IRCCS San Raffaele
Milan, 20132, Italy
NCT Number: NCT05326126
Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis
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Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Milan, 20132, Italy
Severe symptomatic aortic stenosis is commonly encountered in clinical practice, affecting close to 5% of individuals older than 65 years of age, and carries a dismal prognosis if left untreated.(1,2) Chronically increased left ventricular afterload triggers a compensatory myocardial response, ultimately leading to ventricular hypertrophy, aimed at reducing chronically increased wall tension an restore cardiac performance.(3) Hypertrophy ultimately results in maladaptive changes and ultimately leads to heart failure and eventually increased risk of cardiac mortality. Myocardial fibrosis and altered myocardial perfusion appear to play a role in progressive cardiac decompensation.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
To evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis.
Time frame: 1 year
Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume
Time frame: 1 year
IMR a validated estimate of resistance in the coronary capillary, computed as the ratio between transit time of a 3 cc bolus of room temperature saline and distal coronary artery pressure.
Time frame: 1 year
Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow
Time frame: 1 year
Estimate of microvascular resistance derived by pressure and an indirect estimate of flow
Time frame: 1 year
The extracellular volume fraction (ECV) is the relative value of the volume of the extracellular space in the myocardium, therefore express as a percentage. It could be measured from computed tomography (CT) and Index of microcirculatory resistance (MRI) images, and was validated with histology. ECV-CT is calculated as follows:
ECVCT = (1-haematocrit) × (ΔHUmyo/ΔHUblood) where ΔHU is the change in Hounsfield unit attenuation pre- and post-contrast (i.e. HUpost-contrast - HUpre-contrast)
Time frame: 1 year
Death from any cause
Time frame: 1 year
Death from any cardiac condition (e.g. myocardial infarction, acute pulmonary edema, low-output state, etc..) or vascular condition (including aortic dissection, stroke, etc…)
Time frame: 1 year
Admission to an inpatients' service for any cause lasting >24h
Time frame: 1 year
Admission to an inpatients' service for cardiovascular conditions lasting >24h
Matteo Montorfano
Other
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