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

NCT02092428 | Completed Phase 1

• 2 other identifiers: 233115R01EB002623-07
• Study Type: interventional
• Target: 333
• Locations: 1 country
• Sites: 1

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

Conditions

Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

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

  sensitivity and specificity

  one day

Study Arms (2)

Image Quality

EXPERIMENTAL

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

Other: Image Quality

Diagnostic Accuracy

EXPERIMENTAL

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

Other: Diagnostic Accuracy

Interventions

Image Quality 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.

Also known as: MRI with contrast, contrast-enhance MRI, non-contrast MRI, gadolinium-based contrast, adenosine, regadenoson

Image Quality

Diagnostic Accuracy OTHER

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

Also known as: conventional x-ray angiography., contrast-enhanced MRI, non-contrast MRI, gadolinium-based contrast, adenosine, regadenoson

Diagnostic Accuracy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead
• National Institute for Biomedical Imaging and Bioengineering (NIBIB): collaborator

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Image Enhancement; Magnetic Resonance Spectroscopy; Contrast Media; Adenosine; regadenoson

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Photography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Purine Nucleosides; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleosides

Study Officials

• Debiao Li, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biomedical Imaging Research Institute

Study Record Dates

• First Submitted: March 4, 2014
• First Posted: March 20, 2014
• Study Start: April 1, 2011
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: March 23, 2018

Record last verified: 2018-03

Locations

US (1)