Identification of Adverse Plaque Characteristics by Coronary MR Angiography

NCT01986868 | Completed

• 1 other identifier: 27850
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

Brief Summary

This is a pilot study to determine whether coronary magnetic resonance angiography(CMRA)can identify adverse plaque characteristics (buildup of fat, cholesterol, calcium, and other substances found in the blood) seen on coronary computed tomography angiography(CCTA) and evaluate whether there is a relationship between the adverse plaque characteristics and the presence of coronary artery wall inflammation.

Conditions

Coronary Artery Disease

Keywords

Coronary Magnetic Resonance Angiography; CMRA; MRI with contrast; MultiHance; Optimark; Gadolinium-based contrast; MRA; MR angiography

Outcome Measures

Primary Outcomes (1)

• Adverse plaque characteristics present on CMRA

  one day

Study Arms (1)

Coronary MR Angiography (CMRA)

OTHER

Coronary MR Angiography(CMRA). A gadolinium-based contrast (Optimark or MultiHance) will be administered as well as a beta blocker which will be assigned based upon heart rate.

Other: Coronary MR Angiography (CMRA)

Interventions

Coronary MR Angiography (CMRA) OTHER

Stable patients who have undergone a clinically indicated CCTA study for suspected Coronary Artery Disease will undergo a research CMRA with contrast (Multihance or Optimark)total dose of up to 0.2 mmol/kg IV. Possible administration of oral beta-blocker (metoprolol)intravenous doses of 5mg IV metoprolol may be given every 2 minutes up to a maximal dose of 15 mg IV.

Also known as: MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR Imaging, MR angiography

Coronary MR Angiography (CMRA)

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years
• Ability to comprehend and sign informed consent
• Presence of a non-calcified or mixed plaque without high-grade stenosis in the left main or a proximal coronary artery segment AND at least one APC present in this plaque by CCTA (defined as LAP with \<30 Hounsfield units or PR with ≥10% increase in the maximal vessel diameter within the plaque as compared to a proximal reference segment as previously described10).

You may not qualify if:

• High-grade stenosis (≥50% stenosis of the left main artery or ≥70% stenosis of another proximal coronary segment);
• Coronary artery stent in the segment with the reference plaque
• Possible pregnancy
• Glomerular filtration rate \<45 ml/min
• More than 90 days between CCTA and CMRA study
• Any significant arrhythmia (e.g. atrial fibrillation, frequent ectopy)
• Significant asthma
• History of 2nd or 3rd degree heart block
• Allergy or known intolerance to beta-blockers
• Use of phosphodiesterase inhibitor (e.g. Viagra) within the last 48 hours
• Rapid heart rate (heart rate ≥90 beats/minute)
• Severe aortic stenosis (Aortic valve area \<1.0 cm2 or mean gradient \>30 mmHg)
• Systolic blood pressure \<100 mmHg
• Other contraindication to MRI, including metallic implants (valve replacement, pacemaker, implantable cardiac defibrillator, metallic spine material), intracranial clips, metallic fragments in eyes, and claustrophobia

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Magnetic Resonance Spectroscopy; Contrast Media; gadobenic acid; gadoversetamide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Officials

• Daniel S Berman, MD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 12, 2013
• First Posted: November 19, 2013
• Study Start: April 1, 2012
• Primary Completion: January 24, 2018
• Study Completion: January 24, 2018
• Last Updated: January 27, 2021

Record last verified: 2021-01

Locations

US (1)