Assessing the significance of severe coronary artery blockages before PCI
Physiological Assessment of Severe Coronary Stenosis for Informing Planned PCI (REFINE PCI)
Beth Israel Deaconess Medical Center · NCT05491668
This study is testing if a new way of measuring blood flow can help doctors better understand the impact of severe blockages in heart arteries before and after a procedure called PCI.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 107 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Beth Israel Deaconess Medical Center (other) |
| Locations | 1 site (Boston, Massachusetts) |
| Trial ID | NCT05491668 on ClinicalTrials.gov |
What this trial studies
This study investigates the physiological significance of coronary lesions that are visually assessed as severely blocked and are planned for percutaneous coronary intervention (PCI). It employs blinded physiological assessments both before and after the PCI procedure to determine the actual impact of these lesions on blood flow. The study aims to enhance the understanding of how invasive physiological testing can improve outcomes in patients undergoing PCI, particularly for lesions deemed severe by traditional angiographic methods. By utilizing advanced pressure-sensing technology, the study seeks to validate the effectiveness of non-hyperemic pressure ratio assessments in this context.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with stable coronary artery disease or acute coronary syndromes who are scheduled for cardiac catheterization and have at least one lesion visually estimated to be 70% or more blocked.
Not a fit: Patients with acute ST Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) as the culprit vessel, or those with chronic total occlusions, may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved patient outcomes by ensuring that only truly significant blockages are treated during PCI.
How similar studies have performed: Previous studies have shown success with physiology-guided PCI approaches, indicating that this study builds on established findings rather than exploring a completely novel concept.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Age \>/= 18 years * Patient provides written informed consent * Clinical presentation with stable coronary artery disease or acute coronary syndromes (unstable angina, Non-ST Elevation Myocardial Infarction (NSTEMI), or ST Elevation Myocardial Infarction (STEMI)) * Scheduled for clinically indicated cardiac catheterization * At least one lesion with angiographic severity visually estimated to be \>/= 70% diameter stenosis that is deemed suitable for PCI * The operator plans to perform PCI on an ad hoc or planned basis * The target lesion is not planned for assessment by invasive physiology Exclusion Criteria: * Failure to provide signed informed consent * Culprit vessel of acute ST Elevation Myocardial Infarction (STEMI) * Culprit vessel of Non-ST Elevation Myocardial Infarction (NSTEMI) * Thrombolysis In Myocardial Infarction (TIMI) flow less than grade 3 at baseline or visible thrombus * Chronic total occlusion (CTO) in the target vessel * Target vessel is supplied by major collaterals or supplies major collaterals to a CTO * Target lesion involves the left main coronary artery * Prior history of coronary artery bypass grafting (CABG) to the target vessel, except if bypass graft is occluded * Previously known untreated severe valvular heart disease * Previously known left ventricular ejection fraction \<30% * Sustained ventricular arrhythmias * Patients who are currently pregnant (pregnancy testing will be performed as per standard cardiac catheterization laboratory protocol)
Where this trial is running
Boston, Massachusetts
- Beth Israel Deaconess Medical Center — Boston, Massachusetts, United States (RECRUITING)
Study contacts
- Principal investigator: Eric Osborn, MD, PhD — Beth Israel Deaconess Medical Center
- Study coordinator: Eric Osborn, MD, PhD
- Email: eosborn@bidmc.harvard.edu
- Phone: 617-632-7452
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.
Conditions: Coronary Artery Disease, Invasive physiology, Angiography, Percutaneous coronary intervention