iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

NCT ID: NCT06371937

Last Updated: 2024-05-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-01
• Study Completion Date: 2033-06-30

Brief Summary

The Investigators will create a clinical database and a Biobank of stem cells derived from the blood of participants with cardiovascular disease. The Investigators will recruit participants from diverse racial and ethnic backgrounds with equal representation from both sexes. The Investigators expect to create stem cells and analyze the blood for protein biomarkers and genetic causes of cardiovascular disease. The stem cell biobank and clinical data will be a powerful tool for studying cardiovascular disease.

Detailed Description

Cardiovascular disease is the leading cause of morbidity and mortality. The development of cardiovascular disease includes both genetic and epigenetic factors. Understanding their molecular and cellular mechanism is necessary to identify novel drug targets and treat the disease. Present in vitro and in vivo models of the disease do not mimic human pathophysiology, and obtaining the primary cells from the patients for the studies relevant to the cardiovascular and pulmonary system is difficult. Induced pluripotent stem cells (iPSCs) are derived from a person's blood cells and facilitate the discovery of cardiovascular disease mechanisms. The Investigators propose recruiting cardiovascular patients from diverse ethnic backgrounds and creating a rich clinical database using REDCap. Blood samples will be obtained from participants and used to create iPSCs. The participant will have DNA sequencing, and serum will be analyzed for protein biomarkers. The multi-omics data and reprogrammed iPSCs will be stored in the Cardiology and Critical Care (C3RP) laboratory at the Robarts Research Institute at Western University. The reprogrammed iPSCs can generate a limitless supply of cardiovascular tissue. Moreover, the iPSC-derived data will be correlated with clinical information, genetic sequencing, and protein biomarkers from serum analysis. The Investigators expect to create an iPSC biobank coupled with a rich clinical dataset, including genetic sequencing analysis and protein biomarkers that will enable the discovery of novel biomarkers and drug targets for cardiovascular disease.

Conditions

Cardiovascular Diseases; Arrythmia; Cardiomyopathies; Heart Failure; Cerebrovascular Accident; Congenital Heart Disease; Cardiometabolic Syndrome

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: PROSPECTIVE

Study Groups

study controls

Healthy control participants (n=50) aged 80 and older enrolled in the study with no known CVD or history of significant medical problems.

No interventions assigned to this group

cardiovascular disease

Participants with cardiovascular disease (n=150)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Adult (18 to 80 years of age)
• Cardiovascular Disease (CVD)
• Cerebrovascular Disease (CBD)
• Peripheral Vascular Disease (PVD)
• Inherited Arrhythmias
• Cardiomyopathies
• Congenital Heart Disease (CHD)
• Aortopathy
• Hypertension
• Cardiometabolic Disease (CMD)

Exclusion Criteria

• Younger than 18 years of age.
• Patients not able to provide consent.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Greenstone Biosciences, Inc.

INDUSTRY

Sponsor Role: collaborator

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

OTHER

Sponsor Role: lead

Responsible Party

Mark Chandy

Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

London Regional Health Science Centre

London, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Facility Contacts

Mark Chandy, MD PhD

Role: primary

mark.chandy@lhsc.on.ca

5196612111

Other Identifiers

120687

Identifier Type: -

Identifier Source: org_study_id