Artifact-Free High-Resolution Myocardial Perfusion MRI in Subjects With Abnormal Nuclear Myocardial Perfusion Studies

Last updated: August 16, 2018
Sponsor: Daniel S. Berman
Overall Status: Completed

Phase

N/A

Condition

Atherosclerosis

Coronary Artery Disease

Hypercholesterolemia

Treatment

N/A

Clinical Study ID

NCT01949844
28466
  • Ages > 18
  • All Genders

Study Summary

This is a pilot study in a patient population with suspected coronary artery disease (CAD) as defined by the presence of a prior abnormal nuclear (PET/SPECT) myocardial perfusion scan. In this study design, PET/SPECT will serve as the comparative standard for presence of myocardial ischemia. We intend to determine the accuracy of an improved magnetic resonance imaging (MRI) technique for detection of myocardial ischemia in subjects with suspected CAD.

This is not a study to specifically evaluate the efficacy or safety of the drugs but rather the diagnostic performance of the improved cardiac MRI procedure.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Clinically indicated nuclear myocardial perfusion (PET/SPECT) study with mild tomoderate ischemia or prior myocardial infarction AND a visual scan interpretation ofdefinitely abnormal AND no intervening revascularization since the prior study; or,

  • Clinically stable individuals with suspected or known coronary artery disease on thebasis of coronary angiography.

Exclusion

Exclusion Criteria:

  • < 18 years of age

  • Hypotension (systolic blood pressure <100 mm Hg)

  • Significant non-coronary cardiac disease (e.g. severe valvular abnormality,significant cardiomyopathy, etc.)

  • Persons unable to successfully pass MRI health and safety screening

  • Persons whose renal function test does not meet CSMC standard of care MRI contrastprotocol requirements (GFR <45 ml/min based on serum creatinine, age, gender, andethnicity).

  • Subjects with contraindications to or intolerance of regadenoson.

  • Persons with an allergy to gadolinium-based contrast.

  • Persons with a history of kidney or liver disease.

Study Design

Total Participants: 44
Study Start date:
May 16, 2014
Estimated Completion Date:
October 23, 2017

Study Description

A total of two imaging protocols will be used as "protocol options" in this study (only one of the protocols will be used for each enrolled subject): (1) "Two-day protocol," which involves MRI of subjects who have had a recent abnormal PET/SPECT study and includes an optional second-day visit; (2) "One-day protocol," which involves the subjects undergoing stress myocardial perfusion SPECT and MRI in the same day.

Two blinded readers will interpret MR and SPECT/PET studies by consensus to assess the presence of perfusion deficits at stress and rest.

Connect with a study center

  • Cedars-Sinai Medical Center

    Los Angeles, California 90048
    United States

    Site Not Available

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