Comparison of Cardiac Computed Tomography and Vasodilator Stress Magnetic Resonance Imaging Perfusion in Patients With Prior Equivocal Stress Test for Detection of Coronary Artery Disease

Completed

• Conditions: Coronary Artery Disease

• Registration Number: NCT00929227
• Lead Sponsor: National Heart, Lung, and Blood Institute (NHLBI)

Brief Summary

Background:

* Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate further expensive testing.

* In patients with known or suspected coronary artery disease, both computed tomography (CT) and magnetic resonance imaging (MRI) have been shown to provide suitable results for detecting the disease. However, both types of scans have limitations in their usefulness, and it is not known whether one is preferable in either accuracy or cost-effectiveness.

Objectives:

- To determine the accuracy and cost-effectiveness of CT and MRI in subjects with a prior inconclusive heart stress test.

Eligibility:

- Patients 18 years of age and older who have had an inconclusive heart stress test within the past 90 days.

Design:

* A blood test will be obtained prior to both heart tests. This will require less than a teaspoon of blood.

* A CT scan will be performed, accompanied by beta blocker medications (to slow heart rate) or nitroglycerin (to enlarge blood vessels) to improve picture quality, as needed.

* An MRI scan will be performed. Scans will be taken before, during, and after the patient receives vasodilators (to increase blood flow to the coronary arteries and detect blockages in heart blood vessels).

* Heart rate and function will be monitored with an electrocardiogram.

Detailed Description

Noninvasive cardiac stress testing is imperfect. Inconclusive test results generate further expensive testing. We will do both cardiac computed tomography (CT) and stress cardiac magnetic resonance imaging (MRI) in patients who have an inconclusive noninvasive cardiac stress test. We will test whether MRI predicts significant coronary artery disease in a more cost-effective and accurate manner than CT, or vice versa.

Study Timeline

• Study First Submitted: 2009-06-25
• Study First Submitted QC: 2009-06-25
• Study First Posted: 2009-06-26
• Study Start: 2009-07-01
• Primary Completion: 2018-01-12
• Study Completion: 2020-11-19
• Status Verified: 2021-11
• Last Update Submitted: 2021-12-01
• Last Update Posted: 2021-12-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 109

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Stress MRI perfusion, and cardiac CT will have observed sensitivity, specificity, and accuracy of at least 0.80 in predicting CAD in a patient population with prior equivocal stress testing.	end of study	estimate the sensitivity, specificity, and accuracy of MRI and CT, for detecting obstructive CAD in patients with a prior equivocal stress study

Secondary Outcome Measures

Name	Time	Method
The null hypothesis is that there will be no difference between stress MRI perfusion and cardiac CT with respect to the diagnostic costs for patients with an equivocal stress study for CAD.	end of study	compare the cost-effectiveness of MRI with CT for this patient population.

Trial Locations

Locations (2)

Suburban Hospital; 🇺🇸 Bethesda, Maryland, United States

National Institutes of Health Clinical Center, 9000 Rockville Pike; 🇺🇸 Bethesda, Maryland, United States