Evaluating Resting Full-cycle Ratio in Side Branch Lesions
PRospEctive Evaluation of DIagnostiC Performances of resTing Full-cycle rAtio in Coronary Bifurcation LEsion (PREDICTABLE Study)
This study is testing if a new way to measure blood flow can help doctors better understand side branch heart artery problems in patients with coronary artery disease without needing extra medications.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 286 (estimated) |
| Ages | 20 Years to 90 Years |
| Sex | All |
| Sponsor | Sejong General Hospital Academic / other |
| Locations | 1 site (Bucheon, Gyeonggi-do) |
| Trial ID | NCT06075173 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the diagnostic performance of the resting full-cycle ratio (RFR) in patients with side branch lesions compared to main vessel lesions. It will involve measuring RFR and fractional flow reserve (FFR) to determine the functional significance of these lesions in patients with coronary artery disease. The study seeks to establish whether RFR can provide accurate assessments without the need for hyperemic agents, which are typically required for FFR measurements. By focusing on the real-world application of RFR, the study hopes to improve the management of coronary artery disease and reduce unnecessary interventions.
Who should consider this trial
Good fit: Ideal candidates include patients with side branch lesions requiring functional evaluation.
Not a fit: Patients with severe left ventricular systolic dysfunction or those with acute coronary syndrome may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing ischemia in patients with coronary artery disease, leading to better-targeted treatments.
How similar studies have performed: Previous studies have shown that similar approaches using instantaneous flow ratio (iFR) have been successful, indicating potential for RFR as a viable alternative.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients with side branch lesion, who need functional evaluation Exclusion Criteria: * Severe LV systolic dysfunction (LVEF \<30%) * Culprit vessel in acute coronary syndrome * Donor vessel to supply chronic total occlusion lesion of non-target vessel * Symptomatic valvular heart disease or cardiomyopathy * Too much overlapping or severe tortuosity to disrupt quantitative coronary analysis * Previous bypass surgery
Where this trial is running
Bucheon, Gyeonggi-do
- Sejong General Hospital — Bucheon, Gyeonggi-do, Korea, Republic of (Recruiting)
Study contacts
- Study coordinator: Hyun-Jong Lee, MD, PhD
- Email: untouchables00@hanmail.net
- Phone: 82-10-6217-9315
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.