NCT04420325Completed
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
COronary and MICrocirculatory Measurements in Patients With Aortic Valve, the COMIC AS Study.
Source: ClinicalTrials.gov · Last updated 5 Sept 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 116 (actual)
- First submitted
- 3 Jun 2020
- Start date
- 1 Jun 2020
- Primary completion date
- 1 Apr 2024
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Diseases
- Coronary artery disease
- NCT number
- NCT04420325
What you commit to
- Study type: Observational
- Participants enrolled: 116
- From 1 Jun 2020 to the primary completion date, 1 Apr 2024
- 3 sites 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.
Prior treatment
- Previous coronary artery by-pass in the artery being assessed
- 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.
Other illness
- Killip class III-IV heart failure
- No significant coronary artery disease (\<50% stenosis on angiography).
- Critical coronary artery disease deemed by the Heart Team to require immediate revascularization
Other
- The procedure is an emergency and/or the patient is unstable.
- Pregnancy or lactation
- Haemodynamically unstable patients
- Contra-indications for adenosine administration: severe asthma or pre-existing type 2 AV-block
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Hospital, Antwerp Coordinator of this site? Confirm its status | Antwerp | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| AZ Delta Coordinator of this site? Confirm its status | Roeselare | Belgium | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.