Translational-Omics in Aortic Stenosis (TOmAS) Biobank

Sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre (Other)
Overall Status
Recruiting
CT.gov ID
NCT05930899
Collaborator
(none)
10,000
2
266.6
5000
18.8

Study Details

Study Description

Brief Summary

The objective of the TOmAS Biobank is the conservation of biological material (plasma, saliva, and tissue explanted during surgery), genetic material (DNA, RNA, etc.), and clinical data ("material/data") collected from patients with cardiovascular diseases (CVD) as well as from control participants, in order to allow future studies evaluating novel proteomic, transcriptomic and epigenomic markers (as well as other emerging -omic technologies) for CVD (i.e. aortic stenosis, cardiomyopathy, myorcardial infarction, etc). The study of physiological and genetic factors will allow for the discovery of new genomic and other -omic (including proteomic, transcriptomic and epigenomic) biomarkers associated with CVD which will lead to an improved understanding of the underlying biology of CVD and may provide future insights into the prevention and treatment of this type of disease.

Condition or Disease Intervention/Treatment Phase
  • Other: Genetics

Detailed Description

Inherited from parents, DNA is organized into genes and is unique to each individual. Genes contain the information that dictates how cells function and hence, can also influence the risk of developing diseases. Due to the uniqueness and variability between each individual, genes can confer different risks of developing diseases when comparing one person to another person (or a group of people). When a biological product can be measured to predict whether someone is at a higher risk for a certain disease, it is called a "biomarker". Biomarkers include, but are not limited to genetic material (such as DNA) and certain proteins found in the heart and the blood. By studying genes and proteins isolated from biological samples (blood, saliva and heart tissue), investigators of this Biobank hope to characterize known biomarkers, identify novel biomarkers and ultimately, improve the diagnosis and treatment of heart diseases.

The purpose of this research is to: (1) perform a genetic study of cardiovascular diseases, such as aortic valve diseases and (2) create a biobank (that will include blood samples, genetic material, and tissue explanted at surgery) to be used for analysis in the future.

Study Design

Study Type:
Observational
Anticipated Enrollment :
10000 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Translational-Omics in Aortic Stenosis (TOmAS) Biobank
Actual Study Start Date :
Oct 12, 2017
Anticipated Primary Completion Date :
Jan 1, 2040
Anticipated Study Completion Date :
Jan 1, 2040

Arms and Interventions

Arm Intervention/Treatment
CVD Group

CVD diagnosis including, but not limited to: Aortic Stenosis, Coronary Heart Disease, Heart Failure, Atrial Fibrilation, Dilated Cardiomyopathy, Myocardial Infarction, and Spontaneous Coronary Artery Dissection.

Other: Genetics
TOmAS is a biobank and all patients will be genotyped

Control Group

control groups will be defined as: No echocardiographic evidence of AS (or any aortic valve abnormality) and 60 years of age

Other: Genetics
TOmAS is a biobank and all patients will be genotyped

Outcome Measures

Primary Outcome Measures

  1. TOmAS [5 years]

    Identifying genetic differences between cases and controls.

Eligibility Criteria

Criteria

Ages Eligible for Study:
19 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • CVD diagnosis including, but not limited to: Aortic Stenosis, Coronary Heart Disease, Heart Failure, Atrial Fibrilation, Dilated Cardiomyopathy, Myocardial Infarction, and Spontaneous Coronary Artery Dissection.

  • Undergoing cardiac surgery for non-aortic valve pathology

Exclusion Criteria:
  • Individuals with Congenital heart disease will be excluded

Contacts and Locations

Locations

Site City State Country Postal Code
1 Montreal General Hospital Montréal Quebec Canada H3G 1A4
2 Royal Victoria Hospital Montréal Quebec Canada H4A 3J1

Sponsors and Collaborators

  • McGill University Health Centre/Research Institute of the McGill University Health Centre

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
George Thanassoulis, Professor of Medicine, Director, Preventive and Genomic Cardiology, McGill University Health Centre/Research Institute of the McGill University Health Centre
ClinicalTrials.gov Identifier:
NCT05930899
Other Study ID Numbers:
  • A02-M104-13A
First Posted:
Jul 5, 2023
Last Update Posted:
Jul 5, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
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 Jul 5, 2023