan

Datentyp

boolean

Alias
UMLS CUI [1,1]
C1262477
UMLS CUI [1,2]
C0439165
UMLS CUI [1,3]
C0872291
UMLS CUI [2,1]
C0043094
UMLS CUI [2,2]
C0439165
UMLS CUI [2,3]
C0872291
not able to comprehend written and oral informed consent
Beschreibung

Informed Consent Comprehension Unable

Datentyp

boolean

Alias
UMLS CUI [1,1]
C0021430
UMLS CUI [1,2]
C0162340
UMLS CUI [1,3]
C1299582
hormone treatment
Beschreibung

Hormone Therapy

Datentyp

boolean

Alias
UMLS CUI [1]
C0279025
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Ähnliche Modelle

Eligibility Ischemic Heart Disease NCT01724567

1 Formulare
Name
Typ
Description | Question | Decode (Coded Value)
Datentyp
Alias
Item Group
C1512693 (UMLS CUI)
Myocardial Ischemia Stable
Item
stable ischemic heart disease
boolean
C0151744 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
Body mass index
Item
bmi 28 - 40 kg/m2
boolean
C1305855 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Diabetes Mellitus
Item
known diabetes mellitus
boolean
C0011849 (UMLS CUI [1])
Plasma fasting glucose measurement | Hemoglobin A1c measurement
Item
repeated fasting plasma glucose ≥ 7 mmol/l or hba1c > 7 %
boolean
C0583513 (UMLS CUI [1])
C0474680 (UMLS CUI [2])
Valvular disease Severe | Valvular disease Moderate
Item
severe or moderate valve disease
boolean
C3258293 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C3258293 (UMLS CUI [2,1])
C0205081 (UMLS CUI [2,2])
Coronary Artery Stenosis Main
Item
main stem stenosis
boolean
C0242231 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Heart failure Severe | Cardiac ejection fraction
Item
severe heart failure, ejection fraction < 35 %
boolean
C0018801 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0232174 (UMLS CUI [2])
Physical disability Preventing Intervention | Mental handicap Preventing Intervention
Item
physical or mental disability which are expected to prevent completion of intervention
boolean
C0520817 (UMLS CUI [1,1])
C1292733 (UMLS CUI [1,2])
C0184661 (UMLS CUI [1,3])
C1306341 (UMLS CUI [2,1])
C1292733 (UMLS CUI [2,2])
C0184661 (UMLS CUI [2,3])
Severe chronic obstructive pulmonary disease | Percent predicted FEV1 | Asthma
Item
severe chronic obstructive pulmonary disease (copd) (fev1 < 50 % of expected) or asthma
boolean
C0730607 (UMLS CUI [1])
C0730561 (UMLS CUI [2])
C0004096 (UMLS CUI [3])
Malignant Neoplasms
Item
active cancer
boolean
C0006826 (UMLS CUI [1])
Kidney Disease Severe | Glomerular Filtration Rate | Liver disease Severe
Item
severe kidney (gfr < 40 ml/hour) or severe liver disease
boolean
C0022658 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0017654 (UMLS CUI [2])
C0023895 (UMLS CUI [3,1])
C0205082 (UMLS CUI [3,2])
Ischemia Severe During Exercise test | Cardiac Arrhythmia Severe During Exercise test
Item
severe ischemia or arrhythmias during exercise test
boolean
C0022116 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
C0347984 (UMLS CUI [1,3])
C0015260 (UMLS CUI [1,4])
C0003811 (UMLS CUI [2,1])
C0205082 (UMLS CUI [2,2])
C0347984 (UMLS CUI [2,3])
C0015260 (UMLS CUI [2,4])
Second degree atrioventricular block | Complete atrioventricular block | Artificial cardiac pacemaker Absent
Item
2. or 3. degree atrio-ventricular (av) block, not protected by pacemaker
boolean
C0264906 (UMLS CUI [1])
C0151517 (UMLS CUI [2])
C0030163 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
Exercise times/week
Item
organised training more than 2 times a week prior to inclusion
boolean
C0015259 (UMLS CUI [1,1])
C0456698 (UMLS CUI [1,2])
Weight loss Percentage Timespan | Weight Gain Percentage Timespan
Item
significant weight loss or weight gain (> 5 %)3 month prior to inclusion
boolean
C1262477 (UMLS CUI [1,1])
C0439165 (UMLS CUI [1,2])
C0872291 (UMLS CUI [1,3])
C0043094 (UMLS CUI [2,1])
C0439165 (UMLS CUI [2,2])
C0872291 (UMLS CUI [2,3])
Informed Consent Comprehension Unable
Item
not able to comprehend written and oral informed consent
boolean
C0021430 (UMLS CUI [1,1])
C0162340 (UMLS CUI [1,2])
C1299582 (UMLS CUI [1,3])
Hormone Therapy
Item
hormone treatment
boolean
C0279025 (UMLS CUI [1])
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