Inherited Cardiac ConditionsNCT04312230
The Role of Biomarkers in Inherited Cardiac Conditions
An observational study of Inherited Cardiac Conditions, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
Trial summary
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac muscle, vasculature, or conductive system. These conditions sometimes present with sudden cardiac death, and may have significant implications for families. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Inherited Cardiac Conditions
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 2 Nov 2017to 30 Nov 2021
- 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 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: This is an observational study of patients referred clinically to the Inherited Cardiac Conditions clinic at the University Hospital of South Manchester. As part of this study, all patients referred to this clinic will beapproached over a 5 year period. The expectation is to recruit 150 patient per year.
Who may be able to join
- Any adult patient attending the inherited cardiac conditions clinic
Who cannot join
- Age < 16 years, Imprisonment Inability to provide informed consent.
Trial locations and contacts
1 site in 1 country.
About this study
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac muscle, vasculature, or conductive system. These conditions sometimes present with sudden cardiac death, and may have significant implications for families. Whilst their prevalence may be rare, our understanding of these conditions has increased over the past decade. ICC Clinics aim to improve the diagnosis, treatment and outcomes of these patients.
The NIH has defined a biomarker as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention". Biomarkers can indicate disease characteristics, including markers of clinical disease, or indicators of therapeutic response.
This study aims to investigate the utility of biomarkers in a large cohort of patients who are attending the ICC clinic. Biomarkers will be related to the presence and severity of cardiovascular disease and other markers of cardiac disease.
Read the detailed description
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac muscle, vasculature, or conductive system. More than 50 ICCs have been recognised and our diagnostic capabilities ever improve. However, whilst our understanding of ICCs and their molecular basis has increased, management of these conditions remains challenging owing to their heterogeneity, both genetically and clinically. ICC clinics aim to improve and standardise the care of patients with ICCs but improving diagnosis, risk stratification, and management, and by coordinating specialist care provided by other specialities. The UHSM ICC clinic has recently been established, providing tertiary care for patients across a large geographical area. As such, it is well placed is well placed to do this study.
Sudden cardiac death may be the first presentation of ICC, and a new diagnosis has significant implications for families. Risk may be augmented by a multitude of clinical and genetic factors, and there is an increasing need for tools that may be used by clinicians to identify patients at increased risk. Biomarkers are one such tool which may be able to assist in the complex identification of high-risk individuals, to effectively prognosticate and monitor treatment patients with disease.
As part of this study, all patients due to attend the ICC at USHM will be approached over a 5 year period. The expectation is to recruit 750 patients. Patients will undergo their clinic appointments in the usual manner. As part of the study, a peripheral blood sample of approximately 10mL will be taken to allow measurement of cardiac biomarkers in order to further characterise cardiovascular status and to relate clinical findings to other markers of cardiac disease. Biomarker levels will be related to the presence and severity of cardiovascular disease, at the time of the clinic visit and over subsequent 10 year follow-up, as documented by validated health status questionnaires and information in patients' medical records.
This is an observational study of patients referred clinically to the Inherited Cardiac Conditions clinic at the University Hospital of South Manchester.
As part of this study, all patients referred to this clinic will be approached over a 5 year period. The expectation is to recruit 150 patient per year.Patients will attend clinic and other related clinically indicated appointments in the usual manner. As part of the study, a blood sample of approximately 10mL will be taken from the patients arm to allow measurement of cardiac biomarkers in order to further characterise cardiovascular status and to relate these findings to other markers of cardiac disease.
The patient will also be asked to complete a questionnaire about their symptoms and quality of life.
- Conditions
- Inherited Cardiac Conditions
What is being measured
The primary outcome is the main question the study is designed to answer.
To establish to role of biomarkers in inherited cardiac conditions
Biomarker profile of patients with cardiomyopathy. Describe the circulating biomarker characteristics of patients with cardiomyopathy, including troponin
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 posted18 Mar 2020
- Study start2 Nov 2017
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Why it stopped: Funder has ceased trading and all clinical consultations now held virtually due to COVID
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Inherited Cardiac ConditionsStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Manchester University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Christopher Miller, MBChB PhD, Principal investigator, Manchester University NHS FT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04312230
- Sponsor's protocol ID
- ICC-01
- Status last verified
- Nov 2024
- First submitted
- 1 Feb 2019
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Biomarkers in Inherited Cardiac Conditions
- ClinicalTrials.gov ID
- NCT04312230
- Acronym / sponsor ID
- ICC-01
- Conditions
- Inherited Cardiac Conditions
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Funder has ceased trading and all clinical consultations now held virtually due to COVID
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Manchester University NHS Foundation TrustOther government
- Study start
- 2 Nov 2017 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 18 Mar 2020 (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.
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac muscle, vasculature, or conductive system. These conditions sometimes present with sudden cardiac death, and may have significant implications for families. Whilst their prevalence may be rare, our understanding of these conditions has increased over the past decade. ICC Clinics aim to improve the diagnosis, treatment and outcomes of these patients.
The NIH has defined a biomarker as "a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention". Biomarkers can indicate disease characteristics, including markers of clinical disease, or indicators of therapeutic response.
This study aims to investigate the utility of biomarkers in a large cohort of patients who are attending the ICC clinic. Biomarkers will be related to the presence and severity of cardiovascular disease and other markers of cardiac disease.
Detailed description
Inherited cardiac conditions (ICC) comprise any hereditary condition which may affect cardiac muscle, vasculature, or conductive system. More than 50 ICCs have been recognised and our diagnostic capabilities ever improve. However, whilst our understanding of ICCs and their molecular basis has increased, management of these conditions remains challenging owing to their heterogeneity, both genetically and clinically. ICC clinics aim to improve and standardise the care of patients with ICCs but improving diagnosis, risk stratification, and management, and by coordinating specialist care provided by other specialities. The UHSM ICC clinic has recently been established, providing tertiary care for patients across a large geographical area. As such, it is well placed is well placed to do this study.
Sudden cardiac death may be the first presentation of ICC, and a new diagnosis has significant implications for families. Risk may be augmented by a multitude of clinical and genetic factors, and there is an increasing need for tools that may be used by clinicians to identify patients at increased risk. Biomarkers are one such tool which may be able to assist in the complex identification of high-risk individuals, to effectively prognosticate and monitor treatment patients with disease.
As part of this study, all patients due to attend the ICC at USHM will be approached over a 5 year period. The expectation is to recruit 750 patients. Patients will undergo their clinic appointments in the usual manner. As part of the study, a peripheral blood sample of approximately 10mL will be taken to allow measurement of cardiac biomarkers in order to further characterise cardiovascular status and to relate clinical findings to other markers of cardiac disease. Biomarker levels will be related to the presence and severity of cardiovascular disease, at the time of the clinic visit and over subsequent 10 year follow-up, as documented by validated health status questionnaires and information in patients' medical records.
This is an observational study of patients referred clinically to the Inherited Cardiac Conditions clinic at the University Hospital of South Manchester.
As part of this study, all patients referred to this clinic will be approached over a 5 year period. The expectation is to recruit 150 patient per year.Patients will attend clinic and other related clinically indicated appointments in the usual manner. As part of the study, a blood sample of approximately 10mL will be taken from the patients arm to allow measurement of cardiac biomarkers in order to further characterise cardiovascular status and to relate these findings to other markers of cardiac disease.
The patient will also be asked to complete a questionnaire about their symptoms and quality of life.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- This is an observational study of patients referred clinically to the Inherited Cardiac Conditions clinic at the University Hospital of South Manchester. As part of this study, all patients referred to this clinic will beapproached over a 5 year period. The expectation is to recruit 150 patient per year.
Key inclusion criteria (1 listed)
- Any adult patient attending the inherited cardiac conditions clinic
Key exclusion criteria (1 listed)
- Age < 16 years, Imprisonment Inability to provide informed 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
To establish to role of biomarkers in inherited cardiac conditions
Time frame: 5 years
Biomarker profile of patients with cardiomyopathy. Describe the circulating biomarker characteristics of patients with cardiomyopathy, including troponin
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Nov 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. This study is not recruiting at the moment.
Christopher Miller, MBChB PhD principal investigator
Manchester University NHS FT
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 Inherited Cardiac Conditions, run by Manchester University NHS Foundation Trust at 1 site in United Kingdom.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 27 Nov 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 United Kingdom. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To establish to role of biomarkers in 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 27 Nov 2024.