Using a dynamic roadmap system to guide heart artery pressure measurements
Impact of Dynamic CoROnary RoADmap System for Guidance of Instantaneous Wave-Free Ratio or Fractional Flow Reserve: A Single-Center, Randomized Study (ROAD-IFR Trial)
This study is testing a new system that uses advanced software to help doctors measure heart artery pressure more accurately during procedures for patients with chest pain or heart issues.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 226 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Yonsei University Academic / other |
| Locations | 1 site (Yongin, Gyeonggi-do) |
| Trial ID | NCT05682118 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of a dynamic coronary roadmap system during coronary angiography in patients with significant coronary artery stenosis. It aims to improve the accuracy and efficiency of measuring fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) by utilizing advanced software to visualize the coronary anatomy. Patients with stable angina or acute coronary syndrome will be included, and the study will assess how the roadmap can enhance the procedural outcomes compared to traditional methods. The goal is to determine if this innovative approach can streamline the evaluation process and improve patient management.
Who should consider this trial
Good fit: Ideal candidates include adults aged 19 and older with stable angina or acute coronary syndrome and 50-90% stenosis in coronary arteries.
Not a fit: Patients with single vessel disease, previous coronary artery bypass grafting, or poor coronary blood flow may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to more accurate assessments of coronary artery disease, potentially improving treatment decisions and patient outcomes.
How similar studies have performed: While there are no prior studies specifically evaluating the dynamic roadmap system in this context, similar approaches using advanced imaging techniques have shown promise in improving coronary assessments.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients aged 19 years or older 2. Patients with stable angina, including asymptomatic ischemic heart disease, who have 50-90% stenosis of the causative vessel by coronary angiography 3. Acute coronary syndrome patients with multivessel disease and 50-90% stenosis of non-caused vessels that did not cause acute coronary syndrome 4. Patients who voluntarily decided to participate in this study and gave written consent to the subject consent form Exclusion Criteria: 1. Patients with acute coronary syndrome and single vessel disease 2. Patients who have undergone previous coronary artery bypass grafting 3. Poor coronary blood flow (TIMI grade ≤ 2) 4. If life expectancy is less than one year 5. Women who are pregnant or wish to become pregnant
Where this trial is running
Yongin, Gyeonggi-do
- Yongcheol Kim — Yongin, Gyeonggi-do, South Korea (Recruiting)
Study contacts
- Principal investigator: Yongcheol Kim, MD, PhD — Severance Hospital
- Study coordinator: Yongcheol Kim, MD, PhD
- Email: yongcheol@yuhs.ac
- Phone: +823151898967
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.