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: March 14, 2014
Last verified: February 2014
  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):

Primary Outcome Measures:
  • Stress MRI perfusion is more cost-effective than cardiac CT in patients with an equivocal stress study in predicting CAD, or vise versa.

Secondary Outcome Measures:
  • Stress MRI perfusion and/or cardiac CTA will maintain reasonable sensitivity, specificity, and accuracy in predicting CAD in a patient population with prior equivocal stress testing.

Enrollment: 109
Study Start Date: June 2009
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.

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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:
Brindis RG, Douglas PS, Hendel RC, Peterson ED, Wolk MJ, Allen JM, Patel MR, Raskin IE, Hendel RC, Bateman TM, Cerqueira MD, Gibbons RJ, Gillam LD, Gillespie JA, Hendel RC, Iskandrian AE, Jerome SD, Krumholz HM, Messer JV, Spertus JA, Stowers SA; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American Society of Nuclear Cardiology; American Heart Association. ACCF/ASNC appropriateness criteria for single-photon emission computed tomography myocardial perfusion imaging (SPECT MPI): a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group and the American Society of Nuclear Cardiology endorsed by the American Heart Association. J Am Coll Cardiol. 2005 Oct 18;46(8):1587-605. Review. Erratum in: J Am Coll Cardiol. 2005 Dec 6;46(11):2148-50.
Hendel RC, Patel MR, Kramer CM, Poon M, Hendel RC, Carr JC, Gerstad NA, Gillam LD, Hodgson JM, Kim RJ, Kramer CM, Lesser JR, Martin ET, Messer JV, Redberg RF, Rubin GD, Rumsfeld JS, Taylor AJ, Weigold WG, Woodard PK, Brindis RG, Hendel RC, Douglas PS, Peterson ED, Wolk MJ, Allen JM, Patel MR; American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group; American College of Radiology; Society of Cardiovascular Computed Tomography; Society for Cardiovascular Magnetic Resonance; American Society of Nuclear Cardiology; North American Society for Cardiac Imaging; Society for Cardiovascular Angiography and Interventions; Society of Interventional Radiology. ACCF/ACR/SCCT/SCMR/ASNC/NASCI/SCAI/SIR 2006 appropriateness criteria for cardiac computed tomography and cardiac magnetic resonance imaging: a report of the American College of Cardiology Foundation Quality Strategic Directions Committee Appropriateness Criteria Working Group, American College of Radiology, Society of Cardiovascular Computed Tomography, Society for Cardiovascular Magnetic Resonance, American Society of Nuclear Cardiology, North American Society for Cardiac Imaging, Society for Cardiovascular Angiography and Interventions, and Society of Interventional Radiology. J Am Coll Cardiol. 2006 Oct 3;48(7):1475-97. Review. No abstract available.

ClinicalTrials.gov Identifier: NCT00929227     History of Changes
Other Study ID Numbers: 090164, 09-H-0164
Study First Received: June 25, 2009
Last Updated: March 14, 2014
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 August 26, 2014