NCT06255678 Angio-based Final Functional Effect of PCI
| NCT ID | NCT06255678 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Medical University of Warsaw |
| Condition | Acute Coronary Syndrome |
| Study Type | OBSERVATIONAL |
| Enrollment | 2,005 participants |
| Start Date | 2023-07-03 |
| Primary Completion | 2027-01-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 2,005 participants in total. It began in 2023-07-03 with a primary completion date of 2027-01-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
Fractional flow reserve (FFR) has revolutionized the diagnosis and treatment of coronary artery disease (CAD), and more recently, post percutaneous coronary intervention (post-PCI) FFR has emerged as an independent predictor of cardiovascular events, enabling the identification of cases requiring additional optimization of the implanted stent. Modern technologies allow less invasive alternatives to traditional FFR measurement - angiography-based vessel fractional flow reserve (vFFR) and derivative ΔvFFR, which is calculated by a difference between the post-PCI vFFR and pre-PCI vFFR. In large clinical studies, the good accuracy between vFFR and FFR - measured before and after PCI - has been confirmed. However, insufficient data is available about the value of post-vFFR and ΔvFFR as prognostic values and indicators of patient health. This is a prospective multicenter register study analyzing the association between the value of ΔvFFR, vFFR after PCI and adverse clinical outcomes, residual angina and quality of life using the validated Seattle Angina Questionnaire (SAQ) and EuroQol 5-level 5-dimensional questionnaire (EQ-5D-5L). Patients undergoing PCI for chronic coronary syndromes (CCS), non-ST-segment elevation acute coronary syndromes (NST-ACS) or ST-Segment Elevation Myocardial Infarction (STEMI) will be enrolled in this study.
Eligibility Criteria
Inclusion Criteria: * Percutaneous coronary intervention (PCI) for chronic coronary syndromes (CCS) or acute coronary syndromes (ACS) * Adequate quality of angiogram enabling vFFR analysis (available two angiographic views with ≥30° differences in rotation/angulation, the possibility of vessel contour selection, proper quality of the images, vessels without severe overlapping, tortuosity, foreshortening and poor vessel opacification) * Age \>18 years * The patient's written informed consent has been obtained before the procedure Exclusion Criteria: * Cardiogenic shock, pulmonary oedema * Severe hemodynamical instability * Prior coronary artery bypass grafting (CABG) * Active bleeding * Acute and chronic inflammatory conditions * Acute mechanical complications of myocardial infarction * Congenital heart disease * Heart transplantation * Non-cardiac comorbidities with a life expectancy of less than 1 year
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06255678 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Acute Coronary Syndrome. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06255678 currently recruiting?
Yes, NCT06255678 is actively recruiting participants. Contact the research team at mariusz.tomaniak@wum.edu.pl for enrollment information.
Where is the NCT06255678 trial being conducted?
This trial is being conducted at Warsaw, Poland.
Who is sponsoring the NCT06255678 clinical trial?
NCT06255678 is sponsored by Medical University of Warsaw. The trial plans to enroll 2,005 participants.