What this study is
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.
What's being tested
- Cardiac MRI
Intervention · 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
Intervention · DRUG
The intravenous gadolinium based contrast agent to be used in this study is Gadavist (up to 0.2 mmol/kg).
- Beta blocker
Intervention · 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.
Study details
- Sponsor
- Cedars-Sinai Medical Center
- Conditions
- Coronary Atherosclerosis
- Enrolling
- 150 people
- Starts
- 2018-07-30
- Est. completion
- 2027-12-31
- Design
- Open-label, non-randomized, single group
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers AcceptedYou 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 can't join 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
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (1)
1 openCedars-Sinai Medical Center
Los Angeles, California, United States
- Rhona Littman · Contact310-423-4387Rhona.Littman@cshs.org
- Debiao Li, PhD · Contact310 423-7743Debiao.Li@cshs.org
Recruiting
Study team
Sponsor
Cedars-Sinai Medical Center
Study ID 45312
Principal investigator
Debiao Li, PhD
Cedars-Sinai Medical Center
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.