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NCT Number: NCT04882488

Correlation of FFR and iFR With Cardiac PET Perfusion 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.

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Key information

Age range

65 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Herz- und Diabeteszentrum, NRW

Bad Oeynhausen, North Rhine-Westphalia, 32545, Germany

Location status: Recruiting

Location contact

Tanja K Rudolph, MD

CONTACT

[email protected]

00495731971258

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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%

Treatment and study plan

Primary outcomes

  1. Correlation of PET-CT Prior to TAVI and 3 months after TAVI procedure

    Time frame: 3 months

    Evaluation of FFR-negative intermediary coronary stenoses in Patients with severe Aortic Stenosis Prior and 3 months following TAVI

Secondary outcomes

  1. Clinical Evaluation Prior to and following TAVI

    Time frame: 3 months

    Angina prevalence in patients with intermediate coronary Stenosis Prior to and 3 months following TAVI

Study contacts

Contact information is provided by the study sponsor or research team.

Astrid Kleemeyer

CONTACT

[email protected]

+49495731971258

Tanja Rudolph, MD

CONTACT

[email protected]

+495731971258

Sponsors and collaborators

Lead sponsor

Heart and Diabetes Center North-Rhine Westfalia

Other

Registry information

Official study 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

Acronym: TAVI PET

Important dates

Study start
2021
Primary completion
2025
Study completion
2025
First posted
May 12, 2021
Registry last updated
Nov 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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