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

August 16, 2018 updated by: Daniel S. Berman

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

44

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Clinically indicated nuclear myocardial perfusion (PET/SPECT) study with mild to moderate ischemia or prior myocardial infarction AND a visual scan interpretation of definitely abnormal AND no intervening revascularization since the prior study; or,
  • Clinically stable individuals with suspected or known coronary artery disease on the basis of coronary angiography.

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 contrast protocol requirements (GFR <45 ml/min based on serum creatinine, age, gender, and ethnicity).
  • 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Suspected coronary artery disease (CAD)

This pilot study has a single arm/group of subjects with suspected CAD based on the following inclusion criteria:

  1. Prior nuclear myocardial perfusion scan (PET/SPECT) with a visual interpretation of definitely abnormal, or prior myocardial infarction; or,
  2. Clinically stable individuals with suspected coronary artery disease on the basis of coronary angiography.

The study protocol involved only a myocardial perfusion MRI procedure for detection of ischemia (perfusion deficits) using an improved protocol with the administration of a vasodilator drug (Regadenoson/Lexiscan®) and gadolinium-based MRI contrast agent (Optimark®; dose: 0.2 mmol/kg). Lexiscan® was used off-label as a vasodilator drug during the MRI scan (0.4 mg/5mL) supplied by the manufacturer, Astellas Pharma U.S.
Drug: regadenoson
Lexiscan® is being used off-label. The FDA Issued IND # is 119898. For the cardiac MRI, Lexiscan® will be used at the same dosage and administration as prescribed in the package insert - 5 mL (0.4 mg regadenoson) as packaged and supplied by the manufacturer, Astellas Pharma U.S., in single-use pre-filled syringes administered by rapid intravenous injection, followed immediately by saline flush.
Other Names:
  • Lexiscan®
Drug: Optimark®
For the cardiac MR, the contrast agent, Optimark® is administered as a bolus peripheral intravenous injection at a dose of 0.2 mL/kg (0.1 mmol/kg) and at a rate of 1 to 2 mL/sec delivered by manual injection.
Other Names:
  • gadoversetamide
  • gadolinium
  • MRI contrast agent
  • gadolinium contrast
Device: Myocardial perfusion MRI
Other Names:
  • magnetic resonance imaging
  • ischemia
  • cardiac blood flow
  • perfusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images
Time Frame: Baseline only
In this study, the approach is to use nuclear myocardial perfusion (prior PET/SPECT scans for the enrolled patients) as the comparative standard for detection of myocardial ischemia (presence of perfusion deficits). Using this approach, the acquired MR images will be analyzed to determine the diagnostic performance (specificity and sensitivity) of the improved MRI technique for detection of myocardial perfusion deficits.
Baseline only

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniel S. Berman

Collaborators

Astellas Pharma US, Inc.

Investigators

  • Principal Investigator: Daniel S Berman, MD, Cedars-Sinai Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 16, 2014

Primary Completion (Actual)

January 15, 2017

Study Completion (Actual)

October 23, 2017

Study Registration Dates

First Submitted

September 11, 2013

First Submitted That Met QC Criteria

September 20, 2013

First Posted (Estimate)

September 25, 2013

Study Record Updates

Last Update Posted (Actual)

August 20, 2018

Last Update Submitted That Met QC Criteria

August 16, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 28466

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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