Biomarkers of Inherited Cardiovascular Conditions
1 other identifier
observational
10
1 country
1
Brief Summary
The National Heart Centre Singapore has recently created a biorepository that is IRB approved for the use in genetic studies: "molecular and imaging studies of cardiovascular health and disease (CIRB Ref: 2013/605/C)". This repository enables IRB approved projects within the National Heart Centre Singapore to access the samples for use in biomarker or genetic studies with consent from patients for these studies. The IRB approved biorepository process also allows for patients, when they have consented to this, to be approached for inclusion in additional studies at National Heart Centre Singapore. In this study, the investigators will examine the genetic variation in genes known to cause inherited cardiac conditions and also look for circulating biomarkers (ICC) in 600 patients with ICC and in 500 patients with ischemic heart disease (e.g.IHD) who will be used as controls. Healthy controls will also be used (800) as they become available in the biorepository. All samples have already been collected in the NHCS biorepository. These patients would have been recruited and consented to the biorepository. This will enable all to better understand heart disease in Singaporean patients. In addition, the investigators will invite a subset of 10 patients with ICCs to provide a second blood sample (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository. The second blood sample will be used for antibody biomarkers that will be developed in the basic science laboratories. These antibodies will be used to develop new biomarkers of human heart disease to improve human health.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for all trials
Started Jan 2014
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 31, 2016
CompletedFirst Posted
Study publicly available on registry
June 17, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2020
CompletedJune 17, 2016
May 1, 2016
6.9 years
May 31, 2016
June 14, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Biomarkers of inherited cardiovascular conditions from genetic variation in genes known to cause inherited cardiac conditions.
5 years
Interventions
10 patients with ICCs to provide a second blood sample (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository.
Eligibility Criteria
The investigators will use DNA samples from 600 patients with known ICC diseases (e.g. Brugada syndrome, long QT syndrome, hypertrophic and dilated cardiomyopathy) and 500 ischemic controls who have been recruited or will be recruited to the NHCS biorepository. For antibody studies, the investigators will invite 10 patients with phenotypes of interest (e.g. myocardial fibrosis or previous myocardial infarction) whom have consented to the biorepository to provide an additional 20mls (2 tablespoons).
You may qualify if:
- Patients with ICC.
- Patients with available cardiac/ cardiovascular imaging.
- Patients with phenotypes of interest (e.g. myocardial fibrosis, previous infarction).
- Age ≥ 21 years and ≤ 80 years.
You may not qualify if:
- Patients with HIV or hepatitis B or hepatitis C.
- Patients with active autoimmune disease.
- Patients who are unable or unwilling to provide consent.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Heart Centre Singapore
Singapore, Singapore, 169609, Singapore
Biospecimen
For antibody studies, the investigators will invite 10 patients with phenotypes of interest (e.g. myocardial fibrosis or previous myocardial infarction) whom have consented to the biorepository to provide an additional 20mls (2 tablespoons).
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Stuart A Cook, PHD
National Heart Centre Singapore
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
May 31, 2016
First Posted
June 17, 2016
Study Start
January 1, 2014
Primary Completion
December 1, 2020
Study Completion
December 1, 2020
Last Updated
June 17, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will not share