Skip to main content
OpenTrials
Completed

NCT Number: NCT01986868

Identification of Adverse Plaque Characteristics by Coronary MR Angiography

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

About this study

This pilot study will examine 20 stable patients who have undergone a clinically-indicated coronary computed tomography angiography (CCTA) for suspected Coronary Artery Disease. They will be invited to undergo a research coronary Magnetic Resonance Imaging scan with contrast(CMRA). Based upon the subject's heart rate, a beta blocker may be administered as its use has been shown to be effective in producing better images as it widens the arteries.

Researchers will use newly developed non-invasive coronary MRA techniques to compare information shown on the research CMRA with the clinical CCTA. While CCTA has been demonstrated to be able to provide data on adverse plaque characteristics (APC's), the ability of CMRA to evaluate these features is not established.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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).

Exclusion criteria

  • 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

Treatment and study plan

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.

Other names: MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR Imaging, MR angiography

Primary outcomes

  1. Adverse plaque characteristics present on CMRA

    Time frame: one day

Sponsors and collaborators

Lead sponsor

Cedars-Sinai Medical Center

Other

Registry information

Official study title

Identification of Adverse Plaque Characteristics by Coronary Magnetic Resonance Angiography

Important dates

Study start
2012
Primary completion
2018
Study completion
2018
First posted
Nov 19, 2013
Registry last updated
Jan 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.