Clinical trial NCT06371937: iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease
Official title: Blood Biomarkers From Ethnically Diverse Cardiovascular Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiovascular Diseases
Arrythmia
Cardiomyopathies
Heart Failure
Cerebrovascular Accident
Congenital Heart Disease
Cardiometabolic Syndrome
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: Greenstone Biosciences, Inc.
First posted: 2024-04-17
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: We will recruit 200 participants including 150 patients with cardiovascular disease and 50 healthy control participants.

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.

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.

Primary outcomes:
measure: REDCap Database
timeFrame: 10 years
measure: Induced pluripotent stem cell (iPSC) Biobank
timeFrame: 10 years
measure: Differentiation into Cardiovascular lineages
timeFrame: 10 years
measure: Molecular profiling of participants
timeFrame: 10 years
measure: Bioinformatics analysis
timeFrame: 10 years
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Regional Health Science Centre
state: Ontario
Study officials:
References: