COronary and MICrocirculatory Measurements in Patients With Aortic Valve Stenosis.

  • STATUS
    Recruiting
  • End date
    Dec 31, 2023
  • participants needed
    80
  • sponsor
    Universitaire Ziekenhuizen Leuven
Updated on 25 January 2021
ct scan
stenosis
coronary artery disease
ischemia
coronary artery stenosis
SPECT Scan
aortic valve stenosis
transcatheter aortic valve implantation
tavi
arterial disease
hypertrophy
revascularisation

Summary

Aortic stenosis (AS) is the most common primary valve disease leading to surgery or catheter intervention in Europe, with a growing prevalence due to the aging population. Severe AS is associated with significant morbidity and mortality and is treated by surgical valve replacement (SAVR) or transcatheter aortic valve implantation (TAVI). However, significant coronary artery disease (CAD) is reported in more than 60% of patients with AS, and this concomitant CAD needs to be correctly assessed because untreated significant CAD is associated with adverse outcomes. Current guidelines recommend intra-coronary pressure measurement using either fractional flow reserve (FFR) or non-hyperemic pressure ratios (NHPR) for the assessment of intermediate coronary artery lesions before revascularization. However, correctly identifying hemodynamically significant coronary stenoses by FFR or NHPR is difficult in patients with AS because of the hypertrophic remodeling related to the valve pathology, which interferes with coronary blood flow in the microcirculation and reduces the accuracy of FFR and NHPR. This has resulted in substantial controversy in this field of coronary artery disease and there is currently no clear guideline for the management of AS patients with concomitant CAD. Recent technological advances now permit the concomitant evaluation of FFR/NHPR and microcirculatory function at the time of cardiac catheterization. Using this technology, we will simultaneously evaluate the hemodynamic significance of coronary stenoses (using FFR and a NHPR - Resting Full cycle Ratio [RFR]) and the microcirculatory function (Index of Microcirculatory Resistance, IMR) in patients with AS and CAD prior to SAVR/TAVI. Eighty patients with AS and intermediate CAD will be included in the study. During routine pre-valve replacement cardiac catheterization, measurement of intermediate CAD lesions (by FFR and RFR) and IMR will be performed using new software. These measures of CAD severity will be compared with a gold standard non-invasive test (single photon emission computed tomography [SPECT]). This will validate the use of RFR and determine if IMR can be used to improve the ischemia prediction of FFR. Subsequently, when these patients undergo a post-intervention (whether SAVR or TAVI) evaluation 6 months after valve replacement, the effect of valve replacement on FFR, RFR and IMR will be determined.

Details
Condition Coronary Artery Disease, Coronary Artery Disease, Aortic Stenosis, Coronary heart disease, VALVULAR HEART DISEASE, Heart Valve Disease, Cardiac Ischemia, Heart Valve Disease, Myocardial Ischemia, aortic valve stenosis
Clinical Study IdentifierNCT04420325
SponsorUniversitaire Ziekenhuizen Leuven
Last Modified on25 January 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

\. 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

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
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