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

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

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 Overview

• Status: Recruiting
• Conditions: Coronary Artery Disease; Aortic Valve Stenosis

• Study Type: Observational
• Enrollment (Estimated): 20

Contacts and Locations

• Study Contact: Name: Tanja Rudolph, MD; Phone Number: +495731971258; Email: trudolph@hdz-nrw.de
• Study Contact Backup: Name: Astrid Kleemeyer; Phone Number: +49495731971258; Email: akleemeyer@hdz-nrw.de

Study Locations

• Germany
  • NRW
    • Bad Oeynhausen, NRW, Germany, 32545
      • Recruiting
      • Herz- und Diabeteszentrum, NRW
      • Contact: Tanja K Rudolph, MD; Phone Number: 00495731971258; Email: trudolph@hdz-nrw.de

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 65 years and older (Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with severe aortic Stenosis eligible for transcatheter aortic Valve Implantation (TAVI) with concurring coronary artery disease.

Description

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%

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical Evaluation Prior to and following TAVI	Angina prevalence in patients with intermediate coronary Stenosis Prior to and 3 months following TAVI	3 months

Collaborators and Investigators

• Sponsor: Heart and Diabetes Center North-Rhine Westfalia
• Investigators: Principal Investigator: Tanja Rudolph, MD, Consultant physician

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2021
• Primary Completion (Estimated): December 31, 2023
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: May 6, 2021
• First Submitted That Met QC Criteria: May 11, 2021
• First Posted (Actual): May 12, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2024
• Last Update Submitted That Met QC Criteria: January 9, 2024
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: coronary artery disease; Aortic valve stenosis; FFR; PET-CT
• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Artery Disease; Myocardial Ischemia; Coronary Disease; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: HDZ-KA_020_TR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No