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

NCT01949844 | Completed Results

• 1 other identifier: 28466
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease; CAD

Keywords

MRI; Magnetic Resonance Imaging; myocardial perfusion; myocardial perfusion imaging; Novel MRI Techniques

Outcome Measures

Primary Outcomes (1)

• Diagnostic Performance (Specificity and Sensitivity) for Detection of Myocardial Perfusion Deficits on Magnetic Resonance (MR) Images

  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

Study Arms (1)

Suspected coronary artery disease (CAD)

OTHER

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; Drug: Optimark®; Device: Myocardial perfusion MRI

Interventions

regadenoson DRUG

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.

Also known as: Lexiscan®

Suspected coronary artery disease (CAD)

Optimark® DRUG

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.

Also known as: gadoversetamide, gadolinium, MRI contrast agent, gadolinium contrast

Suspected coronary artery disease (CAD)

Myocardial perfusion MRI DEVICE

Also known as: magnetic resonance imaging, ischemia, cardiac blood flow, perfusion

Suspected coronary artery disease (CAD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• \< 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.

Sponsors & Collaborators

• Daniel S. Berman: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

regadenoson; gadoversetamide; Gadolinium; gadolinium compound P760; Magnetic Resonance Imaging; Perfusion

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals; Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques

Limitations and Caveats

This pilot study did not have a control/placebo arm and did not involve evaluation of the efficacy of a drug but rather the performance of an improved magnetic resonance imaging (MRI) technique with reduced image artifacts.

Results Point of Contact

• Title: Dr. Behzad Sharif, Assistant Professor
• Organization: Cedars-Sinai Medical Center

310-423-7758

Study Officials

• Daniel S Berman, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief, Cardiac Imaging / Nuclear Cardiology

Study Record Dates

• First Submitted: September 11, 2013
• First Posted: September 25, 2013
• Study Start: May 16, 2014
• Primary Completion: January 15, 2017
• Study Completion: October 23, 2017
• Last Updated: August 20, 2018
• Results First Posted: June 25, 2018

Record last verified: 2018-08

Locations

US (1)