CardiomyopathyNCT02804256
Biomarkers of Inherited Cardiovascular Conditions
An observational study of Cardiomyopathy and Ischemic Heart Disease, run by National Heart Centre Singapore at 1 site in Singapore.
Trial 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)". Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Cardiomyopathy, Ischemic Heart Disease
- What is being tested?
- Blood Sample Collection
- How many people
- 10 participants
- Where
- 1 siteSingapore
- Study dates
- Jan 2014to Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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).
Who may be able to join
- 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.
Who cannot join
- Patients with HIV or hepatitis B or hepatitis C.
- Patients with active autoimmune disease.
- Patients who are unable or unwilling to provide consent.
Trial locations and contacts
1 site in 1 country.
Stuart A Cook, PHD contact
Singapore1 site, 1 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, Singapore, 169609
Nora Neo
nora.neo.w.t@nhcs.com.sg
About this study
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.
Read the 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.
- Conditions
- Cardiomyopathy, Ischemic Heart Disease
- Being tested
- Blood Sample Collection
- Medical subject headings
- Cardiomyopathies, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood Sample CollectionOther
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarkers of inherited cardiovascular conditions from genetic variation in genes known to cause inherited cardiac conditions.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jun 2016 (estimated)
- Study startJan 2014
- Primary completionDec 2020 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CardiomyopathyStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Heart Centre Singapore
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stuart A Cook, PHD, Principal investigator, National Heart Centre Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02804256
- Sponsor's protocol ID
- 2013/933/C
- Status last verified
- May 2016
- First submitted
- 31 May 2016
- Last updated
- 17 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biomarkers of Inherited Cardiovascular Conditions
- ClinicalTrials.gov ID
- NCT02804256
- Acronym / sponsor ID
- 2013/933/C
- Conditions
- Cardiomyopathy, Ischemic Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- National Heart Centre SingaporeUniversity, hospital or other
- Study start
- Jan 2014
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 17 Jun 2016 (estimated)
- 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 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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients with HIV or hepatitis B or hepatitis C.
- Patients with active autoimmune disease.
- Patients who are unable or unwilling 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood Sample Collection10 patients with ICCs to provide a second blood sample (20mls - 2 tablespoons) on top of the samples that will be collected for the biorepository. | Other | – |
Primary outcome
Biomarkers of inherited cardiovascular conditions from genetic variation in genes known to cause inherited cardiac conditions.
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2016.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
Stuart A Cook, PHD contact
Stuart A Cook, PHD principal investigator
National Heart Centre Singapore
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 Cardiomyopathy and Ischemic Heart Disease, run by National Heart Centre Singapore at 1 site in Singapore.
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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 17 Jun 2016. 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 Singapore. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stuart A Cook, PHD (stuart.cook@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Biomarkers of inherited cardiovascular conditions from genetic variation in genes known to cause inherited cardiac conditions. (time frame: 5 years). 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 17 Jun 2016.