ID

44423

Description

The Cardiac Benefit of Testosterone Replacement in Men With Low Testosterone Levels With Coronary Artery Disease After Successful Intervention of the Blockage or Narrowed Heart Artery; ODM derived from: https://clinicaltrials.gov/show/NCT00413244

Link

https://clinicaltrials.gov/show/NCT00413244

Keywords

Versions (2)
  1. 1/13/18 1/13/18 -
  2. 9/20/21 9/20/21 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

September 20, 2021

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00413244

English

Eligibility Coronary Artery Disease NCT00413244

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
adult male patients with coronary artery disease (cad) (one to three vessel diseased).
Description

Adult | Gender | Coronary Artery Disease | Number of Diseased Coronary Artery Vessels

Data type

boolean

Alias
UMLS CUI [1]
C0001675
UMLS CUI [2]
C0079399
UMLS CUI [3]
C1956346
UMLS CUI [4]
C3275120
stable cardiac status at least 3 months after percutaneous coronary intervention (pci).
Description

Cardiac Status Stable | Status post Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1,1]
C1999091
UMLS CUI [1,2]
C0205360
UMLS CUI [2,1]
C0231290
UMLS CUI [2,2]
C1532338
no change in cardiac medications for 4 weeks prior to enrollment.
Description

Pharmaceutical Preparations cardiac unchanged

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0018787
UMLS CUI [1,3]
C0442739
testosterone < 300 ng/dl or free testosterone < 5.0 ng/dl or bioavailable testosterone < 150 ng/dl.
Description

Testosterone measurement | Free Testosterone Measurement | Bioavailable testosterone

Data type

boolean

Alias
UMLS CUI [1]
C0523912
UMLS CUI [2]
C0202228
UMLS CUI [3]
C0370051
sex hormone binding globulin (shbg) < 7nmol/liter and free testosterone < 50pg/dl
Description

Sex hormone binding globulin measurement | Free Testosterone Measurement

Data type

boolean

Alias
UMLS CUI [1]
C0202218
UMLS CUI [2]
C0202228
prostate specific antigen (psa) < 2.5 ng/ml or 2.6-3.7ng/ml with a negative prostate biopsy within the last 6 months and pathology report available for investigator's review.
Description

Prostate specific antigen measurement | Biopsy of prostate Negative | Pathology report Available

Data type

boolean

Alias
UMLS CUI [1]
C0201544
UMLS CUI [2,1]
C0194804
UMLS CUI [2,2]
C1513916
UMLS CUI [3,1]
C0807321
UMLS CUI [3,2]
C0470187
subgroup of diabetics with well to moderately controlled diabetes (defined by a hgba1c of < 9mg/dl.
Description

Subgroup Patients Diabetic | Diabetes Mellitus Well controlled | Diabetes Mellitus Controlled Moderate | Glucohemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1515021
UMLS CUI [1,2]
C0030705
UMLS CUI [1,3]
C0241863
UMLS CUI [2,1]
C0011849
UMLS CUI [2,2]
C3853142
UMLS CUI [3,1]
C0011849
UMLS CUI [3,2]
C2587213
UMLS CUI [3,3]
C0205081
UMLS CUI [4]
C0202054
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
hematocrit greater than 50%.
Description

Hematocrit procedure

Data type

boolean

Alias
UMLS CUI [1]
C0018935
severe hypertension (exhibit systolic blood pressure >180mmhg and diastolic blood pressure >110 mmhg at baseline visit or a have a history of malignant hypertension.
Description

Hypertension, severe | Systolic Pressure | Diastolic blood pressure | Malignant Hypertension

Data type

boolean

Alias
UMLS CUI [1]
C4013784
UMLS CUI [2]
C0871470
UMLS CUI [3]
C0428883
UMLS CUI [4]
C0020540
significant cardiac arrhythmia (supraventricular tachycardia [svt] or ventricular tachycardia with heart rate exceeding 110 beats per minute at visit 1).
Description

Cardiac Arrhythmia | Supraventricular tachycardia | Tachycardia, Ventricular | Heart rate Beats per minute

Data type

boolean

Alias
UMLS CUI [1]
C0003811
UMLS CUI [2]
C0039240
UMLS CUI [3]
C0042514
UMLS CUI [4,1]
C0018810
UMLS CUI [4,2]
C0439385
ecg abnormalities precluding st segment analysis on treadmill, or inability to walk on treadmill.
Description

ECG abnormality | Exclusion ST segment Analysis Treadmill | Lacking Able to walk Treadmill

Data type

boolean

Alias
UMLS CUI [1]
C0522055
UMLS CUI [2,1]
C2828389
UMLS CUI [2,2]
C0429029
UMLS CUI [2,3]
C0936012
UMLS CUI [2,4]
C0184069
UMLS CUI [3,1]
C0332268
UMLS CUI [3,2]
C2712089
UMLS CUI [3,3]
C0184069
poorly controlled, symptomatic, active medical problems (hiv, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder).
Description

Medical Problem Symptomatic Poorly controlled | HIV Infection | Hepatitis | Malignant Neoplasms | Benign prostatic hypertrophy | Substance Use Disorders | Major Depressive Disorder

Data type

boolean

Alias
UMLS CUI [1,1]
C1254481
UMLS CUI [1,2]
C0231220
UMLS CUI [1,3]
C3853134
UMLS CUI [2]
C0019693
UMLS CUI [3]
C0019158
UMLS CUI [4]
C0006826
UMLS CUI [5]
C1704272
UMLS CUI [6]
C0038586
UMLS CUI [7]
C1269683
neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
Description

Nervous system disorder compromises Informed Consent | Nervous system disorder compromises Protocol Compliance | Mental disorders compromise Informed Consent | Mental disorders compromise Protocol Compliance

Data type

boolean

Alias
UMLS CUI [1,1]
C0027765
UMLS CUI [1,2]
C2945640
UMLS CUI [1,3]
C0021430
UMLS CUI [2,1]
C0027765
UMLS CUI [2,2]
C2945640
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0004936
UMLS CUI [3,2]
C2945640
UMLS CUI [3,3]
C0021430
UMLS CUI [4,1]
C0004936
UMLS CUI [4,2]
C2945640
UMLS CUI [4,3]
C0525058
history of prostate cancer
Description

Prostate carcinoma

Data type

boolean

Alias
UMLS CUI [1]
C0600139
history of hypersensitivity to transdermal testosterone gel.
Description

Hypersensitivity Testosterone Transdermal Product

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C3466313
international prostate symptom score (ipss) >19 at visit 1.
Description

International prostate symptom score

Data type

boolean

Alias
UMLS CUI [1]
C1998280
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Similar models

Eligibility Coronary Artery Disease NCT00413244

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Adult | Gender | Coronary Artery Disease | Number of Diseased Coronary Artery Vessels
Item
adult male patients with coronary artery disease (cad) (one to three vessel diseased).
boolean
C0001675 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
C1956346 (UMLS CUI [3])
C3275120 (UMLS CUI [4])
Cardiac Status Stable | Status post Percutaneous Coronary Intervention
Item
stable cardiac status at least 3 months after percutaneous coronary intervention (pci).
boolean
C1999091 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0231290 (UMLS CUI [2,1])
C1532338 (UMLS CUI [2,2])
Pharmaceutical Preparations cardiac unchanged
Item
no change in cardiac medications for 4 weeks prior to enrollment.
boolean
C0013227 (UMLS CUI [1,1])
C0018787 (UMLS CUI [1,2])
C0442739 (UMLS CUI [1,3])
Testosterone measurement | Free Testosterone Measurement | Bioavailable testosterone
Item
testosterone < 300 ng/dl or free testosterone < 5.0 ng/dl or bioavailable testosterone < 150 ng/dl.
boolean
C0523912 (UMLS CUI [1])
C0202228 (UMLS CUI [2])
C0370051 (UMLS CUI [3])
Sex hormone binding globulin measurement | Free Testosterone Measurement
Item
sex hormone binding globulin (shbg) < 7nmol/liter and free testosterone < 50pg/dl
boolean
C0202218 (UMLS CUI [1])
C0202228 (UMLS CUI [2])
Prostate specific antigen measurement | Biopsy of prostate Negative | Pathology report Available
Item
prostate specific antigen (psa) < 2.5 ng/ml or 2.6-3.7ng/ml with a negative prostate biopsy within the last 6 months and pathology report available for investigator's review.
boolean
C0201544 (UMLS CUI [1])
C0194804 (UMLS CUI [2,1])
C1513916 (UMLS CUI [2,2])
C0807321 (UMLS CUI [3,1])
C0470187 (UMLS CUI [3,2])
Subgroup Patients Diabetic | Diabetes Mellitus Well controlled | Diabetes Mellitus Controlled Moderate | Glucohemoglobin measurement
Item
subgroup of diabetics with well to moderately controlled diabetes (defined by a hgba1c of < 9mg/dl.
boolean
C1515021 (UMLS CUI [1,1])
C0030705 (UMLS CUI [1,2])
C0241863 (UMLS CUI [1,3])
C0011849 (UMLS CUI [2,1])
C3853142 (UMLS CUI [2,2])
C0011849 (UMLS CUI [3,1])
C2587213 (UMLS CUI [3,2])
C0205081 (UMLS CUI [3,3])
C0202054 (UMLS CUI [4])
Item Group
C0680251 (UMLS CUI)
Hematocrit procedure
Item
hematocrit greater than 50%.
boolean
C0018935 (UMLS CUI [1])
Hypertension, severe | Systolic Pressure | Diastolic blood pressure | Malignant Hypertension
Item
severe hypertension (exhibit systolic blood pressure >180mmhg and diastolic blood pressure >110 mmhg at baseline visit or a have a history of malignant hypertension.
boolean
C4013784 (UMLS CUI [1])
C0871470 (UMLS CUI [2])
C0428883 (UMLS CUI [3])
C0020540 (UMLS CUI [4])
Cardiac Arrhythmia | Supraventricular tachycardia | Tachycardia, Ventricular | Heart rate Beats per minute
Item
significant cardiac arrhythmia (supraventricular tachycardia [svt] or ventricular tachycardia with heart rate exceeding 110 beats per minute at visit 1).
boolean
C0003811 (UMLS CUI [1])
C0039240 (UMLS CUI [2])
C0042514 (UMLS CUI [3])
C0018810 (UMLS CUI [4,1])
C0439385 (UMLS CUI [4,2])
ECG abnormality | Exclusion ST segment Analysis Treadmill | Lacking Able to walk Treadmill
Item
ecg abnormalities precluding st segment analysis on treadmill, or inability to walk on treadmill.
boolean
C0522055 (UMLS CUI [1])
C2828389 (UMLS CUI [2,1])
C0429029 (UMLS CUI [2,2])
C0936012 (UMLS CUI [2,3])
C0184069 (UMLS CUI [2,4])
C0332268 (UMLS CUI [3,1])
C2712089 (UMLS CUI [3,2])
C0184069 (UMLS CUI [3,3])
Medical Problem Symptomatic Poorly controlled | HIV Infection | Hepatitis | Malignant Neoplasms | Benign prostatic hypertrophy | Substance Use Disorders | Major Depressive Disorder
Item
poorly controlled, symptomatic, active medical problems (hiv, hepatitis, cancer, benign prostatic hypertrophy, alcohol or drug abuse, major depressive disorder).
boolean
C1254481 (UMLS CUI [1,1])
C0231220 (UMLS CUI [1,2])
C3853134 (UMLS CUI [1,3])
C0019693 (UMLS CUI [2])
C0019158 (UMLS CUI [3])
C0006826 (UMLS CUI [4])
C1704272 (UMLS CUI [5])
C0038586 (UMLS CUI [6])
C1269683 (UMLS CUI [7])
Nervous system disorder compromises Informed Consent | Nervous system disorder compromises Protocol Compliance | Mental disorders compromise Informed Consent | Mental disorders compromise Protocol Compliance
Item
neurological or psychiatric disorder that would compromise the patient's ability to give informed consent or adhere to the requirements of the protocol.
boolean
C0027765 (UMLS CUI [1,1])
C2945640 (UMLS CUI [1,2])
C0021430 (UMLS CUI [1,3])
C0027765 (UMLS CUI [2,1])
C2945640 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0004936 (UMLS CUI [3,1])
C2945640 (UMLS CUI [3,2])
C0021430 (UMLS CUI [3,3])
C0004936 (UMLS CUI [4,1])
C2945640 (UMLS CUI [4,2])
C0525058 (UMLS CUI [4,3])
Prostate carcinoma
Item
history of prostate cancer
boolean
C0600139 (UMLS CUI [1])
Hypersensitivity Testosterone Transdermal Product
Item
history of hypersensitivity to transdermal testosterone gel.
boolean
C0020517 (UMLS CUI [1,1])
C3466313 (UMLS CUI [1,2])
International prostate symptom score
Item
international prostate symptom score (ipss) >19 at visit 1.
boolean
C1998280 (UMLS CUI [1])
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