Coronary Atherosclerosis Clinical Trial
— CATCHOfficial title:
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)
NCT number | NCT03504956 |
Other study ID # | 45312 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | July 30, 2018 |
Est. completion date | December 31, 2026 |
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.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | December 31, 2026 |
Est. primary completion date | December 31, 2025 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Cedars-Sinai Medical Center | Los Angeles | California |
Lead Sponsor | Collaborator |
---|---|
Cedars-Sinai Medical Center |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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. | Day 1 |
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