Examining heart blood flow in patients with severe aortic valve narrowing
Correlation of FFR and iFR With Cardiac PET Perfusion (at Rest and Under Adenosine) in the Evaluation of Intermediate Coronary Stenoses in Patients With Severe Aortic Valve Stenosis
This study tests how two heart flow measurements can help doctors understand and treat patients with severe aortic valve narrowing and coronary artery disease.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 20 (estimated) |
| Ages | 65 Years and up |
| Sex | All |
| Sponsor | Heart and Diabetes Center North-Rhine Westfalia Academic / other |
| Locations | 1 site (Bad Oeynhausen, North Rhine-Westphalia) |
| Trial ID | NCT04882488 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the relationship between fractional flow reserve (FFR) and instantaneous wave-free ratio (iFR) with cardiac PET perfusion imaging in patients suffering from severe aortic valve stenosis. The study aims to understand how these measurements correlate with coronary artery disease, which is common in patients with aortic stenosis. By evaluating patients who are eligible for transcatheter aortic valve replacement, the study seeks to determine the effectiveness of FFR and iFR in assessing coronary flow reserve and guiding treatment decisions. The findings could help improve the management of patients with concurrent aortic stenosis and coronary artery disease.
Who should consider this trial
Good fit: Ideal candidates for this study are patients over 65 years old with severe aortic stenosis and a left ventricular ejection fraction greater than 55%.
Not a fit: Patients who have a left ventricular ejection fraction below 55% or intolerance to adenosine may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the accuracy of diagnosing and treating coronary artery disease in patients with severe aortic valve stenosis.
How similar studies have performed: Other studies have shown promising correlations between FFR, iFR, and myocardial perfusion imaging in similar patient populations, suggesting that this approach is supported by existing research.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * patients with severe aortic Stenosis eligible for transcatheter aortic stenosis * left ventricular ejection fraction \> 55% * no intolerance of Adenosin * no history of bradycardia, atrioventricular Blockade * intermediate coronary Stenosis with FFR\> 0.8 * Age \>65 Exclusion Criteria: * intolerance of Adenosin * left ventricular ejection fraction \< 55%
Where this trial is running
Bad Oeynhausen, North Rhine-Westphalia
- Herz- und Diabeteszentrum, NRW — Bad Oeynhausen, North Rhine-Westphalia, Germany (Recruiting)
Study contacts
- Principal investigator: Tanja Rudolph, MD — Consultant physician
- Study coordinator: Tanja Rudolph, MD
- Email: trudolph@hdz-nrw.de
- Phone: +495731971258
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.