Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

NCT03504956 | Recruiting FDA Device

• 1 other identifier: 45312
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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

Keywords

MRI technique; High Resolution MRI Technique

Outcome Measures

Primary Outcomes (1)

• Plaque to Myocardial Ratio (PMR).

  PMR is defined as the ratio between the maximal signal intensity from a vessel wall region and the average signal from an adjacent myocardial area. Such metric is used to classify hyper-intense plaques, also known as "hot spots", which has PMR over 1.0.

  Day 1

Secondary Outcomes (1)

• Stenosis level (patient group only)

  Day 1

Study Arms (2)

Healthy Volunteers

OTHER

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.

Device: Cardiac MRI; Drug: Contrast; Drug: Beta blocker

Coronary Artery Disease (CAD) Patients

OTHER

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.

Device: Cardiac MRI; Drug: Contrast; Drug: Beta blocker

Interventions

Cardiac MRI DEVICE

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

Also known as: Magnetic Resonance Imaging

Coronary Artery Disease (CAD) Patients; Healthy Volunteers

Contrast DRUG

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

Also known as: contrast agent, Gadavist

Coronary Artery Disease (CAD) Patients; Healthy Volunteers

Beta blocker DRUG

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.

Also known as: Metoprolol

Coronary Artery Disease (CAD) Patients; Healthy Volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Cedars-Sinai Medical Center: lead

Study Sites (1)

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

RECRUITING

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Magnetic Resonance Imaging; Contrast Media; gadobutrol; Adrenergic beta-Antagonists; Metoprolol

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Tomography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Adrenergic Antagonists; Adrenergic Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Phenoxypropanolamines; Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines

Study Officials

• Debiao Li, PhD

  Cedars-Sinai Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rosalia (Sally) A De Leon

CONTACT

310 423-7758; Rosalia.DeLeon@cshs.org

Debiao Li, PhD

CONTACT

310 423-7743; debiao.li@cshs.org

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Biomedical Imaging Research Institute

Study Record Dates

• First Submitted: March 19, 2018
• First Posted: April 20, 2018
• Study Start: July 30, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2026
• Last Updated: August 14, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)