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

Sponsor
Matteo Montorfano (Other)
Overall Status
Recruiting
CT.gov ID
NCT05326126
Collaborator
(none)
75
Enrollment
1
Location
1
Arm
15.7
Anticipated Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Device: coronary physiology
 N/A

Detailed 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Intervention Model Description:
TAVI's intervention will be performed as per current clinical indications and according to the hospital's clinical practice. To this will be added the evaluation of coronary physiology using Pressure Eire X and Coroventis software, which, although performed in accordance with the IFU of the aforementioned devices, is considered an experimental procedure. Adenosine will be required to complete the measurement of coronary physiologyTAVI's intervention will be performed as per current clinical indications and according to the hospital's clinical practice. To this will be added the evaluation of coronary physiology using Pressure Eire X and Coroventis software, which, although performed in accordance with the IFU of the aforementioned devices, is considered an experimental procedure. Adenosine will be required to complete the measurement of coronary physiology
Masking:
None (Open Label)
Masking Description:
Patients will be assigned a univocal identification code. Medical personnel in charge of baseline, in-hospital and follow-up data acquisition will be allowed to know each patient identity.
Primary Purpose:
Other
Official Title:
Microvascular Function in Patients Undergoing Transcatheter Aortic Valve Implant (TAVI) for Severe Symptomatic Aortic Stenosis: Association With Myocardial Fibrosis
Actual Study Start Date :
Jul 8, 2021
Anticipated Primary Completion Date :
Sep 30, 2022
Anticipated Study Completion Date :
Oct 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Coronary physiology evaluation

Patient will undergo TAVI and then Myocardial fibrosis will be evaluated on images acquired at the time of the cardiac CT obtained for TAVI planning. Briefly, an extra late post-contrast acquisition image will be acquired. The delayed post-contrast scan will be reconstructed with a soft convolution kernel and will be reformatted in the short- and long-axis planes (slice thickness 8 mm; gap 0 mm) in average mode.

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.

Outcome Measures

Primary Outcome Measures

  1. The burden of myocardial fibrosis [1 year]

    Myocardial fibrosis measured as the percentage of delay-enhanced myocardium over total myocardial volume

  2. Index of microcirculatory resistance (IMR) [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.

Secondary Outcome Measures

  1. Acute change in coronary flow reserve (CRF) [1 year]

    Ratio of maximal coronary blood flow obtained by hyperemia to baseline coronary blood flow

  2. Acute change in index of microcirculatory resistance (IMR) [1 year]

    Estimate of microvascular resistance derived by pressure and an indirect estimate of flow

  3. Computed tomography derived extracellular volume [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)

  4. All-cause death [1 year]

    Death from any cause

  5. Cardiovascular death [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…)

  6. Any rehospitalization [1 year]

    Admission to an inpatients' service for any cause lasting >24h

  7. Cardiovascular rehospitalization [1 year]

    Admission to an inpatients' service for cardiovascular conditions lasting >24h

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 80 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 IRCCS San Raffaele Milan Italy 20132

Sponsors and Collaborators

  • Matteo Montorfano

Investigators

  • Principal Investigator: Matteo montorfano, MD, IRCCS San Raffaele

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Matteo Montorfano, Interventional cardiologist, IRCCS San Raffaele
ClinicalTrials.gov Identifier:
NCT05326126
Other Study ID Numbers:
  • TAVI IMR
First Posted:
Apr 13, 2022
Last Update Posted:
Aug 3, 2022
Last Verified:
Aug 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Aortic Valve Stenosis
Constriction, Pathologic

Study Results

No Results Posted as of Aug 3, 2022