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

Primary Purpose

Coronary Artery Disease

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

Image Quality

Diagnostic Accuracy

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Magnetic Resonance Imaging, CAD, Coronary Magnetic Resonance Angiography, MRA, 3 Tesla MRI

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion:

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.

Sites / Locations

Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Image Quality

Diagnostic Accuracy

Arm Description

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

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

Outcomes

Primary Outcome Measures

Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)

sensitivity and specificity

Secondary Outcome Measures

Full Information

NCT ID

NCT02092428

First Posted

March 4, 2014

Last Updated

March 21, 2018

Sponsor

Cedars-Sinai Medical Center

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

1. Study Identification

Unique Protocol Identification Number

NCT02092428

Brief Title

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

Official Title

Contrast- Enhanced Whole-Heart Coronary Magnetic Resonance Angiography (MRA) at 3.0T

Study Type

Interventional

2. Study Status

Record Verification Date

March 2018

Overall Recruitment Status

Completed

Study Start Date

April 2011 (Actual)

Primary Completion Date

March 1, 2017 (Actual)

Study Completion Date

March 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Cedars-Sinai Medical Center

Collaborators

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

4. Oversight

Data Monitoring Committee

5. Study Description

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: compare coronary artery imaging with and without contrast media on both healthy subjects and patients; 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Coronary Artery Disease

Keywords

Coronary Magnetic Resonance Imaging, CAD, Coronary Magnetic Resonance Angiography, MRA, 3 Tesla MRI

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Phase 1

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

333 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Image Quality

Arm Type

Experimental

Arm Description

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

Arm Title

Diagnostic Accuracy

Arm Type

Experimental

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Image Quality

Other Intervention Name(s)

MRI with contrast, contrast-enhance MRI, non-contrast MRI, gadolinium-based contrast, adenosine, regadenoson

Intervention Description

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

Intervention Name(s)

Diagnostic Accuracy

Other Intervention Name(s)

conventional x-ray angiography., contrast-enhanced MRI, non-contrast MRI, gadolinium-based contrast, adenosine, regadenoson

Intervention Description

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

Primary Outcome Measure Information:

Title

Diagnostic performance of 3.0-T contrast-enhanced whole-heart coronary MRA in patients with suspected coronary artery disease (CAD)

Description

sensitivity and specificity

Time Frame

one day

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Debiao Li, PhD

Organizational Affiliation

Cedars-Sinai Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Cedars-Sinai Medical Center

City

Los Angeles

State/Province

California

ZIP/Postal Code

90048

Country

United States

12. IPD Sharing Statement

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

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