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

NCT00929227 | Completed

• 2 other identifiers: 09016409-H-0164
• Study Type: observational
• Target: 109
• Locations: 1 country
• Sites: 2

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.

Conditions

Coronary Artery Disease

Keywords

Inconclusive Noninvasive Cardiac Stress Test; Cardiac Computed Tomography; Coronary Artery Disease; Atherosclerosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (1)

1

Stress MRI perfusion, and cardiac CT will have observed sensitivity, specificity, and accuracyof at least 0.80 in predicting CAD in a patient population with prior equivocal stress testing.

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This trial will involve the NIH Clinical Center and Suburban Hospital. Subjects with an equivocal stress study determined by a referring physician will be recruited from the surrounding community.

You may qualify if:

• years of age and older
• Prior equivocal stress study within the preceding 90 days
• Able to provide informed consent

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• National Heart, Lung, and Blood Institute (NHLBI): lead

Study Sites (2)

Suburban Hospital

Bethesda, Maryland, 20814, United States

Location

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

• 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. doi: 10.1016/j.nuclcard.2006.08.013. No abstract available.

  PMID: 17174791 BACKGROUND

• 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. doi: 10.1016/j.jacc.2005.08.029.

  PMID: 16226194 BACKGROUND

• 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. doi: 10.1016/j.jacc.2006.07.003. No abstract available.

  PMID: 17010819 BACKGROUND

Related Links

• NIH Clinical Center Detailed Web Page

MeSH Terms

Conditions

Coronary Artery Disease; Atherosclerosis

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Arlene Sirajuddin, M.D.

  National Heart, Lung, and Blood Institute (NHLBI)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NIH
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2009
• First Posted: June 26, 2009
• Study Start: July 1, 2009
• Primary Completion: January 12, 2018
• Study Completion: November 19, 2020
• Last Updated: December 3, 2021

Record last verified: 2021-11

Locations

US (2)