Recruiting

Coronary Atherosclerosis

Sponsor:

Cedars-Sinai Medical Center

Code:

NCT03504956

Conditions

Coronary Atherosclerosis

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Cardiac MRI

Contrast

Beta blocker

Study Details

Brief summary:

This study proposes to develop an MRI technique named Coronary Atherosclerosis T1-weighed Characterization (CATCH) that will improve the quality and reliability of coronary atherosclerosis evaluation, as well as simplify the scanning process and significantly shorten imaging time compared with conventional imaging methods.

Conditions

Coronary Atherosclerosis

Study ID

NCT03504956

Start date

Jul 30, 2018

Status verified date

Jul, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Jun 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Inclusion:

  • Healthy Volunteers: male or female ≥ 18 years of age with a BMI<30, with no history of cardiovascular disease
  • Patients: Medically stable, male or female ≥ 18 years of age who is have not suspected of having or has been diagnosed with coronary artery disease and undergone stenting or bypass surgery

Exclusion:

  • Contraindications to MR imaging including mechanically, magnetically, or electrically activated implants, ferromagnetic implants and ferromagnetic foreign bodies, pregnancy.
  • Inability to tolerate MR imaging secondary to an inability to hold breath for a short time or have claustrophobia.
  • Non-compliant with visit instructions, including following procedure instructions
  • Severe allergy to animal dander or animal-instigated asthma
  • Specific to gadolinium-based contrast agents: Renal function test does not meet CSMC standard of care MRI contrast protocol requirements (GFR <45ml/min) or previous allergic reaction to gadolinium-based contrast agents.\*
  • Volunteers who have had four or more prior previous gadolinium contrast scan

Study Design

Enrollment

150 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Other

Interventions and Outcome Measures

Arms

other: Healthy Volunteers

Approximately 110 healthy male/female adult "normals" or "controls" will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.

other: Coronary Artery Disease (CAD) Patients

40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease (CAD) will receive non-contrast or contrast-enhanced Cardiac MRI. Imaging may include administration of contrast and a beta blocker, based upon the focus of the study at the time of the scan, as well as the safety profile of the participant.

Interventions

Cardiac MRI

MRI with/without administration of a contrast agent and beta-blocker based upon the stage of method development, if no contraindications are present.

Contrast

The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).

Beta blocker

Based upon the focus of the study at the time of the scan, a beta- blocker (metoprolol), in pill form based upon blood pressure and heart rate, may be administered to some subjects to improve the heart's ability to relax and slow the heart rate. The slower heart rate may improve image quality and lessen motion artifact.

Primary outcome measure

  • Plaque to Myocardial Ratio (PMR). [ Time Frame: Day 1 ]

Central Contacts and Locations

Central contacts

Rosalia (Sally) A De Leon

310 423-7758Rosalia.DeLeon@cshs.org

Debiao Li, PhD

310 423-7743debiao.li@cshs.org

Locations

Cedars-Sinai Medical Center

Recruiting

Los Angeles, California, United States, 90048

Contacts

Rhona Littman

310-423-4387Rhona.Littman@cshs.org

Debiao Li, PhD

310 423-7743Debiao.Li@cshs.org

More Information

Sponsor

Cedars-Sinai Medical Center

Last update posted

Aug 21, 2026

Last verified

Jul, 2026

Keywords

  • MRI technique
  • High Resolution MRI Technique

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Cedars-Sinai Medical Center on 2026-08-21.