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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04882488

Acronym

TAVI PET

Enrollment

Registered

2021-05-12

Start date

2021-06-01

Completion date

2025-09-30

Last updated

2024-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Aortic Valve Stenosis, Coronary Artery Disease

Keywords

Aortic valve stenosis, PET-CT, coronary artery disease, FFR

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

65 Years to No maximum

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%

Design outcomes

Primary

Measure	Time frame	Description
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

Secondary

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

Countries

Germany

Contacts

Primary ContactTanja Rudolph, MD

trudolph@hdz-nrw.de+495731971258

Backup ContactAstrid Kleemeyer

akleemeyer@hdz-nrw.de+49495731971258

Outcome results