COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis. (COMIC-AS)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Coronary Artery Disease; Aortic Stenosis

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 Type: Observational
• Enrollment (Actual): 116

Contacts and Locations

• Study Contact: Name: Karin R Broos; Phone Number: +32468312267 +3216342465; Email: karin.broos@uzleuven.be
• Study Contact Backup: Name: Lennert Minten, MD; Phone Number: +32 16 34 59 14; Email: Lennert.minten@gmail.com

Study Locations

• Belgium
  • Antwerpen, Belgium
    • University Hospital Antwerp
  • Roeselare, Belgium
    • AZ DELTA
  • Vlaams-brabant
    • Leuven, Vlaams-brabant, Belgium, 3000
      • UZ Leuven

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	6 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Universitaire Ziekenhuizen KU Leuven
• Collaborators: University Hospital, Antwerp; AZ Delta
• Investigators: Principal Investigator: Christophe Dubois, MD, PhD, UZ Leuven

Publications and helpful links

Helpful Links

• Rationale and Design paper

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2020
• Primary Completion (Actual): April 1, 2024
• Study Completion (Estimated): July 1, 2024

Study Registration Dates

• First Submitted: June 3, 2020
• First Submitted That Met QC Criteria: June 3, 2020
• First Posted (Actual): June 9, 2020

Study Record Updates

• Last Update Posted (Actual): April 9, 2024
• Last Update Submitted That Met QC Criteria: April 4, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Coronary Disease; Coronary Artery Disease; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: S63740

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No