Translational-Omics in Aortic Stenosis (TOmAS) Biobank

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.

Study Overview

• Status: Recruiting
• Conditions: Cardiovascular Diseases; Aortic Valve Stenosis
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Estimated): 10000

Contacts and Locations

• Study Contact: Name: George Thanassoulis, MD; Phone Number: 5149341934; Email: george.thanassoulis@mcgill.ca
• Study Contact Backup: Name: Mireille Roy-Joncas, RN; Phone Number: 76219 5149341934; Email: mireille.roy-joncas@muhc.mcgill.ca

Study Locations

• Canada
  • Quebec
    • Montréal, Quebec, Canada, H3G 1A4
      • Recruiting
      • Montreal General Hospital
      • Contact: George Thanassoulis, MD; Phone Number: 5142340818; Email: george.thanassoulis@mcgill.ca
    • Montréal, Quebec, Canada, H4A 3J1
      • Recruiting
      • Royal Victoria Hospital
      • Contact: George Thanassoulis, MD; Phone Number: 5149341934; Email: george.thanassoulis@mcgill.ca

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Individuals over 18 who meet the inclusion criteria for either the case or the control group.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
TOmAS	Identifying genetic differences between cases and controls.	5 years

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 12, 2017
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040

Study Registration Dates

• First Submitted: June 22, 2023
• First Submitted That Met QC Criteria: June 29, 2023
• First Posted (Actual): July 5, 2023

Study Record Updates

• Last Update Posted (Actual): July 5, 2023
• Last Update Submitted That Met QC Criteria: June 29, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Pathological Conditions, Anatomical; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Cardiovascular Diseases; Aortic Valve Stenosis; Constriction, Pathologic
• Other Study ID Numbers: A02-M104-13A

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No