Identification of Genetic Causes of Calcific Aortic Valve Disease

Sponsor
Beth Israel Deaconess Medical Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT04149600
Collaborator
Brigham and Women's Hospital (Other)
1,000
Enrollment
1
Location
105.1
Anticipated Duration (Months)
9.5
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This study aims to identify the molecular genetic causes of the variability in development of calcific aortic valve disease in bicuspid and tricuspid aortic valves and their associated aortic dilation.

Condition or DiseaseIntervention/TreatmentPhase
  • Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.

Study Design

Study Type:
Observational
Anticipated Enrollment :
1000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Identification of Genetic Causes of Calcific Aortic Valve Disease
Actual Study Start Date :
Sep 25, 2018
Anticipated Primary Completion Date :
Jun 30, 2027
Anticipated Study Completion Date :
Jun 30, 2027

Arms and Interventions

ArmIntervention/Treatment
Bicuspid aortic valve

We wish to investigate the etiology of calcific aortic valve disease, and aortic dilation or aneurysm in patients with a bicuspid aortic valve undergoing aortic valve replacement or aortic surgery.

Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

Tricuspid aortic valve

Data and samples will be compared using a control group comprised of patients with a tricuspid aortic valve undergoing aortic surgery.

Procedure: Patients scheduled to undergo aortic valve replacement or aortic surgery at BIDMC will be approached for participation in this study.
Adult patients undergoing aortic valve replacement (AVR) and/or aortic resection will be enrolled.

Outcome Measures

Primary Outcome Measures

  1. Identification of expression signatures of aortic valve development and calcification in the macroscopically normal and abnormal portions of aortic valves excised during aortic valve replacement. [8 years]

    We will take a portion of the aortic valve and/or aortic tissue that is routinely excised for aortic valve or aortic replacement for expression analyses and generation of fibroblast cell lines. In collaboration with the Department of Pathology, we have established methods to take sufficient "normal" and abnormal tissue while allowing formal routine pathological evaluation. All tissue samples for expression analysis will be transported in iced RNALater and later frozen in a -80°C research freezer, prior to next generation sequencing. We may use tissue samples to develop cell lines for indefinite use.

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • Patients with a plan to undergo elective aortic valve replacement and/or ascending aortic surgery
Exclusion Criteria:
  • Age < 20 years

  • Unable/unwilling to consent

  • History of aortic valve replacement or transcatheter aortic valve replacement (TAVR)

  • History of endocarditis

  • History of rheumatic fever

  • History of chest radiotherapy

  • History of organ transplant

Contacts and Locations

Locations

SiteCityStateCountryPostal Code
1Beth Israel Deaconess Medical CenterBostonMassachusettsUnited States02215

Sponsors and Collaborators

  • Beth Israel Deaconess Medical Center
  • Brigham and Women's Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Simon Robson, Professor of Anaesthesia, Beth Israel Deaconess Medical Center
ClinicalTrials.gov Identifier:
NCT04149600
Other Study ID Numbers:
  • 2018P000380
First Posted:
Nov 4, 2019
Last Update Posted:
Apr 29, 2021
Last Verified:
Apr 1, 2021
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:

Study Results

No Results Posted as of Apr 29, 2021