NCT02804256

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

May 31, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

June 17, 2016

Completed
4.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

June 17, 2016

Status Verified

May 1, 2016

Enrollment Period

6.9 years

First QC Date

May 31, 2016

Last Update Submit

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

Age21 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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).

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

RECRUITING

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).

MeSH Terms

Conditions

CardiomyopathiesMyocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Stuart A Cook, PHD

    National Heart Centre Singapore

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Stuart A Cook, PHD

CONTACT

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

Locations