ID

20307

Description

Rosiglitazone and Metformin: Outcomes Trial in Nondiabetic Patients With Stable Coronary Syndromes (Romance) Pilot Study; ODM derived from: https://clinicaltrials.gov/show/NCT00343395

Link

https://clinicaltrials.gov/show/NCT00343395

Keywords

Versions (1)
  1. 2/20/17 2/20/17 -
Uploaded on

February 20, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Artery Disease NCT00343395

English

Eligibility Coronary Artery Disease NCT00343395

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
the patient (male or non-pregnant female) must be > 18 years of age.
Description

Age | Pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0032961
the patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
Description

Informed Consent | Informed Consent Patient Representatives

Data type

boolean

Alias
UMLS CUI [1]
C0021430
UMLS CUI [2,1]
C0021430
UMLS CUI [2,2]
C0030701
angiographically documented coronary artery disease defined as the presence of at least one 50% or greater stenosis of a major coronary artery.
Description

Coronary Artery Disease angiography | Coronary artery Major Percent Diameter Stenosis Measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C0002978
UMLS CUI [2,1]
C0205042
UMLS CUI [2,2]
C0205164
UMLS CUI [2,3]
C3897965
stabilized post any prior acs event (i.e., without ongoing ischemic rest pain, congestive heart failure, or malignant arrhythmias) for at least 3 months
Description

Stabilization Post Acute Coronary Syndrome | Ischemic pain At rest | Congestive heart failure | Cardiac Arrhythmia Malignant

Data type

boolean

Alias
UMLS CUI [1,1]
C1293130
UMLS CUI [1,2]
C0687676
UMLS CUI [1,3]
C0948089
UMLS CUI [2,1]
C0745417
UMLS CUI [2,2]
C0443144
UMLS CUI [3]
C0018802
UMLS CUI [4,1]
C0003811
UMLS CUI [4,2]
C0205282
fasting blood glucose 87-125 mg/dl
Description

Fasting blood glucose measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428568
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
age <18 years
Description

Age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
known hypersensitivity to metformin or rosiglitazone
Description

Metformin allergy | Hypersensitivity rosiglitazone

Data type

boolean

Alias
UMLS CUI [1]
C0571648
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0289313
renal insufficiency defined as calculated creatinine clearance (crcl) <40 ml/min using the following formula:
Description

Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C2711451
men: crcl (ml/min) = weight (kg) x (140-age) 72 x serum creatinine (mg/dl) women: 0.85 x the value calculated for men
Description

Estimation of creatinine clearance by Cockcroft-Gault formula | Gender

Data type

boolean

Alias
UMLS CUI [1]
C2711451
UMLS CUI [2]
C0079399
pregnant and/or lactating women, and women of child bearing potential are excluded from this trial
Description

Pregnancy | Breast Feeding | Childbearing Potential

Data type

boolean

Alias
UMLS CUI [1]
C0032961
UMLS CUI [2]
C0006147
UMLS CUI [3]
C3831118
co-morbidity such that the patient is not expected to survive >2 years
Description

Comorbidity | Life Expectancy

Data type

boolean

Alias
UMLS CUI [1]
C0009488
UMLS CUI [2]
C0023671
current therapy with rosiglitazone or metformin
Description

rosiglitazone | Metformin

Data type

boolean

Alias
UMLS CUI [1]
C0289313
UMLS CUI [2]
C0025598
pci within the previous six months (other than for the qualifying event)
Description

Percutaneous Coronary Intervention

Data type

boolean

Alias
UMLS CUI [1]
C1532338
prior cabg within the previous two months, scheduled cabg, or a decision to perform cabg made prior to enrollment
Description

Coronary Artery Bypass Surgery | Coronary Artery Bypass Surgery Scheduled | Coronary Artery Bypass Surgery Perform Decision

Data type

boolean

Alias
UMLS CUI [1]
C0010055
UMLS CUI [2,1]
C0010055
UMLS CUI [2,2]
C0205539
UMLS CUI [3,1]
C0010055
UMLS CUI [3,2]
C0884358
UMLS CUI [3,3]
C0679006
overt diabetes mellitus (fbg>126 or antidiabetic therapy)
Description

Diabetes Mellitus | Fasting blood glucose measurement | Antidiabetics

Data type

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0428568
UMLS CUI [3]
C0935929
any diagnosis of congestive heart failure
Description

Congestive heart failure

Data type

boolean

Alias
UMLS CUI [1]
C0018802
obstructive hepatobiliary disease or other significant hepatic disease (defined as the presence of at least one of the following: ast, alt, ggt, total bilirubin, or alkaline phosphatase >3x upper limit normal, not related to mi
Description

Hepatobiliary disease Obstructive | Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Elevated total bilirubin | Alkaline phosphatase raised | Myocardial Infarction Relationship Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0267792
UMLS CUI [1,2]
C0549186
UMLS CUI [2]
C0023895
UMLS CUI [3]
C0151904
UMLS CUI [4]
C0151905
UMLS CUI [5]
C0151662
UMLS CUI [6]
C0741494
UMLS CUI [7]
C0151849
UMLS CUI [8,1]
C0027051
UMLS CUI [8,2]
C0439849
UMLS CUI [8,3]
C0332197
participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
Description

Study Subject Participation Status | Investigational New Drugs | product marketing

Data type

boolean

Alias
UMLS CUI [1]
C2348568
UMLS CUI [2]
C0013230
UMLS CUI [3]
C0683746
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Similar models

Eligibility Coronary Artery Disease NCT00343395

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Age | Pregnancy
Item
the patient (male or non-pregnant female) must be > 18 years of age.
boolean
C0001779 (UMLS CUI [1])
C0032961 (UMLS CUI [2])
Informed Consent | Informed Consent Patient Representatives
Item
the patient or legally authorized representative must sign a written informed consent, prior to the procedure, using a form that is approved by the local institutional review board.
boolean
C0021430 (UMLS CUI [1])
C0021430 (UMLS CUI [2,1])
C0030701 (UMLS CUI [2,2])
Coronary Artery Disease angiography | Coronary artery Major Percent Diameter Stenosis Measurement
Item
angiographically documented coronary artery disease defined as the presence of at least one 50% or greater stenosis of a major coronary artery.
boolean
C1956346 (UMLS CUI [1,1])
C0002978 (UMLS CUI [1,2])
C0205042 (UMLS CUI [2,1])
C0205164 (UMLS CUI [2,2])
C3897965 (UMLS CUI [2,3])
Stabilization Post Acute Coronary Syndrome | Ischemic pain At rest | Congestive heart failure | Cardiac Arrhythmia Malignant
Item
stabilized post any prior acs event (i.e., without ongoing ischemic rest pain, congestive heart failure, or malignant arrhythmias) for at least 3 months
boolean
C1293130 (UMLS CUI [1,1])
C0687676 (UMLS CUI [1,2])
C0948089 (UMLS CUI [1,3])
C0745417 (UMLS CUI [2,1])
C0443144 (UMLS CUI [2,2])
C0018802 (UMLS CUI [3])
C0003811 (UMLS CUI [4,1])
C0205282 (UMLS CUI [4,2])
Fasting blood glucose measurement
Item
fasting blood glucose 87-125 mg/dl
boolean
C0428568 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
Age
Item
age <18 years
boolean
C0001779 (UMLS CUI [1])
Metformin allergy | Hypersensitivity rosiglitazone
Item
known hypersensitivity to metformin or rosiglitazone
boolean
C0571648 (UMLS CUI [1])
C0020517 (UMLS CUI [2,1])
C0289313 (UMLS CUI [2,2])
Renal Insufficiency | Estimation of creatinine clearance by Cockcroft-Gault formula
Item
renal insufficiency defined as calculated creatinine clearance (crcl) <40 ml/min using the following formula:
boolean
C1565489 (UMLS CUI [1])
C2711451 (UMLS CUI [2])
Estimation of creatinine clearance by Cockcroft-Gault formula | Gender
Item
men: crcl (ml/min) = weight (kg) x (140-age) 72 x serum creatinine (mg/dl) women: 0.85 x the value calculated for men
boolean
C2711451 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
Pregnancy | Breast Feeding | Childbearing Potential
Item
pregnant and/or lactating women, and women of child bearing potential are excluded from this trial
boolean
C0032961 (UMLS CUI [1])
C0006147 (UMLS CUI [2])
C3831118 (UMLS CUI [3])
Comorbidity | Life Expectancy
Item
co-morbidity such that the patient is not expected to survive >2 years
boolean
C0009488 (UMLS CUI [1])
C0023671 (UMLS CUI [2])
rosiglitazone | Metformin
Item
current therapy with rosiglitazone or metformin
boolean
C0289313 (UMLS CUI [1])
C0025598 (UMLS CUI [2])
Percutaneous Coronary Intervention
Item
pci within the previous six months (other than for the qualifying event)
boolean
C1532338 (UMLS CUI [1])
Coronary Artery Bypass Surgery | Coronary Artery Bypass Surgery Scheduled | Coronary Artery Bypass Surgery Perform Decision
Item
prior cabg within the previous two months, scheduled cabg, or a decision to perform cabg made prior to enrollment
boolean
C0010055 (UMLS CUI [1])
C0010055 (UMLS CUI [2,1])
C0205539 (UMLS CUI [2,2])
C0010055 (UMLS CUI [3,1])
C0884358 (UMLS CUI [3,2])
C0679006 (UMLS CUI [3,3])
Diabetes Mellitus | Fasting blood glucose measurement | Antidiabetics
Item
overt diabetes mellitus (fbg>126 or antidiabetic therapy)
boolean
C0011849 (UMLS CUI [1])
C0428568 (UMLS CUI [2])
C0935929 (UMLS CUI [3])
Congestive heart failure
Item
any diagnosis of congestive heart failure
boolean
C0018802 (UMLS CUI [1])
Hepatobiliary disease Obstructive | Liver disease | Aspartate aminotransferase increased | Alanine aminotransferase increased | Gamma-glutamyl transferase raised | Elevated total bilirubin | Alkaline phosphatase raised | Myocardial Infarction Relationship Absent
Item
obstructive hepatobiliary disease or other significant hepatic disease (defined as the presence of at least one of the following: ast, alt, ggt, total bilirubin, or alkaline phosphatase >3x upper limit normal, not related to mi
boolean
C0267792 (UMLS CUI [1,1])
C0549186 (UMLS CUI [1,2])
C0023895 (UMLS CUI [2])
C0151904 (UMLS CUI [3])
C0151905 (UMLS CUI [4])
C0151662 (UMLS CUI [5])
C0741494 (UMLS CUI [6])
C0151849 (UMLS CUI [7])
C0027051 (UMLS CUI [8,1])
C0439849 (UMLS CUI [8,2])
C0332197 (UMLS CUI [8,3])
Study Subject Participation Status | Investigational New Drugs | product marketing
Item
participation in any other clinical trials involving investigational or marketed products within 30 days prior to entry in the study.
boolean
C2348568 (UMLS CUI [1])
C0013230 (UMLS CUI [2])
C0683746 (UMLS CUI [3])
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