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

Coronary Artery Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929227
• Other study ID #: 090164
• Secondary ID: 09-H-0164
• Status: Completed
• Start date: July 1, 2009
• Est. completion date: November 19, 2020

Study information

• Verified date: November 2021
• Source: National Institutes of Health Clinical Center (CC)
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 109
• Est. completion date: November 19, 2020
• Est. primary completion date: January 12, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

• 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

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center, 9000 Rockville Pike	Bethesda	Maryland
United States	Suburban Hospital	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Heart, Lung, and Blood Institute (NHLBI)

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

Hendel RC, Wackers FJ, Berman DS, Ficaro E, DePuey EG, Klein L, Cerqueira M; American Society of Nuclear Cardiology. American Society of Nuclear Cardiology consensus statement: Reporting of radionuclide myocardial perfusion imaging studies. J Nucl Cardiol. 2006 Nov;13(6):e152-6. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	estimate the sensitivity, specificity, and accuracy of MRI and CT, for detecting obstructive CAD in patients with a prior equivocal stress study	end of study
Secondary	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.	compare the cost-effectiveness of MRI with CT for this patient population.	end of study

External Links

•   NIH Clinical Center Detailed Web Page