iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

NCT06371937 | Recruiting

• 1 other identifier: 120687
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (5)

• REDCap Database

  Identify patients with cardiovascular disease from ethnically diverse backgrounds and create a clinical database with REDCap.

  10 years

• Induced pluripotent stem cell (iPSC) Biobank

  Reprogram peripheral blood mononuclear cells (PBMC) to iPSCs.

  10 years

• Differentiation into Cardiovascular lineages

  Differentiate of iPSCs into different cardiovascular lineages (endothelial cells, smooth muscle cells, cardiomyocytes, etc.)

  10 years

• 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

• Bioinformatics analysis

  Bioinformatics analysis of clinical, iPSC disease modeling, and serum omics analysis.

  10 years

Study Arms (2)

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.

cardiovascular disease

Participants with cardiovascular disease (n=150)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

We will recruit 200 participants including 150 patients with cardiovascular disease and 50 healthy control participants.

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Greenstone Biosciences, Inc.: collaborator

Study Sites (1)

London Regional Health Science Centre

London, Ontario, N6A 5A5, Canada

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

The Investigators propose collecting two blood samples of 10 mL each from healthy donors and patients in two tubes containing the anticoagulants heparin and ethylenediaminetetraacetic acid (EDTA), respectively. Blood collection and immediate processing have a higher impact on the results of research and laboratory studies. Collected blood samples will be layered over lymphoprep (Stemcell Technologies) in SepMateTM tubes (Stem cell Technologies). Based on density gradient centrifugation the PBMC is isolated by centrifugation, at 2000 rpm for 10 min, transferred, and washed with RPMI media for 5 mins at 1500 rpm. The collected PBMCs are cryopreserved at -196˚C at the C3RP facility.

MeSH Terms

Conditions

Cardiovascular Diseases; Arrhythmias, Cardiac; Cardiomyopathies; Heart Failure; Stroke; Heart Defects, Congenital; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Heart Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 17, 2024
• Study Start: May 1, 2024
• Primary Completion (Estimated): June 30, 2033
• Study Completion (Estimated): June 30, 2033
• Last Updated: May 29, 2024

Record last verified: 2024-05

Locations

CA (1)