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NCT Number: NCT06371937

iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. REDCap Database

    Time frame: 10 years

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

  2. Induced pluripotent stem cell (iPSC) Biobank

    Time frame: 10 years

    Reprogram peripheral blood mononuclear cells (PBMC) to iPSCs.

  3. Differentiation into Cardiovascular lineages

    Time frame: 10 years

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

  4. Molecular profiling of participants

    Time frame: 10 years

    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).

  5. Bioinformatics analysis

    Time frame: 10 years

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

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • Greenstone Biosciences, Inc.

Registry information

Official study title

Blood Biomarkers From Ethnically Diverse Cardiovascular Patients

Acronym: INFERENCE

Important dates

Study start
2024
Primary completion
2033
Study completion
2033
First posted
Apr 17, 2024
Registry last updated
May 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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