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

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.

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Key information

Conditions

Coronary Artery Disease Arterial Occlusive Diseases Arteriosclerosis Atherosclerosis Cardiovascular Diseases Coronary Disease Heart Diseases Myocardial Ischemia Vascular Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

GENERAL INCLUSION CRITERIA:
18 years of age and older
Prior equivocal stress study within the preceding 90 days
Able to provide informed consent

MEDICAL EXCLUSION CRITERIA:

Decompensated heart failure (unable to lie flat during MRI or CT)
Severe kidney disease (MDRD estimated Glomerular Filtration Rate less than 30mL/min/1.73m(2).
Prior cardiac revascularization with coronary stent or bypass surgery
Resting tachycardia (HR greater than l00 bpm)
Pregnant women (when uncertain, subjects will undergo urine or blood testing)
Lactating women (unless they are willing to discard breast milk for 24 hours after receiving gadolinium)
Second (Type II) and third degree atrioventricular heart block
Asthma or chronic pulmonary disease (emphysema) actively treated with bronchodilators or leukotriene antagonists

MRI EXCLUSION CRITERIA:

Cardiac pacemaker or implantable defibrillator
Cerebral aneurysm clip
Neural stimulator (e.g. TENS-Unit)
Any type of ear implant
Ocular foreign body (e.g. metal shavings)
Any implanted device (e.g. insulin pump, drug infusion device)
Metal shrapnel or bullet

Treatment and study plan

Primary outcomes

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.

Time frame: 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 outcomes

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.

Time frame: end of study

compare the cost-effectiveness of MRI with CT for this patient population.

Sponsors and collaborators

Lead sponsor

National Heart, Lung, and Blood Institute (NHLBI)

Nih

Registry information

Important dates

Study start: 2009
Primary completion: 2018
Study completion: 2020
First posted: Jun 26, 2009
Registry last updated: Dec 3, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed