iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease (INFERENCE)

May 28, 2024 updated by: Mark Chandy, Lawson Health Research Institute

Blood Biomarkers From Ethnically Diverse Cardiovascular Patients

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.

Study Overview

Status

Recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • Recruiting
        • London Regional Health Science Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
REDCap Database
Time Frame: 10 years
Identify patients with cardiovascular disease from ethnically diverse backgrounds and create a clinical database with REDCap.
10 years
Induced pluripotent stem cell (iPSC) Biobank
Time Frame: 10 years
Reprogram peripheral blood mononuclear cells (PBMC) to iPSCs.
10 years
Differentiation into Cardiovascular lineages
Time Frame: 10 years
Differentiate of iPSCs into different cardiovascular lineages (endothelial cells, smooth muscle cells, cardiomyocytes, etc.)
10 years
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).
10 years
Bioinformatics analysis
Time Frame: 10 years
Bioinformatics analysis of clinical, iPSC disease modeling, and serum omics analysis.
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lawson Health Research Institute

Collaborators

Greenstone Biosciences, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2024

Primary Completion (Estimated)

June 30, 2033

Study Completion (Estimated)

June 30, 2033

Study Registration Dates

First Submitted

April 9, 2024

First Submitted That Met QC Criteria

April 12, 2024

First Posted (Actual)

April 17, 2024

Study Record Updates

Last Update Posted (Actual)

May 29, 2024

Last Update Submitted That Met QC Criteria

May 28, 2024

Last Verified

May 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 120687

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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