iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

Heart Failure Clinical Trial

— INFERENCE  

Official title:

Blood Biomarkers From Ethnically Diverse Cardiovascular Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06371937
• Other study ID #: 120687
• Status: Recruiting
• Start date: May 1, 2024
• Est. completion date: June 30, 2033

Study information

• Verified date: May 2024
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 30, 2033
• Est. primary completion date: June 30, 2033
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arrythmia
• Cardiometabolic Syndrome
• Cardiomyopathies
• Cardiovascular Diseases
• Cerebrovascular Accident
• Congenital Heart Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure
• Metabolic Syndrome
• Stroke

Locations

Country	Name	City	State
Canada	London Regional Health Science Centre	London	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Lawson Health Research Institute	Greenstone Biosciences, Inc.

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	REDCap Database	Identify patients with cardiovascular disease from ethnically diverse backgrounds and create a clinical database with REDCap.	10 years
Primary	Induced pluripotent stem cell (iPSC) Biobank	Reprogram peripheral blood mononuclear cells (PBMC) to iPSCs.	10 years
Primary	Differentiation into Cardiovascular lineages	Differentiate of iPSCs into different cardiovascular lineages (endothelial cells, smooth muscle cells, cardiomyocytes, etc.)	10 years
Primary	Molecular profiling of participants	Molecular profiling of iPSC-derived tissue and patient serum using microarray, DNA sequencing, and high throughput "omics" technologies (transcriptomic analysis, proteomic analysis, metabolomic studies, and functional assays).	10 years
Primary	Bioinformatics analysis	Bioinformatics analysis of clinical, iPSC disease modeling, and serum omics analysis.	10 years