Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis

Severe Symptomatic Aortic Stenosis Clinical Trial

Official title:

Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05326126
• Other study ID #: TAVI IMR
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: October 30, 2025

Study information

• Verified date: March 2024
• Source: IRCCS San Raffaele
• Contact: Marco Ancona, MD
• Phone: +39/26437331
• Email: ancona.marco[@]hsr.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Microvascular function in patients undergoing Transcatheter Aortic Valve Implant (TAVI) for severe symptomatic aortic stenosis: association with myocardial fibrosis

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: October 30, 2025
• Est. primary completion date: October 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• All patients referred to IRCCS Ospedale San Raffaele who are candidates to receive a TAVI implant for severe, symptomatic aortic stenosis under current appropriateness criteria and clinical practice guidelines will be considered eligible to take part in the study

Exclusion Criteria:

• Age <18 years

• Inability to express informed consent to take part in the present study.

• Pregnancy or lactation

• Pre-existing known disease determining a prognosis quo ad vitam shorter than the follow up of the present study

• Significant chronic kidney disease (estimated glomerular filtration rate <30 ml/min)

• Known significant epicardial coronary artery stenosis

• Known contraindication to adenosine administration:

• Known allergic reactions

• Second or third degree atrioventricular block before the procedure (in absence of a functional permanent pacemaker)

• Long QT syndrome

• Unstable angina

• Severe hypotension

• Acutely decompensated heart failure

• Chronic obstructive pulmonary disease with bronchospasm

• Concomitant use of dypiridamole

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Constriction, Pathologic
• Severe Symptomatic Aortic Stenosis

Intervention

Device:
• coronary physiology
To evaluate the association between microvascular disfunction and myocardial fibrosis identified per computed tomography among subjects undergoing TAVI for severe, symptomatic aortic stenosis.

Locations

Country	Name	City	State
Italy	IRCCS San Raffaele	Milan

Sponsors (1)

Lead Sponsor	Collaborator
Matteo Montorfano

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The burden of myocardial fibrosis	Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume	1 year
Primary	Index of microcirculatory resistance (IMR)	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.	1 year
Secondary	Acute change in coronary flow reserve (CRF)	Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow	1 year
Secondary	Acute change in index of microcirculatory resistance (IMR)	Estimate of microvascular resistance derived by pressure and an indirect estimate of flow	1 year
Secondary	Computed tomography derived extracellular volume	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) × (?HUmyo/?HUblood) where ?HU is the change in Hounsfield unit attenuation pre- and post-contrast (i.e. HUpost-contrast - HUpre-contrast)	1 year
Secondary	All-cause death	Death from any cause	1 year
Secondary	Cardiovascular death	Death from any cardiac condition (e.g. myocardial infarction, acute pulmonary edema, low-output state, etc..) or vascular condition (including aortic dissection, stroke, etc…)	1 year
Secondary	Any rehospitalization	Admission to an inpatients' service for any cause lasting >24h	1 year
Secondary	Cardiovascular rehospitalization	Admission to an inpatients' service for cardiovascular conditions lasting >24h	1 year