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
This study has been completed.
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00929227
First received: June 25, 2009
Last updated: May 1, 2013
Last verified: March 2013
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Purpose
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.
| Condition |
|---|
|
Myocardial Ischemia Coronary Artery Disease Myocardial Infarction |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | 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 |
Resource links provided by NLM:
Further study details as provided by National Institutes of Health Clinical Center (CC):
| Enrollment: | 109 |
| Study Start Date: | June 2009 |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929227
Locations
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | |
| Bethesda, Maryland, United States, 20892 | |
| Suburban Hospital | |
| Bethesda, Maryland, United States, 20814 | |
Sponsors and Collaborators
Investigators
| Principal Investigator: | Andrew E Arai, M.D. | National Heart, Lung, and Blood Institute (NHLBI) |
More Information
Additional Information:
Publications:
| ClinicalTrials.gov Identifier: | NCT00929227 History of Changes |
| Other Study ID Numbers: | 090164, 09-H-0164 |
| Study First Received: | June 25, 2009 |
| Last Updated: | May 1, 2013 |
| Health Authority: | United States: Federal Government |
Keywords provided by National Institutes of Health Clinical Center (CC):
|
Atherosclerosis Myocardial Ischemia Diagnostic Testing |
Cardiac Commuted Tomography Cardiac Magnetic Resonance Imaging Coronary Artery Disease |
Additional relevant MeSH terms:
|
Coronary Artery Disease Myocardial Ischemia Coronary Disease Infarction Ischemia Myocardial Infarction Heart Diseases Cardiovascular Diseases Arteriosclerosis |
Arterial Occlusive Diseases Vascular Diseases Pathologic Processes Necrosis Vasodilator Agents Cardiovascular Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013