Identification of Adverse Plaque Characteristics by Coronary MR Angiography

Sponsor

Cedars-Sinai Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT01986868

Collaborator

(none)

Enrollment

Location

Arm

69.8

Actual Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Coronary Artery Disease	Other: Coronary MR Angiography (CMRA)	N/A

Detailed Description

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

2 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Identification of Adverse Plaque Characteristics by Coronary Magnetic Resonance Angiography

Actual Study Start Date :

Apr 1, 2012

Actual Primary Completion Date :

Jan 24, 2018

Actual Study Completion Date :

Jan 24, 2018

Arms and Interventions

Arm	Intervention/Treatment
Other: Coronary MR Angiography (CMRA) 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) 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

Arm

Intervention/Treatment

Other: Coronary MR Angiography (CMRA)

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)

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

Outcome Measures

Primary Outcome Measures

Adverse plaque characteristics present on CMRA [one day]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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