Status:
COMPLETED
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
Lead Sponsor:
Universitaire Ziekenhuizen KU Leuven
Collaborating Sponsors:
AZ Delta
University Hospital, Antwerp
Conditions:
Aortic Stenosis
Coronary Artery Disease
Eligibility:
All Genders
18+ years
Brief Summary
Although concomitant coronary artery disease (CAD) is frequent in patients with severe aortic stenosis (AS), hemodynamic assessment of CAD severity in patients undergoing valve replacement for severe ...
Detailed Description
https://journals.physiology.org/doi/full/10.1152/ajpheart.00541.2021?rfr\_dat=cr\_pub++0pubmed\&url\_ver=Z39.88-2003\&rfr\_id=ori%3Arid%3Acrossref.org
Eligibility Criteria
Inclusion
- 1\. Patient undergoing the procedure is older than 18 years, has severe aortic valve stenosis (according to ESC guidelines) and is planned for cardiac catheterization as part of the pre-operative (SAVR) or pre-percutaneous (TAVI) work up.
- 2\. The patient has an intermediate (50-90%) coronary lesion that requires further evaluation.
- 3\. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.
Exclusion
- The procedure is an emergency and/or the patient is unstable.
- Pregnancy or lactation
- Haemodynamically unstable patients
- Killip class III-IV heart failure
- Previous coronary artery by-pass in the artery being assessed
- Contra-indications for adenosine administration: severe asthma or pre-existing type 2 AV-block
- No significant coronary artery disease (\<50% stenosis on angiography).
- Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
- Patients will be excluded from the SPECT study (secondary objective) if they have a left main coronary stenosis \>50%, triple vessel disease, previous myocardial infarction in the same coronary artery \& tandem lesions (separated by \>10mm) requiring independent evaluation in the same coronary artery since these factors interfere with the SPECT analysis.
Key Trial Info
Start Date :
June 1 2020
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 1 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04420325
Start Date
June 1 2020
End Date
October 1 2024
Last Update
September 5 2025
Active Locations (3)
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1
UZ Leuven
Leuven, Vlaams-brabant, Belgium, 3000
2
University hospital Antwerp
Antwerp, Belgium
3
AZ Delta
Roeselare, Belgium