NCT04882488Recruiting
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
Source: ClinicalTrials.gov · Last updated 26 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 20 (estimated)
- First submitted
- 6 May 2021
- Start date
- 1 Jun 2021
- Primary completion date
- 30 Jun 2025
- Lead sponsor
- Heart and Diabetes Center North-Rhine Westfalia
- Diseases
- Coronary artery disease
- NCT number
- NCT04882488
What you commit to
- Study type: Observational
- Planned participants: 20
- From 1 Jun 2021 to the primary completion date, 30 Jun 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Lab values
- left ventricular ejection fraction \< 55%
Other
- intolerance of Adenosin
Who the study is looking for
- 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
Age in the registry: 65 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Save your city in your profile to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Herz- und Diabeteszentrum NRW Coordinator of this site? Confirm its status | Bad Oeynhausen | Germany | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.