Clinical Trial

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

Study acronym: TAVI PET
Recruiting
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Record status
This record was last updated November 26, 2024 (before its estimated June 30, 2025 completion). Its status may not reflect the trial's current state.
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.
Protocol Amendment History 3 amendments
This ClinicalTrials.gov record has been amended 3 times since 2021-05-11; most recent amendment 2024-11-22.
Status change: Not Yet Recruiting → Recruiting 2022-08-08
Trial Details
NCT Number NCT04882488
Lead Sponsor Heart and Diabetes Center North-Rhine Westfalia
Conditions Aortic Valve Stenosis, Coronary Artery Disease
Enrollment 20 participants
Start Date 2021-06-01
Primary Completion 2025-06-30 (estimated)
Study Completion 2025-09-30 (estimated)
Updated on ClinicalTrials.gov 2024-11-26