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Biomarkers of Inherited Cardiovascular Conditions

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ClinicalTrials.gov Identifier: NCT02804256
Recruitment Status : Recruiting
First Posted : June 17, 2016
Last Update Posted : June 17, 2016
Sponsor:
Information provided by (Responsible Party):
National Heart Centre Singapore

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.


Condition or disease Intervention/treatment
Cardiomyopathy Ischemic Heart Disease Other: Blood Sample Collection

Detailed Description:

In young adults and children inherited cardiac conditions (ICCs) that affect cardiac structure and electrical activity, account for most cases of sudden cardiac death. Of the ICCs, SCD due to Brugada Syndrome is particularly prevalent in SE Asia where it causes early loss of life in young men. While there have been major advances in the treatment of coronary artery disease (CAD), heart failure (HF) and acute MI, it remains very difficult to identify individuals at risk of SCD due to ICCs even when these diseases run in families and/or the mutation is known. This, in large part, relates to our limited understanding of the effects of gene mutations on clinical phenotypes due to variation in mutation penetrance and expressivity. In Singapore, and SE Asia in general, the issue of mutation interpretation is very difficult, if not impossible, as population-specific variant annotation is limited or completely absent for the common ICC genes. In addition, while DNA variants are important other protein biomarkers in the heart and in the vessels may be equally important, and these remain completely unaddressed in all populations.The investigatorswill address these issue in cases and controls using advanced sequencing and informatics approaches and by generating novel antibody libraries using patient samples.

Overall, the research performed in this study will find new ways of diagnosing patients at risk of sudden death both in the hospital environment and also in the general population. This will enable effective screening and stratification of patients at risk of sudden death due to inherited causes or following myocardial infarction.

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Study Type : Observational
Estimated Enrollment : 10 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Biomarkers of Inherited Cardiovascular Conditions
Study Start Date : January 2014
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Intervention Details:
  • Other: Blood Sample Collection
    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.


Primary Outcome Measures :
  1. Biomarkers of inherited cardiovascular conditions from genetic variation in genes known to cause inherited cardiac conditions. [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
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).


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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).

Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Patients with HIV or hepatitis B or hepatitis C.
  • Patients with active autoimmune disease.
  • Patients who are unable or unwilling to provide consent.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02804256


Contacts
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Contact: Stuart A Cook, PHD stuart.cook@singhealth.com.sg

Locations
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Singapore
National Heart Centre Singapore Recruiting
Singapore, Singapore, 169609
Contact: Nora Neo         
Contact       nora.neo.w.t@nhcs.com.sg   
Sponsors and Collaborators
National Heart Centre Singapore
Investigators
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Principal Investigator: Stuart A Cook, PHD National Heart Centre Singapore

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Responsible Party: National Heart Centre Singapore
ClinicalTrials.gov Identifier: NCT02804256    
Other Study ID Numbers: 2013/933/C
First Posted: June 17, 2016    Key Record Dates
Last Update Posted: June 17, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Heart Diseases
Cardiomyopathies
Myocardial Ischemia
Coronary Artery Disease
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arteriosclerosis
Arterial Occlusive Diseases