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

Coronary Artery Disease Clinical Trial

— TAVI PET  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04882488
• Other study ID #: HDZ-KA_020_TR
• Status: Recruiting
• Start date: June 1, 2021
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: Heart and Diabetes Center North-Rhine Westfalia
• Contact: Tanja Rudolph, MD
• Phone: +495731971258
• Email: trudolph[@]hdz-nrw.de
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: June 30, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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%

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Locations

Country	Name	City	State
Germany	Herz- und Diabeteszentrum, NRW	Bad Oeynhausen	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heart and Diabetes Center North-Rhine Westfalia

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure	Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI	3 months
Secondary	Clinical Evaluation Prior to and following TAVI	Angina prevalence in patients with intermediate coronary Stenosis Prior to and 3 months following TAVI	3 months