search
Back to results

Identification of Adverse Plaque Characteristics by Coronary MR Angiography

Primary Purpose

Coronary Artery Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Coronary MR Angiography (CMRA)
Sponsored by
Cedars-Sinai Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Coronary Artery Disease focused on measuring Coronary Magnetic Resonance Angiography, CMRA, MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR angiography

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • Cedars-Sinai Medical Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Coronary MR Angiography (CMRA)

Arm Description

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.

Outcomes

Primary Outcome Measures

Adverse plaque characteristics present on CMRA

Secondary Outcome Measures

Full Information

First Posted
November 12, 2013
Last Updated
January 25, 2021
Sponsor
Cedars-Sinai Medical Center
search

1. Study Identification

Unique Protocol Identification Number
NCT01986868
Brief Title
Identification of Adverse Plaque Characteristics by Coronary MR Angiography
Official Title
Identification of Adverse Plaque Characteristics by Coronary Magnetic Resonance Angiography
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
April 2012 (Actual)
Primary Completion Date
January 24, 2018 (Actual)
Study Completion Date
January 24, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cedars-Sinai Medical Center

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

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 Angiography, CMRA, MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR angiography

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Coronary MR Angiography (CMRA)
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Coronary MR Angiography (CMRA)
Other Intervention Name(s)
MRI with contrast, MultiHance, Optimark, Gadolinium-based contrast, MRA, MR Imaging, MR angiography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Adverse plaque characteristics present on CMRA
Time Frame
one day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel S Berman, MD
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

Learn more about this trial

Identification of Adverse Plaque Characteristics by Coronary MR Angiography

We'll reach out to this number within 24 hrs