Cardiovascular DiseasesINFERENCENCT06371937
iPSC Biobank of Biomarkers Diversity in Cardiovascular Disease
An observational study of Cardiovascular Diseases and Arrythmia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Diseases, Arrythmia, Cardiomyopathies
- How many people
- 200 participants
- Where
- 1 siteCanada
- Study dates
- 1 May 2024to 30 Jun 2033
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: We will recruit 200 participants including 150 patients with cardiovascular disease and 50 healthy control participants.
Who may be able to join
- Adult (18 to 80 years of age)
- Cardiovascular Disease (CVD)
- Cerebrovascular Disease (CBD)
- Peripheral Vascular Disease (PVD)
- Inherited Arrhythmias
- Cardiomyopathies
Show all 10Show fewer
- Congenital Heart Disease (CHD)
- Aortopathy
- Hypertension
- Cardiometabolic Disease (CMD)
Who cannot join
- Younger than 18 years of age.
- Patients not able to provide consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Canada1 site, 1 recruiting
- Recruiting
London Regional Health Science Centre
London, Ontario, N6A 5A5
Mark Chandy, MD PhD, 5196612111, mark.chandy@lhsc.on.ca
About this study
Official title: 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.
Read the 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.
- Conditions
- Cardiovascular Diseases, Arrythmia, Cardiomyopathies, Heart Failure, Cerebrovascular Accident, Congenital Heart Disease
- Medical subject headings
- Cardiovascular Diseases, Arrhythmias, Cardiac, Cardiomyopathies, Heart Failure, Stroke, Heart Defects, Congenital, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
REDCap Database
Identify patients with cardiovascular disease from ethnically diverse backgrounds and create a clinical database with REDCap.
Measured: 10 years
Induced pluripotent stem cell (iPSC) Biobank
Reprogram peripheral blood mononuclear cells (PBMC) to iPSCs.
Measured: 10 years
Differentiation into Cardiovascular lineages
Differentiate of iPSCs into different cardiovascular lineages (endothelial cells, smooth muscle cells, cardiomyocytes, etc.)
Measured: 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).
Measured: 10 years
Bioinformatics analysis
Bioinformatics analysis of clinical, iPSC disease modeling, and serum omics analysis.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Apr 2024
- Study start1 May 2024
- Primary completion30 Jun 2033 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Collaborators
- Greenstone Biosciences, Inc.
- Responsible party
- Principal investigator, Mark Chandy, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06371937
- Sponsor's protocol ID
- 120687
- Acronym
- INFERENCE
- Status last verified
- May 2024
- First submitted
- 9 Apr 2024
- Last updated
- 29 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Blood Biomarkers From Ethnically Diverse Cardiovascular Patients
- ClinicalTrials.gov ID
- NCT06371937
- Acronym / sponsor ID
- INFERENCE / 120687
- Conditions
- Cardiovascular Diseases, Arrythmia, Cardiomyopathies, Heart Failure, Cerebrovascular Accident, Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Collaborators
- Greenstone Biosciences, Inc.
- Study start
- 1 May 2024 (actual)
- Primary completion
- 30 Jun 2033 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 17 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- We will recruit 200 participants including 150 patients with cardiovascular disease and 50 healthy control participants.
Key inclusion criteria (10 listed)
- Adult (18 to 80 years of age)
- Cardiovascular Disease (CVD)
- Cerebrovascular Disease (CBD)
- Peripheral Vascular Disease (PVD)
- Inherited Arrhythmias
Key exclusion criteria (2 listed)
- Younger than 18 years of age.
- Patients not able to provide consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
REDCap Database
Time frame: 10 years
Identify patients with cardiovascular disease from ethnically diverse backgrounds and create a clinical database with REDCap.
Induced pluripotent stem cell (iPSC) Biobank
Time frame: 10 years
Reprogram peripheral blood mononuclear cells (PBMC) to iPSCs.
Differentiation into Cardiovascular lineages
Time frame: 10 years
Differentiate of iPSCs into different cardiovascular lineages (endothelial cells, smooth muscle cells, cardiomyocytes, etc.)
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).
Bioinformatics analysis
Time frame: 10 years
Bioinformatics analysis of clinical, iPSC disease modeling, and serum omics analysis.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases and Arrythmia, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 29 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
REDCap Database (time frame: 10 years). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2024.