MyocarditisFORWARDNCT06010199
Risk Stratification Value of Biomarkers in Patients With Myocarditis
An observational study of Myocarditis, run by First Affiliated Hospital Xi'an Jiaotong University at 1 site in China.
Trial summary
The aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis. Read more about this study
- Who is it for?
- Ages 3 to 80 years
- Conditions the study is for
- Myocarditis
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 25 Aug 2023to 31 Aug 2030
- 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 3 to 80 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All hospitalized patients who meet the diagnostic criteria for myocarditis and undergo regular follow-up at the corresponding cardiovascular center are included in the study.
Who may be able to join
- All patients should meet the diagnostic criteria for myocarditis
- Patients who are regularly followed up at the corresponding cardiovascular center
Who cannot join
- Age <3 years or >80 years
- Pregnant or lactating women
- The patient refused to sign the informed consent and refused to participate in the study
- None of the above is consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal representative to sign it instead. Depending on the condition, the patient may not wake up to sign 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 Jiaotong University
Xi'an, Shaanxi, 710061
Guoliang Li, liguoliang_med@163.com
Yang Yan, +862985323865, yangyan3@xjtu.edu.cn
About this study
Official title: Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study
The aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis.
Read the detailed description
The aim of this study is to retrospectively and prospectively collect clinical data and biological specimens from patients with myocarditis who meet the inclusion and exclusion criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing, methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome conformation capture and other techniques are used to construct a prognosis prediction model for myocarditis.
- Conditions
- Myocarditis
- Keywords
- Myocarditis, Biomarker, Risk stratification
- Medical subject headings
- Myocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Myocarditis group | All enrolled patients are administered antiviral drugs, glucocorticoids, immunoglobulins, and other standard treatments. Additionally, the decision to provide ECMO support therapy is based on the severity of the patient's condition. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the incidence of MACCE
MACE (major adverse cardiovascular events) including all-cause death, myocardial infarction, stroke and coronary revascularization surgery. The MACCE will be assessed from the medical records.
Measured: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Secondary outcomes (4)
Change in the incidence of all-cause death
All-cause death diagnosed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Change in the incidence of myocardial infarction
Myocardial infarction diagnosed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Change in the incidence of stroke
Stroke diagnosed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Change in the incidence of coronary revascularization surgery
Coronary revascularization surgery completed by clinical doctors will be assessed from the medical records
Measured: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start25 Aug 2023
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Aug 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MyocarditisStudies of the same condition, open and under way.
- More trials run by First Affiliated Hospital Xi'an Jiaotong 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
- Cohort
- Time perspective
- Other
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yang Yan, Principal investigator, First Affiliated Hospital Xi'an Jiaotong UniversityGuoliang Li, Principal investigator, First Affiliated Hospital Xi'an Jiaotong University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06010199
- Sponsor's protocol ID
- XJTU1AF2023LSK-169
- Acronym
- FORWARD
- Status last verified
- Mar 2024
- First submitted
- 6 Jul 2023
- Last updated
- 12 Jul 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 12 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Risk Stratification Value of Biomarkers in Patients With Myocarditis (FORWARD): a National, Multicenter, Retrospective-prospective, Cohort Study
- ClinicalTrials.gov ID
- NCT06010199
- Acronym / sponsor ID
- FORWARD / XJTU1AF2023LSK-169
- Conditions
- Myocarditis
- Keywords
- Myocarditis, Biomarker, Risk stratification
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- First Affiliated Hospital Xi'an Jiaotong UniversityUniversity, hospital or other
- Study start
- 25 Aug 2023 (actual)
- Primary completion
- 31 Jul 2030 (estimated)
- Study completion
- 31 Aug 2030 (estimated)
- First posted
- 24 Aug 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.
The aim of this study is to collect clinical data and biological specimens from patients with myocarditis and construct a predictive model for the prognosis of myocarditis.
Detailed description
The aim of this study is to retrospectively and prospectively collect clinical data and biological specimens from patients with myocarditis who meet the inclusion and exclusion criteria. General molecular biology analysis, genome sequencing, transcriptome sequencing, methylation sequencing, metabolomics analysis, proteomics analysis, genome-wide chromosome conformation capture and other techniques are used to construct a prognosis prediction model for myocarditis.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Myocarditis group | – | –All enrolled patients are administered antiviral drugs, glucocorticoids, immunoglobulins, and other standard treatments. Additionally, the decision to provide ECMO support therapy is based on the severity of the patient's condition. |
Who may qualify
- Ages
- 3 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All hospitalized patients who meet the diagnostic criteria for myocarditis and undergo regular follow-up at the corresponding cardiovascular center are included in the study.
Key inclusion criteria (2 listed)
- All patients should meet the diagnostic criteria for myocarditis
- Patients who are regularly followed up at the corresponding cardiovascular center
Key exclusion criteria (4 listed)
- Age <3 years or >80 years
- Pregnant or lactating women
- The patient refused to sign the informed consent and refused to participate in the study
- None of the above is consistent, but the patient cannot sign the informed consent temporarily due to coma and other reasons, and there is no legal representative to sign it instead. Depending on the condition, the patient may not wake up to sign 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.
Primary outcome
Change in the incidence of MACCE
Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
MACE (major adverse cardiovascular events) including all-cause death, myocardial infarction, stroke and coronary revascularization surgery. The MACCE will be assessed from the medical records.
4 secondary outcomes
Change in the incidence of all-cause death
Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Change in the incidence of myocardial infarction
Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Change in the incidence of stroke
Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
Change in the incidence of coronary revascularization surgery
Time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.
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
Guoliang Li 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 Myocarditis, 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 2 inclusion and 4 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 Guoliang Li (+8613759982523, liguoliang_med@163.com), 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 MACCE (time frame: 1, 3, 6 months after enrollment; and 1, 2, 3, 4, 5 years after enrollment.). 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.