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NCT03504956NARecruitingAccepts Healthy Volunteers

Coronary Atherosclerosis T1-Weighted Characterization (CATCH)

Cedars-Sinai Medical Center

Start Date

7/30/2018

Completion Date

12/31/2026

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..

Eligibility Criteria

Age Range: 18 years to No maximum

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

Interventions

DEVICE

Cardiac MRI

DRUG

Contrast

DRUG

Beta blocker

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Conditions

Coronary Atherosclerosis

Locations

Cedars-Sinai Medical Center

Los Angeles, California 90048

United States