Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Identification of Adverse Plaque Characteristics by Coronary MR Angiography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01986868
Recruitment Status : Unknown
Verified August 2017 by Daniel S. Berman, Cedars-Sinai Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : November 19, 2013
Last Update Posted : August 16, 2017
Sponsor:
Information provided by (Responsible Party):
Daniel S. Berman, Cedars-Sinai Medical Center

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) Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 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
Study Start Date : April 2012
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. Adverse plaque characteristics present on CMRA [ Time Frame: one day ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01986868


Locations
Layout table for location information
United States, California
Cedars-Sinai Medical Center
Los Angeles, California, United States, 90048
Sponsors and Collaborators
Cedars-Sinai Medical Center
Investigators
Layout table for investigator information
Principal Investigator: Daniel S Berman, MD Cedars-Sinai Medical Center
Layout table for additonal information
Responsible Party: Daniel S. Berman, Principal Investigator, Cedars-Sinai Medical Center
ClinicalTrials.gov Identifier: NCT01986868    
Other Study ID Numbers: 27850
First Posted: November 19, 2013    Key Record Dates
Last Update Posted: August 16, 2017
Last Verified: August 2017
Keywords provided by Daniel S. Berman, Cedars-Sinai Medical Center:
Coronary Magnetic Resonance Angiography
CMRA
MRI with contrast
MultiHance
Optimark
Gadolinium-based contrast
MRA
MR angiography
Additional relevant MeSH terms:
Layout table for MeSH terms
Coronary Artery Disease
Coronary Disease
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases