NCT04882488 Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis
| NCT ID | NCT04882488 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Heart and Diabetes Center North-Rhine Westfalia |
| Condition | Aortic Valve Stenosis |
| Study Type | OBSERVATIONAL |
| Enrollment | 20 participants |
| Start Date | 2021-06-01 |
| Primary Completion | 2025-06-30 |
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 20 participants in total. It began in 2021-06-01 with a primary completion date of 2025-06-30.
⚠ 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
Aortic valve stenosis (AS) affects 2-7% of persons \> 65 years, symptoms include: angina and dyspnea, dizziness and syncope. Coincidence of coronary artery disease (CAD), also presenting with angina and dyspnea, in patients with AS between 40 - 65% . Angina in AS caused by significant reduction of coronary flow reserve (CFR). CFR is the ratio of maximal flow increase in the coronary vessel bed during maximal hyperaemia (medically or exercise induced). FFR (fractional flow reserve) use in patients with AS potentially invalid due to dysfunctional CFR leading to potential undertreatment of CAD in these patients.CFR disturbance in AS mainly due to myocardial overload causing concentric hypertrophy, increased oxygen consumption and neurohormonal activation leading to increased vascular resistance. Current studies are investigating the validity of FFR and iFR in AS patients. Recent data demonstrate very good correlation between FFR and iFR derived values to PET myocardial perfusion imaging values in patients with no evidence of AS. Our study aims to investigate the diagnostic performance of FFR and iFR in intermediate-grade coronary stenosis in patients with severe aortic valve disease and correlate FFR- and iFR derived values with those extracted from PET-perfusion Imaging.
Eligibility 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%
Contact & Investigator
Tanja Rudolph, MD
PRINCIPAL INVESTIGATOR
Consultant physician
Frequently Asked Questions
Who can join the NCT04882488 clinical trial?
This trial is open to participants of all sexes, aged 65 Years or older, studying Aortic Valve Stenosis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04882488 currently recruiting?
Yes, NCT04882488 is actively recruiting participants. Contact the research team at trudolph@hdz-nrw.de for enrollment information.
Where is the NCT04882488 trial being conducted?
This trial is being conducted at Bad Oeynhausen, Germany.
Who is sponsoring the NCT04882488 clinical trial?
NCT04882488 is sponsored by Heart and Diabetes Center North-Rhine Westfalia. The principal investigator is Tanja Rudolph, MD at Consultant physician. The trial plans to enroll 20 participants.