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

NCT ID: NCT04882488

Last Updated: 2024-11-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-06-01

Study Completion Date

2025-09-30

Brief Summary

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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.

Detailed Description

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Conditions

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Aortic Valve Stenosis Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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%
Minimum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Heart and Diabetes Center North-Rhine Westfalia

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Tanja Rudolph, MD

Role: PRINCIPAL_INVESTIGATOR

Consultant physician

Locations

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Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, Germany

Site Status RECRUITING

Countries

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Germany

Central Contacts

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Tanja Rudolph, MD

Role: CONTACT

+495731971258

Astrid Kleemeyer

Role: CONTACT

+49495731971258

Facility Contacts

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Tanja K Rudolph, MD

Role: primary

00495731971258

Other Identifiers

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HDZ-KA_020_TR

Identifier Type: -

Identifier Source: org_study_id

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