COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

NCT04420325 | Completed Results

• 1 other identifier: S63740
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 3

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.

Conditions

Aortic Stenosis; Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (2)

• IMR 6 Months After SAVR/TAVI.

  6 months

• FFR Versus RFR to Determine Ischemia.

  Baseline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• \. 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.
• \. The patient has an intermediate (50-90%) coronary lesion that requires further evaluation.
• \. The patient undergoing the procedure is male, or if female, has no childbearing potential or is not pregnant.

You may not qualify if:

• 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
• 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.

Sponsors & Collaborators

• Universitaire Ziekenhuizen KU Leuven: lead
• AZ Delta: collaborator
• University Hospital, Antwerp: collaborator

Study Sites (3)

UZ Leuven

Leuven, Vlaams-brabant, 3000, Belgium

Location

University hospital Antwerp

Antwerp, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Related Links

• Rationale and Design paper

Biospecimen

Retention: SAMPLES WITH DNA

Before IMR measurement, a peripheral blood sample (10cc EDTA, citrate and 2.5mL PaxGene® RNA tube) will be obtained to assess platelet function and for biomarker evaluation (RNA analysis).

MeSH Terms

Conditions

Aortic Valve Stenosis; Coronary Artery Disease

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases; Ventricular Outflow Obstruction; Coronary Disease; Myocardial Ischemia; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

First, microvascular function analysis was based on bolus-thermodilution,recent studies have shown that continuous coronary thermodilution may have better reproducibility. Second, myocardial perfusion SPECT is not the gold standard for non-invasive detection of ischemia.

Results Point of Contact

• Title: Lennert Minten
• Organization: UZ Leuven

lennert.minten@gmail.com

+32496397568

Study Officials

• Christophe Dubois, MD, PhD

  UZ Leuven

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 3, 2020
• First Posted: June 9, 2020
• Study Start: June 1, 2020
• Primary Completion: April 1, 2024
• Study Completion: October 1, 2024
• Last Updated: September 5, 2025
• Results First Posted: September 5, 2025

Record last verified: 2025-06

Locations

BE (3)