Multi-modality EchocardiographyNCT06172842
Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease
An observational study of Multi-modality Echocardiography and Primary Electrical Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
Trial summary
From 2020 to 2023, patients with primary electrical disease (idiopathic ventricular fibrillation, long QT syndrome, Andersen-Tawil syndrome type I, Brugada syndrome, early repolarization syndrome, CPVT, and short QT syndrome) were first diagnosed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and clinical… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Multi-modality Echocardiography, Primary Electrical Disease
- What is being tested?
- Echocardiography
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Jan 2024to Oct 2026
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: primary electrical disease
Who may be able to join
- primary electrical disease
Who cannot join
- Congenital heart disease, poor echocardiographic images, moderate or severe valvular disease
Trial locations and contacts
1 site in 1 country.
About this study
From 2020 to 2023, patients with primary electrical disease (idiopathic ventricular fibrillation, long QT syndrome, Andersen-Tawil syndrome type I, Brugada syndrome, early repolarization syndrome, CPVT, and short QT syndrome) were first diagnosed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and clinical data and echocardiographic indicators were recorded. Follow-up is until December 30, 2025 or endpoint event occurs. Endpoint events were defined as sustained ventricular tachycardia, ventricular fibrillation, sudden cardiac death, ICD discharge events, all-cause death, heart failure and heart transplantation, which were statistically analyzed as a composite endpoint of cardiovascular analysis. The predictors of primary electrical disease and the risk factors for adverse cardiovascular events were analyzed.
- Being tested
- Echocardiography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EchocardiographyDiagnostic test
Multi-modality echocardiography
| Study group | Role | What they receive |
|---|---|---|
| primary electrical disease | Not described Receives: Diagnostic Test: Echocardiography | |
| control | Not described Receives: Diagnostic Test: Echocardiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multi-modality echocardiography
tissue Doppler imging, speckle-tracking-strain, myocardial work, mechanical dispersion,electro-mechanical window
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study startJan 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionOct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Multi-modality EchocardiographyStudies of the same condition, open and under way.
- More trials run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityThe sponsor's other registered studies.
- 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-control
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172842
- Sponsor's protocol ID
- SYSKY-2023-1069-01
- Status last verified
- Jan 2024
- First submitted
- 24 Nov 2023
- Last updated
- 23 Jan 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multi-modality Echocardiography for Cardiac Assessment in Primary Electrical Disease
- ClinicalTrials.gov ID
- NCT06172842
- Acronym / sponsor ID
- SYSKY-2023-1069-01
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sun Yat-Sen Memorial Hospital of Sun Yat-Sen UniversityUniversity, hospital or other
- Study start
- Jan 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 15 Dec 2023 (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.
From 2020 to 2023, patients with primary electrical disease (idiopathic ventricular fibrillation, long QT syndrome, Andersen-Tawil syndrome type I, Brugada syndrome, early repolarization syndrome, CPVT, and short QT syndrome) were first diagnosed at Sun Yat-sen Memorial Hospital of Sun Yat-sen University, and clinical data and echocardiographic indicators were recorded. Follow-up is until December 30, 2025 or endpoint event occurs. Endpoint events were defined as sustained ventricular tachycardia, ventricular fibrillation, sudden cardiac death, ICD discharge events, all-cause death, heart failure and heart transplantation, which were statistically analyzed as a composite endpoint of cardiovascular analysis. The predictors of primary electrical disease and the risk factors for adverse cardiovascular events were analyzed.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| primary electrical disease | – | Diagnostic Test: Echocardiography |
| control | – | Diagnostic Test: Echocardiography |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- primary electrical disease
Key inclusion criteria (1 listed)
- primary electrical disease
Key exclusion criteria (1 listed)
- Congenital heart disease, poor echocardiographic images, moderate or severe valvular disease
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 |
|---|---|---|
| EchocardiographyMulti-modality echocardiography | Diagnostic test | control, primary electrical disease |
Primary outcome
Multi-modality echocardiography
Time frame: 2 years
tissue Doppler imging, speckle-tracking-strain, myocardial work, mechanical dispersion,electro-mechanical window
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2024.
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.
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 Multi-modality Echocardiography and Primary Electrical Disease, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.
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: status not confirmed, as of the sponsor's last update on 23 Jan 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 China. 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 hanlu lv (13430268178, lv-hl@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multi-modality echocardiography (time frame: 2 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 23 Jan 2024.