Early Repolarization SyndromeNCT02847039
Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study
An observational study of Early Repolarization Syndrome, run by Nantes University Hospital at 1 site in France.
Trial summary
The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular… Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Early Repolarization Syndrome
- What is being tested?
- Blood samples
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2008to 31 Dec 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 Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified.
Who may be able to join
- Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral.
- Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome.
- Late potentials ventricular analyzable.
- For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation.
- For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test.
Who cannot join
- Impossibility to receive clear information (patient's intellectual default).
- Refusal to sign the informed consent for participation.
- Under protective measure of justice.
Trial locations and contacts
1 site in 1 country.
About this study
The research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.
To try to answer these many questions, the approach will be twofold: clinical and genetic.
Read more
- Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.
- Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.
- 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.
A blood sample (15 ml) will be performed at inclusion.
- Conditions
- Early Repolarization Syndrome
- Being tested
- Blood samples
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesGenetic
Blood samples at baseline.
| Study group | Role | What they receive |
|---|---|---|
| Early repolarization syndrome | Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified. Receives: Genetic: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of ventricular fibrillation or sudden death
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2016 (estimated)
- Study start1 Jan 2008
- Primary completion31 Dec 2021 (estimated)
- Study completion31 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Repolarization SyndromeStudies 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
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847039
- Sponsor's protocol ID
- PROG/09/62
- Status last verified
- Sep 2021
- First submitted
- 25 Jul 2016
- Last updated
- 9 Sep 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Repolarization Syndrome: Define the Risk, Stratify the Coverage and Understand the Causes - Clinical and Genetic Study
- ClinicalTrials.gov ID
- NCT02847039
- Acronym / sponsor ID
- PROG/09/62
- Conditions
- Early Repolarization Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2008 (actual)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 31 Dec 2021 (estimated)
- First posted
- 27 Jul 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 research project aims to try to answer the many questions raised by the identification of new early repolarization syndrome. The questions are varied with both taking optimal clinical management of patients, the frequency and significance of this anomaly in the population on the electrophysiological and molecular basis responsible for this electrocardiographic abnormality.
To try to answer these many questions, the approach will be twofold: clinical and genetic.
- Establishment of a clinical database containing information of patients who have been identified as carriers of the anomaly based on the initial clinical presentation in order to determine their prognoses.
- Physiological approach will be based on a molecular approach to identify genetic abnormalities may be involved in this syndrome.
- 200 asymptomatic patients and an unlimited number of patients who presented syncope or aborted sudden death will be included.
A blood sample (15 ml) will be performed at inclusion.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Early repolarization syndrome | – | Genetic: Blood samplesPatients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified. |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients with an aspect of early repolarization syndrome or belonging to a family in which the diagnosis of early repolarization was identified.
Key inclusion criteria (5 listed)
- Presence of early repolarization aspect, determined by the J point elevation of at least 0.1 mV above the isoelectric line, with or without extra-ST segment elevation in at least two leads and / or lateral.
- Parameters ECG D2 level of the bypass measurable for the presence of long QT syndrome.
- Late potentials ventricular analyzable.
- For patients with ventricular fibrillation, negative search for other causes of ventricular fibrillation.
- For patients with syncope, clinical assessment should included at a minimum, performing a cardiac ultrasound and a stress test.
Key exclusion criteria (3 listed)
- Impossibility to receive clear information (patient's intellectual default).
- Refusal to sign the informed consent for participation.
- Under protective measure of justice.
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 samplesBlood samples at baseline. | Genetic | Early repolarization syndrome |
Primary outcome
Incidence of ventricular fibrillation or sudden death
Time frame: 36 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2021.
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RecruitingObservational study
China Inherited Ventricular Arrhythmias Registry
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Early Repolarization Syndrome, run by Nantes University Hospital at 1 site in France.
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 5 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 9 Sep 2021. 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 France. 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?
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?
Incidence of ventricular fibrillation or sudden death (time frame: 36 months). 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 9 Sep 2021.