Aortic StenosisCOMIC-ASNCT04420325
COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.
An observational study of Aortic Stenosis and Coronary Artery Disease, run by Universitaire Ziekenhuizen KU Leuven at 3 sites in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Stenosis, Coronary Artery Disease
- How many people
- 116 participants
- Where
- 3 sitesBelgium
- Study dates
- 1 Jun 2020to 1 Oct 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing routine cardiac catheterization during preparation for TAVI or SAVR, who are found to have coronary artery disease, will be approached to take part.
Who may be able to join
- 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.
Who cannot join
- 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
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- 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.
Trial locations and contacts
3 sites in 1 country.
Belgium3 sites
University hospital Antwerp
Antwerp
UZ Leuven
Leuven, Vlaams-brabant, 3000
AZ Delta
Roeselare
About this study
Official title: COronary and MICrocirculatory Measurements in Patients With Aortic Valve, the COMIC AS Study.
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.
Read the 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
- Medical subject headings
- Aortic Valve Stenosis, Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
FFR 6 Months After SAVR/TAVI.
Aortic valve intervention can potentially result in a change in fractional flow reserve (FFR) 6 months after SAVR/TAVI.
FFR is the ratio of two intra-coronary measurements (Distal coronary pressure divided by proximal coronary pressure) and can range from 0.0-1.0.
A lower FFR means that the lesion is more severe and therefore a higher FFR is considered better. The threshold to speak about hemodynamic significant of a lesion is 0.80. If the lesion has an FFR of ≤ 0.80 means the lesions is significant and treatment is necessary.
Measured: 6 months
Secondary outcomes (2)
IMR 6 Months After SAVR/TAVI.
Measurement of IMR in patients with AS prior to intervention and 6 months after TAVI/SAVR.
IMR is unitless and gives a description of coronary microvascular resistance, it can range from 0-100.
Lower values are considered better as they are related with better microvascular function and health.
If the IMR > 25 we say microvascular dysfunction is present and treatment is considered necessary.
Measured: 6 months
FFR Versus RFR to Determine Ischemia.
Comparison of the diagnostic performance of FFR versus RFR compared with SPECT ischemia.
The higher the Area under the curve the better. The range is 0.0-1.0. An area under the curve for a ROC model is considered excellent if > 0.8.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2020
- Study start1 Jun 2020
- Primary completion1 Apr 2024
- Study completion1 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Aortic StenosisStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 116 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Collaborators
- AZ Delta, University Hospital, Antwerp
- Responsible party
- Sponsor
- Investigators
- Christophe Dubois, MD, PhD, Principal investigator, UZ Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04420325
- Sponsor's protocol ID
- S63740
- Acronym
- COMIC-AS
- Status last verified
- Jun 2025
- First submitted
- 3 Jun 2020
- Last updated
- 5 Sep 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided