Arrhythmogenic CardiomyopathySTARTERNCT06352307
Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy
An observational study of Arrhythmogenic Cardiomyopathy, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Arrhythmogenic Cardiomyopathy
- What is being tested?
- Diagnosis of ACM
- How many people
- 1,500 participants
- Where
- 1 siteChina
- Study dates
- 9 Apr 2024to 31 Aug 2032
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients diagnosed with ACM at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.
Who may be able to join
- Age >18 years old.
- The diagnosis of ACM was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
- Patients or their families agreed to participate in the study and authorized informed consent.
Who cannot join
- Incomplete clinical data.
- Do not agree to the inclusion or refuse to authorize the informed consent.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
First Affiliated Hospital of Xi'an Jiantong University
Xi'an, Shaanxi, 710061
Guoliang Li, +86.29.85323869, liguoliang_med@163.com
Yang Yan, +86.29.85323869, yangyan3@xjtu.edu.cn
About this study
Official title: Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy (STARTER): a Multicenter Retro-prospective Cohort Study
This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.
Read the detailed description
This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.
- Conditions
- Arrhythmogenic Cardiomyopathy
- Being tested
- Diagnosis of ACM
- Keywords
- Arrhythmogenic cardiomyopathy, Prognostic factors
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Diagnosis of ACMOther
Definite ACM diagnosis is based on the consensus-based 2010 Task Force Criteria, which include major and minor criteria in six categories (depolarization and repolarization abnormalities, arrhythmia, imaging, histology, and family history/genetics). Among these, repolarization abnormalities (T-wave inversion in the precordial leads) constitute the most commonly observed, followed by frequent premature ventricular complex. With regards to imaging techniques, both the presence of wall motion abnormalities and an abnormal ventricular volume or function are required for fulfilment. Definite ACM consists of two major criteria or one major and two minor criteria or four minor criteria from different categories. Borderline ACM consists of one major and one minor criterion or three minor criteria from different categories.
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular ACM group | The patients mainly had right ventricular enlargement and right ventricular fibrous adipose tissue replacement, and were diagnosed with right ventricular ACM. Receives: Other: Diagnosis of ACM | |
| Left ventricular ACM group | The patients mainly had left ventricular enlargement and left ventricular fibroadipose tissue replacement, and were diagnosed with left ventricular ACM. Receives: Other: Diagnosis of ACM | |
| Biventricular ACM group | The patients mainly had biventricular enlargement and fibroadipose tissue replacement, and were diagnosed with biventricular ventricular ACM. Receives: Other: Diagnosis of ACM |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of mortality rate
The survival status will be obtained from the medical records and phone calls to patients or their family members.
Measured: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2024
- Study start9 Apr 2024
- Primary completion31 Aug 2030 (estimated)
- Study completion31 Aug 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arrhythmogenic 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06352307
- Sponsor's protocol ID
- XJTU1AF2023LSK-532
- Acronym
- STARTER
- Status last verified
- Jul 2024
- First submitted
- 2 Apr 2024
- Last updated
- 12 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification, Early Prevention and Treatment Strategies for Arrhythmogenic Cardiomyopathy (STARTER): a Multicenter Retro-prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06352307
- Acronym / sponsor ID
- STARTER / XJTU1AF2023LSK-532
- Conditions
- Arrhythmogenic Cardiomyopathy
- Keywords
- Arrhythmogenic cardiomyopathy, Prognostic factors
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 9 Apr 2024 (actual)
- Primary completion
- 31 Aug 2030 (estimated)
- Study completion
- 31 Aug 2032 (estimated)
- First posted
- 8 Apr 2024 (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.
This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.
Detailed description
This study will include patients diagnosed with Arrhythmogenic cardiomyopathy (ACM) in the First Affiliated Hospital of Xi 'an Jiaotong University and other centers, and collect clinical data and biological samples of patients with different ACM phenotypes. Through the establishment of disease cohort and long-term follow-up, to explore the disease characteristics, development law, clinical characteristics, natural course of disease and long-term prognosis of ACM.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Right ventricular ACM group | – | Other: Diagnosis of ACMThe patients mainly had right ventricular enlargement and right ventricular fibrous adipose tissue replacement, and were diagnosed with right ventricular ACM. |
| Left ventricular ACM group | – | Other: Diagnosis of ACMThe patients mainly had left ventricular enlargement and left ventricular fibroadipose tissue replacement, and were diagnosed with left ventricular ACM. |
| Biventricular ACM group | – | Other: Diagnosis of ACMThe patients mainly had biventricular enlargement and fibroadipose tissue replacement, and were diagnosed with biventricular ventricular ACM. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients diagnosed with ACM at all centers including The First Affiliated Hospital of Xi'an Jiaotong University.
Key inclusion criteria (3 listed)
- Age >18 years old.
- The diagnosis of ACM was confirmed by cardiac ultrasound, electrocardiogram, magnetic resonance angiography, pathological examination and gene sequencing.
- Patients or their families agreed to participate in the study and authorized informed consent.
Key exclusion criteria (2 listed)
- Incomplete clinical data.
- Do not agree to the inclusion or refuse to authorize the 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diagnosis of ACMDefinite ACM diagnosis is based on the consensus-based 2010 Task Force Criteria, which include major and minor criteria in six categories (depolarization and repolarization abnormalities, arrhythmia, imaging, histology, and family history/genetics). Among these, repolarization abnormalities (T-wave inversion in the precordial leads) constitute the most commonly observed, followed by frequent premature ventricular complex. With regards to imaging techniques, both the presence of wall motion abnormalities and an abnormal ventricular volume or function are required for fulfilment. Definite ACM consists of two major criteria or one major and two minor criteria or four minor criteria from different categories. Borderline ACM consists of one major and one minor criterion or three minor criteria from different categories. | Other | Biventricular ACM group, Left ventricular ACM group, Right ventricular ACM group |
Primary outcome
Change in the incidence of mortality rate
Time frame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.
The survival status will be obtained from the medical records and phone calls to patients or their family members.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2024.
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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.
Yang Yan principal investigator
First Affiliated Hospital Xi'an Jiaotong University
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 Arrhythmogenic Cardiomyopathy, run by First Affiliated Hospital Xi'an Jiaotong 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 3 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 12 Jul 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yang Yan (+86.29.85323869, yangyan3@xjtu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the incidence of mortality rate (time frame: At diagnosis, before discharge (about 7 days), 1, 3, 6, 9 month, 1, 2, 3 year.). 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 12 Jul 2024.