COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

Active, not recruiting

• Conditions: Aortic Stenosis; Coronary Artery Disease

• Registration Number: NCT04420325
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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 AS is challenging. Myocardial hypertrophic remodeling interferes with coronary blood flow and may influence the values of fractional flow reserve (FFR) and nonhyperemic pressure ratios (NHPRs). The aim of the current study is to investigate the effect of the AS and its treatment on current indices used for evaluation of CAD. The investigators will compare intracoronary hemodynamics before, immediately after, and 6 mo after aortic valve replacement (AVR) when it is expected that microvascular function has improved. Furthermore, the investigators will compare FFR and resting full-cycle ratio (RFR) with myocardial perfusion single-photon emission-computed tomography (SPECT) as indicators of myocardial ischemia in patients with AS and CAD. One-hundred consecutive patients with AS and intermediate CAD will be prospectively included. Patients will undergo pre-AVR SPECT and intracoronary hemodynamic assessment at baseline, immediately after valve replacement \[if transcatheter AVR (TAVR) is chosen\], and 6 mo after AVR. The primary end point is the change in FFR 6 mo after AVR. Secondary end points include the acute change of FFR after TAVR, the diagnostic accuracy of FFR versus RFR compared with SPECT for the assessment of ischemia, changes in microvascular function as assessed by the index of microcirculatory resistance (IMR), and the effect of these changes on FFR. The present study will evaluate intracoronary hemodynamic parameters before, immediately after, and 6 mo after AVR in patients with AS and intermediate coronary stenosis. The understanding of the impact of AVR on the assessment of FFR, NHPR, and microvascular function may help guide the need for revascularization in patients with AS and CAD planned for AVR.

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

Study Timeline

• Study Start: 2020-06-01
• Study First Submitted: 2020-06-03
• Study First Submitted QC: 2020-06-03
• Study First Posted: 2020-06-09
• Status Verified: 2024-04
• Primary Completion: 2024-04-01
• Last Update Submitted: 2024-04-04
• Last Update Posted: 2024-04-09
• Study Completion: 2024-07-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 116

Inclusion Criteria

• 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 Criteria

1. The procedure is an emergency and/or the patient is unstable.
2. Pregnancy or lactation
3. Haemodynamically unstable patients
4. Killip class III-IV heart failure
5. Previous coronary artery by-pass in the artery being assessed
6. Contra-indications for adenosine administration: severe asthma or pre-existing type 2 AV-block
7. No significant coronary artery disease (<50% stenosis on angiography).
8. Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
9. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
FFR 6 months after SAVR/TAVI.	6 months	Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI.

Secondary Outcome Measures

Name	Time	Method
IMR 6 months after SAVR/TAVI.	6 months	Measurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR.
FFR versus RFR to determine ischemia.	Baseline	Comparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia.

Trial Locations

Locations (3)

UZ Leuven; 🇧🇪 Leuven, Vlaams-brabant, Belgium

University hospital Antwerp; 🇧🇪 Antwerpen, Belgium

AZ Delta; 🇧🇪 Roeselare, Belgium