Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

ConditionCoronary Atherosclerosis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorCedars-Sinai Medical Center

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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

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.

Disqualifiers

None

Trial design

Design model

Single group

Treatments tested in this trial

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

Treatment groups

150 Participants

are divided into 2 treatment groups

Group A: Healthy VolunteersOther 3 interventions

Group B: Coronary Artery Disease (CAD) PatientsOther 3 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Day 1

Secondary outcomes

Stenosis level (patient group only)

Stenosis level will be evaluated at the vascular segments with visible lumen narrowing in each patient. The extent of a stenosis will be measured and recorded as a percentage, ranging from 0% to 100%, with 100% representing a complete occlusion.

Time frame

Day 1

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Cedars-Sinai Medical Center

Lead sponsor

Source ClinicalTrials.gov

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