NCT04420325

COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

COronary and MICrocirculatory Measurements in Patients With Aortic Valve, the COMIC AS Study.

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 116 (actual)
• Sponsor: Universitaire Ziekenhuizen KU Leuven · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Conditions

• Aortic Stenosis
• Coronary Artery Disease

Timeline

• Start date: 2020-06-01
• Primary completion: 2024-04-01
• Completion: 2024-10-01
• First posted: 2020-06-09
• Last updated: 2025-09-05
• Results posted: 2025-09-05

Locations

3 sites across 1 country: Belgium