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Translational-Omics in Aortic Stenosis (TOmAS) Biobank

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ClinicalTrials.gov Identifier: NCT05930899
Recruitment Status : Recruiting
First Posted : July 5, 2023
Last Update Posted : July 5, 2023
Sponsor:
Information provided by (Responsible Party):
George Thanassoulis, McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Description
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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
Cardiovascular Diseases Aortic Valve Stenosis 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
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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Translational-Omics in Aortic Stenosis (TOmAS) Biobank
Actual Study Start Date : October 12, 2017
Estimated Primary Completion Date : January 1, 2040
Estimated Study Completion Date : January 1, 2040

Resource links provided by the National Library of Medicine


Groups and Cohorts
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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:

  1. No echocardiographic evidence of AS (or any aortic valve abnormality) and
  2. 60 years of age
 Other: Genetics
TOmAS is a biobank and all patients will be genotyped


Outcome Measures
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Primary Outcome Measures :
  1. TOmAS [ Time Frame: 5 years ]
    Identifying genetic differences between cases and controls.


Biospecimen Retention:   Samples With DNA
biological material including plasma, saliva, genetic material (DNA, RNA, etc.), and tissue explanted during surgery

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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.
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05930899


Contacts
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Contact: George Thanassoulis, MD 5149341934 george.thanassoulis@mcgill.ca
Contact: Mireille Roy-Joncas, RN 5149341934 ext 76219 mireille.roy-joncas@muhc.mcgill.ca

Locations
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Canada, Quebec
Montreal General Hospital Recruiting
Montréal, Quebec, Canada, H3G 1A4
Contact: George Thanassoulis, MD    5142340818    george.thanassoulis@mcgill.ca   
Royal Victoria Hospital Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: George Thanassoulis, MD    5149341934    george.thanassoulis@mcgill.ca   
Sponsors and Collaborators
McGill University Health Centre/Research Institute of the McGill University Health Centre
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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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: July 5, 2023    Key Record Dates
Last Update Posted: July 5, 2023
Last Verified: June 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Cardiovascular Diseases
Aortic Valve Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
 Aortic Valve Disease
Heart Valve Diseases
Heart Diseases
Ventricular Outflow Obstruction