NCT03504956

Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 150 (estimated)
• Sponsor: Cedars-Sinai Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Detailed description

Approximately 110 healthy male/female adult "normals" or "controls" and 40 male/female adult outpatients who are suspected of having or have been diagnosed with coronary artery disease will be recruited. All subjects will be asked to undergo either a non-contrast MRI or a contrast-enhanced MRI of the coronary artery depending upon the focus of development at the time of their participation It is anticipated that healthy volunteers will undergo non-contrast or contrast-enhanced MRI for evaluating the image quality associated with each acquisition module of the developed technique and motion artifact associated with motion compensation strategy. For subjects receiving contrast, a total dose of up to 0.2 mmol/kg of a gadolinium based contrast agent will be injected intravenously provided all the safety requirements are met. Subjects undergoing a contrast-enhanced MRI will be screened using the standard clinical protocol to determine whether it is safe to administer contrast. If subjects do not qualify for contrast administration, they may be asked to have a research scan without contrast. Research MRI results will be compared with clinical diagnostic CT and/or invasive imaging studies for patients who have been evaluated with these exams at Cedars-Sinai Medical Center..

Conditions

• Coronary Atherosclerosis

Interventions

Type	Name	Description
DEVICE	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.
DRUG	Contrast	The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).
DRUG	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.

Timeline

• Start date: 2018-07-30
• Primary completion: 2025-12-31
• Completion: 2026-12-31
• First posted: 2018-04-20
• Last updated: 2025-08-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study