ID

20525

Description

Evaluate the Effectiveness and Cost of Stress Cardiac Magnetic Resonance Imaging (MRI) for Non-invasive Evaluation of Lesions Discovered on Computed Tomography Angiography (CCTA); ODM derived from: https://clinicaltrials.gov/show/NCT00538460

Link

https://clinicaltrials.gov/show/NCT00538460

Keywords

Versions (1)
  1. 3/1/17 3/1/17 -
Uploaded on

March 1, 2017

DOI

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License

Creative Commons BY 4.0
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Eligibility Coronary Disease NCT00538460

English

Eligibility Coronary Disease NCT00538460

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
1. patients with chest pain or other symptoms suggestive of acute cardiac ischemia.
Description

chest pain or other symptoms suggestive of acute cardiac ischemia

Data type

boolean

Alias
UMLS CUI [1]
C0008031
UMLS CUI [2,1]
C0151744
UMLS CUI [2,2]
C1457887
2. low risk timi risk score (ie. ≤3)
Description

timi risk score

Data type

boolean

Alias
UMLS CUI [1]
C3272266
3. able to provide informed consent
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
4. age equal to or greater than 18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
1. electrocardiographic evidence of ischemia, including acute stemi (st elevation equal to or greater than 1mm in two or more leads), st segment depression and/or t wave inversion (not known to be old), or attending physician clinical decision for immediate invasive evaluation.
Description

ECG signs of myocardial ischaemia | ST segment elevation myocardial infarction | ST segment depression (finding) | ECG T wave inversion new | physicians evaluation

Data type

boolean

Alias
UMLS CUI [1]
C1141959
UMLS CUI [2]
C1536220
UMLS CUI [3]
C0520887
UMLS CUI [4]
C0743447
UMLS CUI [5]
C2066348
2. positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase mb fraction).
Description

Cardiac biomarkers; Troponin measurement; Myoglobin measurement; Creatine kinase MB measurement

Data type

boolean

Alias
UMLS CUI [1,1]
C2735102
UMLS CUI [1,2]
C0523952
UMLS CUI [1,3]
C0373680
UMLS CUI [1,4]
C0523584
3. presence of pre-existing cad (prior myocardial infarction, prior angiographic evidence of significant cad, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
Description

Coronary Artery Disease; History of myocardial infarction; History of coronary artery bypass surgery (CABG); coronary angiography: coronary artery findings | Cardiomyopathies; Cardiac ejection fraction

Data type

boolean

Alias
UMLS CUI [1,1]
C1956346
UMLS CUI [1,2]
C1275835
UMLS CUI [1,3]
C1842251
UMLS CUI [1,4]
C2041526
UMLS CUI [2,1]
C0878544
UMLS CUI [2,2]
C0232174
4. renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
Description

creatinine, dialysis

Data type

boolean

Alias
UMLS CUI [1]
C0201976
UMLS CUI [2]
C0011946
5. atrial fibrillation or other markedly irregular rhythm.
Description

Atrial Fibrillation | Cardiac Arrhythmia

Data type

boolean

Alias
UMLS CUI [1]
C0004238
UMLS CUI [2]
C0003811
6. inability or refusal to provide informed consent.
Description

informed consent

Data type

boolean

Alias
UMLS CUI [1]
C0021430
7. psychological unsuitability or extreme claustrophobia.
Description

Mental disorders | Claustrophobia

Data type

boolean

Alias
UMLS CUI [1]
C0004936
UMLS CUI [2]
C0008909
8. pregnancy or unknown pregnancy status.
Description

pregnancy

Data type

boolean

Alias
UMLS CUI [1]
C0032961
9. age less than 18 years.
Description

age

Data type

boolean

Alias
UMLS CUI [1]
C0001779
10. clinical instability as deemed by the attending physician; including cardiogenic shock, hypotension (systolic blood pressure < 90 mmhg), refractory hypertension (systolic blood pressure > 180 mmhg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
Description

Instability; Clinical | Shock, Cardiogenic | Hypotension | Refractory hypertension | Ventricular arrhythmia; Sustained; Medication administration: intravenous; Atrial arrhythmia

Data type

boolean

Alias
UMLS CUI [1,1]
C1444783
UMLS CUI [1,2]
C0205210
UMLS CUI [2]
C0036980
UMLS CUI [3]
C0020649
UMLS CUI [4]
C0860493
UMLS CUI [5,1]
C0085612
UMLS CUI [5,2]
C0443318
UMLS CUI [5,3]
C0812149
UMLS CUI [5,4]
C0085611
11. patients with known allergy to iodine or shellfish.
Description

patients with known allergy to iodine or shellfish

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0021968
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C1304606
12. inability to tolerate beta blockers, including those with copd or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
Description

Medical contraindication; Adrenergic beta-1 Receptor Antagonists | Chronic Obstructive Airway Disease; Asthma; Inhaled bronchodilator therapy; inhaled steroids | Complete heart block with broad RS complexes; Second degree atrioventricular block

Data type

boolean

Alias
UMLS CUI [1,1]
C1301624
UMLS CUI [1,2]
C0304516
UMLS CUI [2,1]
C0024117
UMLS CUI [2,2]
C0004096
UMLS CUI [2,3]
C0578554
UMLS CUI [2,4]
C2065041
UMLS CUI [3,1]
C1861987
UMLS CUI [3,2]
C0264906
13. computed tomography imaging, or contrast administration, within the past 48 hours.
Description

ct scan or contrast administration

Data type

boolean

Alias
UMLS CUI [1]
C0040405
UMLS CUI [2,1]
C0009924
UMLS CUI [2,2]
C0332157
14. use of viagra or cialis in the past 24 hours.
Description

viagra or cialis

Data type

boolean

Alias
UMLS CUI [1,1]
C0663448
UMLS CUI [1,2]
C0967376
15. patients with known allergy to gadolinium, x-ray dye, persantine
Description

Hypersensitivity; Gadolinium | Hypersensitivity; Persantine | Contrast media allergy

Data type

boolean

Alias
UMLS CUI [1,1]
C0020517
UMLS CUI [1,2]
C0016911
UMLS CUI [2,1]
C0020517
UMLS CUI [2,2]
C0700020
UMLS CUI [3]
C0570562
16. extreme claustrophobia.
Description

severe claustrophobia

Data type

boolean

Alias
UMLS CUI [1,1]
C0008909
UMLS CUI [1,2]
C0205082
17. patients with metal implants that prevent mri scanning
Description

patients with metal implants that prevent mri scanning

Data type

boolean

Alias
UMLS CUI [1,1]
C0025552
UMLS CUI [1,2]
C0021102
UMLS CUI [2,1]
C1301624
UMLS CUI [2,2]
C0024485
18. patients with a body weight > 400 lbs
Description

body weight

Data type

boolean

Alias
UMLS CUI [1]
C0005910
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Similar models

Eligibility Coronary Disease NCT00538460

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
chest pain or other symptoms suggestive of acute cardiac ischemia
Item
1. patients with chest pain or other symptoms suggestive of acute cardiac ischemia.
boolean
C0008031 (UMLS CUI [1])
C0151744 (UMLS CUI [2,1])
C1457887 (UMLS CUI [2,2])
timi risk score
Item
2. low risk timi risk score (ie. ≤3)
boolean
C3272266 (UMLS CUI [1])
informed consent
Item
3. able to provide informed consent
boolean
C0021430 (UMLS CUI [1])
age
Item
4. age equal to or greater than 18 years.
boolean
C0001779 (UMLS CUI [1])
Item Group
C0680251 (UMLS CUI)
ECG signs of myocardial ischaemia | ST segment elevation myocardial infarction | ST segment depression (finding) | ECG T wave inversion new | physicians evaluation
Item
1. electrocardiographic evidence of ischemia, including acute stemi (st elevation equal to or greater than 1mm in two or more leads), st segment depression and/or t wave inversion (not known to be old), or attending physician clinical decision for immediate invasive evaluation.
boolean
C1141959 (UMLS CUI [1])
C1536220 (UMLS CUI [2])
C0520887 (UMLS CUI [3])
C0743447 (UMLS CUI [4])
C2066348 (UMLS CUI [5])
Cardiac biomarkers; Troponin measurement; Myoglobin measurement; Creatine kinase MB measurement
Item
2. positive cardiac biomarkers (troponin, myoglobin, and/or creatinine phosphokinase mb fraction).
boolean
C2735102 (UMLS CUI [1,1])
C0523952 (UMLS CUI [1,2])
C0373680 (UMLS CUI [1,3])
C0523584 (UMLS CUI [1,4])
Coronary Artery Disease; History of myocardial infarction; History of coronary artery bypass surgery (CABG); coronary angiography: coronary artery findings | Cardiomyopathies; Cardiac ejection fraction
Item
3. presence of pre-existing cad (prior myocardial infarction, prior angiographic evidence of significant cad, prior coronary bypass surgery) or cardiomyopathy (ejection fraction < 45%)
boolean
C1956346 (UMLS CUI [1,1])
C1275835 (UMLS CUI [1,2])
C1842251 (UMLS CUI [1,3])
C2041526 (UMLS CUI [1,4])
C0878544 (UMLS CUI [2,1])
C0232174 (UMLS CUI [2,2])
creatinine, dialysis
Item
4. renal insufficiency (creatinine ≥1.6) or renal failure requiring dialysis.
boolean
C0201976 (UMLS CUI [1])
C0011946 (UMLS CUI [2])
Atrial Fibrillation | Cardiac Arrhythmia
Item
5. atrial fibrillation or other markedly irregular rhythm.
boolean
C0004238 (UMLS CUI [1])
C0003811 (UMLS CUI [2])
informed consent
Item
6. inability or refusal to provide informed consent.
boolean
C0021430 (UMLS CUI [1])
Mental disorders | Claustrophobia
Item
7. psychological unsuitability or extreme claustrophobia.
boolean
C0004936 (UMLS CUI [1])
C0008909 (UMLS CUI [2])
pregnancy
Item
8. pregnancy or unknown pregnancy status.
boolean
C0032961 (UMLS CUI [1])
age
Item
9. age less than 18 years.
boolean
C0001779 (UMLS CUI [1])
Instability; Clinical | Shock, Cardiogenic | Hypotension | Refractory hypertension | Ventricular arrhythmia; Sustained; Medication administration: intravenous; Atrial arrhythmia
Item
10. clinical instability as deemed by the attending physician; including cardiogenic shock, hypotension (systolic blood pressure < 90 mmhg), refractory hypertension (systolic blood pressure > 180 mmhg), sustained ventricular or atrial arrhythmia requiring intravenous medications.
boolean
C1444783 (UMLS CUI [1,1])
C0205210 (UMLS CUI [1,2])
C0036980 (UMLS CUI [2])
C0020649 (UMLS CUI [3])
C0860493 (UMLS CUI [4])
C0085612 (UMLS CUI [5,1])
C0443318 (UMLS CUI [5,2])
C0812149 (UMLS CUI [5,3])
C0085611 (UMLS CUI [5,4])
patients with known allergy to iodine or shellfish
Item
11. patients with known allergy to iodine or shellfish.
boolean
C0020517 (UMLS CUI [1,1])
C0021968 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C1304606 (UMLS CUI [2,2])
Medical contraindication; Adrenergic beta-1 Receptor Antagonists | Chronic Obstructive Airway Disease; Asthma; Inhaled bronchodilator therapy; inhaled steroids | Complete heart block with broad RS complexes; Second degree atrioventricular block
Item
12. inability to tolerate beta blockers, including those with copd or asthma requiring maintenance inhaled bronchodilators or steroids, complete heart block, second-degree atrioventricular block.
boolean
C1301624 (UMLS CUI [1,1])
C0304516 (UMLS CUI [1,2])
C0024117 (UMLS CUI [2,1])
C0004096 (UMLS CUI [2,2])
C0578554 (UMLS CUI [2,3])
C2065041 (UMLS CUI [2,4])
C1861987 (UMLS CUI [3,1])
C0264906 (UMLS CUI [3,2])
ct scan or contrast administration
Item
13. computed tomography imaging, or contrast administration, within the past 48 hours.
boolean
C0040405 (UMLS CUI [1])
C0009924 (UMLS CUI [2,1])
C0332157 (UMLS CUI [2,2])
viagra or cialis
Item
14. use of viagra or cialis in the past 24 hours.
boolean
C0663448 (UMLS CUI [1,1])
C0967376 (UMLS CUI [1,2])
Hypersensitivity; Gadolinium | Hypersensitivity; Persantine | Contrast media allergy
Item
15. patients with known allergy to gadolinium, x-ray dye, persantine
boolean
C0020517 (UMLS CUI [1,1])
C0016911 (UMLS CUI [1,2])
C0020517 (UMLS CUI [2,1])
C0700020 (UMLS CUI [2,2])
C0570562 (UMLS CUI [3])
severe claustrophobia
Item
16. extreme claustrophobia.
boolean
C0008909 (UMLS CUI [1,1])
C0205082 (UMLS CUI [1,2])
patients with metal implants that prevent mri scanning
Item
17. patients with metal implants that prevent mri scanning
boolean
C0025552 (UMLS CUI [1,1])
C0021102 (UMLS CUI [1,2])
C1301624 (UMLS CUI [2,1])
C0024485 (UMLS CUI [2,2])
body weight
Item
18. patients with a body weight > 400 lbs
boolean
C0005910 (UMLS CUI [1])
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