New MRI technique for evaluating coronary atherosclerosis
Coronary Atherosclerosis T1-Weighted Characterization (CATCH)
This study is testing a new MRI method to see if it can better and faster help doctors check for heart artery problems in healthy people and those who might have heart disease.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Cedars-Sinai Medical Center Academic / other |
| Locations | 1 site (Los Angeles, California) |
| Trial ID | NCT03504956 on ClinicalTrials.gov |
What this trial studies
This study aims to develop a novel MRI technique called Coronary Atherosclerosis T1-weighted Characterization (CATCH) to enhance the evaluation of coronary atherosclerosis. It will involve approximately 100 healthy volunteers and 40 patients suspected of having coronary artery disease, who will undergo either non-contrast or contrast-enhanced MRI scans. The study will assess the image quality and motion artifacts associated with the new technique and compare the results with existing diagnostic methods. The goal is to simplify the scanning process and reduce imaging time compared to traditional methods.
Who should consider this trial
Good fit: Ideal candidates include healthy adults aged 18 and older with no history of cardiovascular disease and patients who are medically stable and suspected of having coronary artery disease.
Not a fit: Patients with contraindications to MRI, such as certain implants or severe allergies to gadolinium-based contrast agents, may not benefit from this study.
Why it matters
Potential benefit: If successful, this technique could provide a more reliable and efficient way to evaluate coronary atherosclerosis, leading to better patient outcomes.
How similar studies have performed: Other studies have shown promise in using advanced MRI techniques for cardiovascular evaluation, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Los Angeles, California
- Cedars-Sinai Medical Center — Los Angeles, California, United States (Recruiting)
Study contacts
- Principal investigator: Debiao Li, PhD — Cedars-Sinai Medical Center
- Study coordinator: Rosalia (Sally) A De Leon
- Email: Rosalia.DeLeon@cshs.org
- Phone: 310 423-7758
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.