Evaluating the Prognostic Value of Hemodynamic Indices in Coronary Artery Disease
Prognostic Impact of Lesion-specific Hemodynamic Index and Disease Characteristics in Patients With Coronary Artery Disease Assessed by Fractional Flow Reserve
This study is testing if certain blood flow measurements can help predict how well patients with coronary artery disease will do after a heart procedure.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2429 (estimated) |
| Ages | 20 Years and up |
| Sex | All |
| Sponsor | Seoul National University Hospital Academic / other |
| Locations | 1 site (Seoul) |
| Trial ID | NCT05250557 on ClinicalTrials.gov |
What this trial studies
This study investigates the prognostic value of lesion-specific hemodynamic indices, such as ΔFFR and RFR, in patients with coronary artery disease. It aims to assess how these indices, alongside traditional measures like % diameter stenosis and FFR, can improve risk prediction for patients undergoing percutaneous coronary intervention (PCI). The study will also explore the implications of post-PCI FFR in conjunction with various clinical and disease characteristics to develop a comprehensive risk prediction model. By doing so, it seeks to enhance the understanding of local hemodynamics in predicting patient outcomes.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 20 years and older who have undergone successful FFR measurement.
Not a fit: Patients with chronic renal failure, recent ST-elevation myocardial infarction, or significant heart conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved risk stratification and treatment outcomes for patients with coronary artery disease undergoing PCI.
How similar studies have performed: While the use of FFR in clinical practice is established, this specific approach to evaluating ΔFFR and RFR in a prospective manner is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age ≥20 years 2. All comers who underwent successful FFR measurement and pullback tracing Exclusion Criteria: 1. Chronic renal failure (estimated glomerular filtration rate \<30) 2. ST-elevation myocardial infarction within 72 hours or previous coronary artery bypass graft surgery history 3. Primary myocardial or valvular disease 4. Left ventricular ejection fraction \< 30% 5. Hemodynamically unstable clinical conditions 6. Life expectancy \< 2 years
Where this trial is running
Seoul
- Seoul National University Hospital — Seoul, South Korea (Recruiting)
Study contacts
- Principal investigator: Bon-Kwon Koo, MD, PhD — Seoul National University Hospital
- Study coordinator: Bon-Kwon Koo, MD, PhD
- Email: bkkoo@snu.ac.kr
- Phone: +82-2-2072-2062
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.