Translational-Omics in Aortic Stenosis (TOmAS) Biobank

NCT05930899 | Recruiting DMC

• 1 other identifier: A02-M104-13A
• Study Type: observational
• Target: 10,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Cardiovascular Diseases; Aortic Valve Stenosis

Outcome Measures

Primary Outcomes (1)

• TOmAS

  Identifying genetic differences between cases and controls.

  5 years

Study Arms (2)

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

Control Group

control groups will be defined as: 1. No echocardiographic evidence of AS (or any aortic valve abnormality) and 2. 60 years of age

Other: Genetics

Interventions

Genetics OTHER

TOmAS is a biobank and all patients will be genotyped

CVD Group; Control Group

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• Individuals with Congenital heart disease will be excluded

Sponsors & Collaborators

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

Study Sites (2)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

RECRUITING

Royal Victoria Hospital

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

biological material including plasma, saliva, genetic material (DNA, RNA, etc.), and tissue explanted during surgery

MeSH Terms

Conditions

Cardiovascular Diseases; Aortic Valve Stenosis

Condition Hierarchy (Ancestors)

Aortic Valve Disease; Heart Valve Diseases; Heart Diseases; Ventricular Outflow Obstruction

Central Study Contacts

George Thanassoulis, MD

CONTACT

5149341934; george.thanassoulis@mcgill.ca

Mireille Roy-Joncas, RN

CONTACT

5149341934; mireille.roy-joncas@muhc.mcgill.ca

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine, Director, Preventive and Genomic Cardiology

Study Record Dates

• First Submitted: June 22, 2023
• First Posted: July 5, 2023
• Study Start: October 12, 2017
• Primary Completion (Estimated): January 1, 2040
• Study Completion (Estimated): January 1, 2040
• Last Updated: November 20, 2024

Record last verified: 2024-11

Locations

CA (2)