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Contrast- Enhanced Whole-Heart Coronary MRA at 3.0T (Tesla)

NCT02092428 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 333

Last updated 2018-03-23

No results posted yet for this study

Summary

Investigators at the Biomedical Imaging Research Institute (BIRI) at Cedars-Sinai Medical Center have developed a Magnetic Resonance Imaging (MRI) method for imaging coronary arteries using slow-infusion, contrast-enhanced data acquisition. This method allows faster data acquisition and better spatial resolution.

Specific aims of this study are to:

1. compare coronary artery imaging with and without contrast media on both healthy subjects and patients;
2. assess the accuracy of coronary MRI in detecting coronary artery disease as compared to conventional x-ray angiography

Researchers hypothesize that contrast-enhanced MRI will improve the delineation of coronary arteries over non-contrast-enhanced MRI and that optimized, contrast-enhanced coronary MRI technique will accurately detect coronary artery disease (CAD) as compared to conventional x-ray angiography.

Conditions

Interventions

OTHER

Image Quality

The following procedures may be conducted as part of this study: * Coronary MRI scan with no contrast * Coronary MRI scan enhanced with a gadolinium-based contrast agent (Optimark, MultiHance, Ablavar) administered intravenously at a total dose of up to 0.2 mmol/kg * MRI scan with an oral beta blocker (metoprolol) * Cardiac Stress Test MRI scan with a pharmacologic stress drug; either adenosine (dosage depends on the subject's weight and is set at 140mcg/kg/min) or regadenoson (0.4mg/5ml bolus) Determination of study drugs will be made depending upon study focus, subjects' health conditions, blood pressure, heart rate and concomitant medications. Both groups are eligible for all combinations of interventions.

OTHER

Diagnostic Accuracy

Both groups are eligible for all combinations of interventions. This arm will also include collection of conventional x-ray angiography.

Sponsors & Collaborators

  • National Institute for Biomedical Imaging and Bioengineering (NIBIB)

    collaborator NIH

  • Cedars-Sinai Medical Center

    lead OTHER

Principal Investigators

  • Debiao Li, PhD · Cedars-Sinai Medical Center

Study Design

Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-04-30
Primary Completion
2017-03-01
Completion
2017-03-01

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02092428 on ClinicalTrials.gov