Translational-Omics in Aortic Stenosis (TOmAS) Biobank

Cardiovascular Diseases Clinical Trial

Official title:

Translational-Omics in Aortic Stenosis (TOmAS) Biobank

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05930899
• Other study ID #: A02-M104-13A
• Status: Recruiting
• Start date: October 12, 2017
• Est. completion date: January 1, 2040

Study information

• Verified date: June 2023
• Source: McGill University Health Centre/Research Institute of the McGill University Health Centre
• Contact: George Thanassoulis, MD
• Phone: 5149341934
• Email: george.thanassoulis[@]mcgill.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: January 1, 2040
• Est. primary completion date: January 1, 2040
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 19 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Aortic Valve Stenosis
• Cardiovascular Diseases
• Constriction, Pathologic

Intervention

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

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montréal	Quebec
Canada	Royal Victoria Hospital	Montréal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Centre/Research Institute of the McGill University Health Centre

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	TOmAS	Identifying genetic differences between cases and controls.	5 years