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

NCT ID: NCT02092428

Last Updated: 2018-03-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 333 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-04-30
• Study Completion Date: 2017-03-01

Brief 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.

Detailed Description

This is a study to compare image quality between contrast and non-contrast cardiac MR and to evaluate the diagnostic accuracy of a cardiac MRI procedure in a patient population that includes both healthy volunteers and a study group of patients with known CAD who are scheduled for clinical coronary angiography within one month of signing informed consent. Both groups are eligible for a combination of imaging tests. Subjects may receive either a non-contrast MRI or a contrast-enhanced MRI depending upon their kidney function and study focus. Also based upon the focus of the study at the time of the scan and to improve image quality, a beta-blocker to lessen motion artifact in patients with higher heart rates may be administered or patients may be asked to undergo a stress test for comparison.This is a one-day research procedure. Studies are acquired from the approved Institutional Review Board #25881 Cedars-Sinai Biomedical Imaging Research Registry.

Conditions

Coronary Artery Disease

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Image Quality

Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to compare image quality between contrast and non-contrast scans.

Group Type: EXPERIMENTAL

Image Quality

Intervention Type: OTHER

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.

Diagnostic Accuracy

Healthy volunteers and patients will undergo non-contrast MRI or contrast-enhanced MRI to assess the diagnostic accuracy of coronary MRI in detecting CAD as compared to conventional x-ray angiography

Group Type: EXPERIMENTAL

Diagnostic Accuracy

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: OTHER

Diagnostic Accuracy

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

Intervention Type: OTHER

Other Intervention Names

MRI with contrast; contrast-enhance MRI; non-contrast MRI; gadolinium-based contrast; adenosine; regadenoson; conventional x-ray angiography.; contrast-enhanced MRI; non-contrast MRI; gadolinium-based contrast; adenosine; regadenoson

Eligibility Criteria

Inclusion Criteria

• All subjects must be enrolled in the IRB approved Cedars-Sinai Biomedical Imaging Research Registry where data is collected for this analysis study.
• Male or female ≥ 18years of age
• Healthy Group -No known CAD
• CAD Group-Scheduled for clinical invasive coronary artery x-ray angiography within one month of study participation

Exclusion:

• MR imaging is contraindicated in persons with mechanically, magnetically, or electrically activated implants, such as cardiac pacemakers, neurostimulators, and infusion pumps.
• Persons with ferromagnetic implants and ferromagnetic foreign bodies, such as intracranial, aneurysm clips, shrapnel and intraocular metal chips as these could become dislodged.
• Patients who are pregnant, nursing are implanted with intrauterine devices (IUD's)
• Persons who are in atrial fibrillation at the time of the MR scan as this could result in poor image quality due to interference with electrocardiographic gating necessary for image acquisition.
• Persons unable to tolerate MRI imaging secondary to an inability to lie supine or severe claustrophobia.
• Patient with renal failure (GFR< 45)
• Allergy to animal dander or animal-instigated asthma
• Specific to Ablavar: Baseline ECG measurements and concomitant medications will be checked on subjects who are chosen to participate in the Ablavar study, based upon study needs. If the ECG measurements and/or medications indicate that the subject is at high risk for arrhythmia, the subject will be excluded from the Ablavar study, but can participate in the OptiMark/MultiHance contrast study or non-contrast study.
• Specific to beta-blocker administration: no contraindication to beta blockers. If the subject is found to have a contraindication to beta-blockers or declines the administration of beta-blockers the subject will be excluded from the beta-blocker portion but can still participate in a non-contrast or contrast-enhanced scan without beta-blocker administration.
• Specific to Regadenoson: no contraindication to regadenoson administration. If the subject is found to have a contraindication to regadenoson the subject will be excluded from the regadenoson portion but can still participate in a non-contrast or contrast-enhanced scan without regadenoson stress testing.
• Specific to Adenosine: no contraindication to adenosine administration.If the subject is found to have a contraindication to adenosine the subject will be excluded from the adenosine portion but can still participate in a non-contrast or contrast-enhanced scan without adenosine stress testing.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

Cedars-Sinai Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Debiao Li, PhD

Director, Biomedical Imaging Research Institute

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Debiao Li, PhD

Role: PRINCIPAL_INVESTIGATOR

Cedars-Sinai Medical Center

Locations

Cedars-Sinai Medical Center

Los Angeles, California, United States

Countries

United States

Other Identifiers

5R01EB002623-07

Identifier Type: NIH

Identifier Source: secondary_id

View Link

23311

Identifier Type: -

Identifier Source: org_study_id