Ignite Creation Date:
2024-05-05 @ 6:48 PM
Last Modification Date:
2024-10-26 @ 9:36 AM
Study NCT ID:
NCT00541203
Status:
COMPLETED
Last Update Posted:
2012-03-21
First Post:
2007-10-09
Brief Title:
Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests
Sponsor:
William Beaumont Hospitals
Organization:
William Beaumont Hospitals
Study Overview
Official Title:
Cardiac Computed Tomography In the Management of Patients With indeterminAte or inConclusive Stress Tests
Status:
COMPLETED
Status Verified Date:
2012-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CT-MPACT
Brief Summary:
Coronary CT angiography CCTA offers great promise as a risk stratification tool in patients with suspected CAD It has been demonstrated in a multitude of accuracy studies to have a negative predictive value averaging over 95 This leads to the hypothesis that a negative CCTA may preclude the need for invasive testing The purpose of this randomized controlled study is to prospectively evaluate the role of CCTA on the management of patients with inconclusive or indeterminate stress test resultsCCTA is able to provide not only information on presence and extent of coronary artery calcification but detailed coronary anatomy as well
SPECIFIC AIM 1 To evaluate the diagnostic and prognostic performance of CCTA in patients with equivocal intermediate stress test results as compared to conventional invasive coronary angiography
SPECIFIC AIM 2 To evaluate the utility of CCTA in prediction of major adverse cardiac events MACE compared to invasive coronary angiography at 30 days 1 year 3 years and 5 years
SPECIFIC AIM 1 To evaluate the diagnostic and prognostic performance of CCTA in patients with equivocal intermediate stress test results as compared to conventional invasive coronary angiography
SPECIFIC AIM 2 To evaluate the utility of CCTA in prediction of major adverse cardiac events MACE compared to invasive coronary angiography at 30 days 1 year 3 years and 5 years
Detailed Description:
Outpatients scheduled to undergo cardiac catheterization and coronary angiography for the specific indication of inconclusive or indeterminate stress tests will be considered for this study Patients will be initially screened by their cardiologist for the presence of inclusionexclusion criteria as well as pre-test and post-test likelihood of CAD16 17 All patients must have undergone a stress exercise or pharmacologic test within the past 3 months
After consent patients will be randomized 11 to undergo CCTA or cardiac catheterization The decision whether or not to proceed with subsequent invasive cardiac catheterization CCTA arm or revascularization catheterization arm will be made by the patients primary and interventional cardiologists respectively
Inclusion
1 Chest pain or other symptoms suggestive of coronary artery disease
2 Pharmacologicexercise stress test with SPECT nuclear myocardial-heart perfusion imaging within the past 3 months
3 Discordant or conflicting findings clinical and stress results as outlined above
4 Scheduled to undergo cardiac catheterization
5 Able to provide informed consent
6 Age equal to or greater than 18 years
Exclusion
1 Presence of pre-existing heart disease prior heart attack prior angiographic evidence of significant heart disease prior heart surgery or cardiomyopathy ejection fraction less than or equal to 45
2 History of high blood pressure with severe left ventricular hypertrophy thicken heart muscle history of cor pulmonale right heart chamber failure due to elevated blood pressures in the arteries delivering blood to the lungs
3 Kidney insufficiency creatinine greater than or equal to 16 or kidney failure requiring dialysis
4 Inability or refusal to provide informed consent
5 Psychological unsuitability or extreme claustrophobia fear of closed in spaces
6 Pregnancy or unknown pregnancy status
7 Age less than 18 years
8 Patients with known allergy to iodinated contrast unable to tolerate pre-medication
9 Inability to tolerate beta-blockers medication to slow the heart rate including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids complete heart block second-degree atrioventricular block
10 Computed tomography imaging or contrast administration within the past 48 hours
After consent patients will be randomized 11 to undergo CCTA or cardiac catheterization The decision whether or not to proceed with subsequent invasive cardiac catheterization CCTA arm or revascularization catheterization arm will be made by the patients primary and interventional cardiologists respectively
Inclusion
1 Chest pain or other symptoms suggestive of coronary artery disease
2 Pharmacologicexercise stress test with SPECT nuclear myocardial-heart perfusion imaging within the past 3 months
3 Discordant or conflicting findings clinical and stress results as outlined above
4 Scheduled to undergo cardiac catheterization
5 Able to provide informed consent
6 Age equal to or greater than 18 years
Exclusion
1 Presence of pre-existing heart disease prior heart attack prior angiographic evidence of significant heart disease prior heart surgery or cardiomyopathy ejection fraction less than or equal to 45
2 History of high blood pressure with severe left ventricular hypertrophy thicken heart muscle history of cor pulmonale right heart chamber failure due to elevated blood pressures in the arteries delivering blood to the lungs
3 Kidney insufficiency creatinine greater than or equal to 16 or kidney failure requiring dialysis
4 Inability or refusal to provide informed consent
5 Psychological unsuitability or extreme claustrophobia fear of closed in spaces
6 Pregnancy or unknown pregnancy status
7 Age less than 18 years
8 Patients with known allergy to iodinated contrast unable to tolerate pre-medication
9 Inability to tolerate beta-blockers medication to slow the heart rate including those with COPD or asthma requiring maintenance inhaled bronchodilators or steroids complete heart block second-degree atrioventricular block
10 Computed tomography imaging or contrast administration within the past 48 hours
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None