Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis

NCT04882488 · tracked via the Priya Life Science Germany tracker

Sponsor

Heart and Diabetes Center North-Rhine Westfalia

Phase

Observational

Started

2021-06-01

Last updated

2024-11-26

Condition(s) studied

Aortic Valve StenosisCoronary Artery Disease

Study 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

Sex

ALL

Min age

65 Years

Max age

—

Healthy volunteers

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%

Primary outcome measure(s)

Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure — 3 months
Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI

Trial sites (1)

Facility	City	Region	Status
Herz- und Diabeteszentrum, NRW	Bad Oeynhausen	North Rhine-Westphalia	Recruiting

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Other trials for the same condition

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04882488 on ClinicalTrials.gov ↗ ← All trials in Germany