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

NCT04882488 | Recruiting

• 1 other identifier: HDZ-KA_020_TR
• Study Type: observational
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Clinical Evaluation Prior to and following TAVI

  3 months

Eligibility Criteria

• Age: 65 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• intolerance of Adenosin
• left ventricular ejection fraction \< 55%

Sponsors & Collaborators

• Heart and Diabetes Center North-Rhine Westfalia: lead

Study Sites (1)

Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

RECRUITING

Biospecimen

Retention: NONE RETAINED

NT pro BNP,

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Tanja Rudolph, MD

  Consultant physician

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tanja Rudolph, MD

CONTACT

+495731971258; trudolph@hdz-nrw.de

Astrid Kleemeyer

CONTACT

+49495731971258; akleemeyer@hdz-nrw.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2021
• First Posted: May 12, 2021
• Study Start: June 1, 2021
• Primary Completion: June 30, 2025
• Study Completion: September 30, 2025
• Last Updated: November 26, 2024

Record last verified: 2024-11

Locations

DE (1)