Brief Title
Correlation of FFR and iFR With Cardiac PET Perfusion in Patients With Severe Aortic Valve Stenosis
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
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.
Study Type
Observational
Primary Outcome
Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure
Secondary Outcome
Clinical Evaluation Prior to and following TAVI
Condition
Aortic Valve Stenosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Estimated Enrollment
20
Start Date
June 1, 2021
Completion Date
June 30, 2024
Primary Completion Date
December 31, 2023
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%
Gender
All
Ages
65 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Tanja Rudolph, MD, +495731971258, [email protected]
Location Countries
Germany
Location Countries
Germany
Administrative Informations
NCT ID
NCT04882488
Organization ID
HDZ-KA_020_TR
Responsible Party
Sponsor
Study Sponsor
Heart and Diabetes Center North-Rhine Westfalia
Study Sponsor
Tanja Rudolph, MD, Principal Investigator, Consultant physician
Verification Date
August 2022