Myocardial Infarction, AcuteNCT06038994
Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
An observational study of Myocardial Infarction, Acute, run by Nanjing Medical University at 1 site in China.
Trial summary
To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Myocardial Infarction, Acute
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 30 Apr 2025
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with acute myocardial infarction who received coronary angiography well enrolled in Huai'an First People's Hospital
Who may be able to join
- Patients with acute myocardial infarction
- patients received coronary angiography
- invasive management within 72 h of hospital admission
Who cannot join
- NYHA III-IV
- malignant tumor
- acute infection
- thyroid dysfunction
- Life expectancy of b1 y
- Unsuitable for PCI
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Huai'an First People's Hospital
Huai'an, Jiangsu, 223300
Xiaozhong Yang, MD., +8684922412
About this study
To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction
Read the detailed description
Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients diagnosed with acute myocardial infarction who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- No intervention
- Keywords
- TRAF3IP2, Myocardial Infarction, Coronary angiography, MACEs
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
This is an obvertional study, and there is no intervention.
| Study group | Role | What they receive |
|---|---|---|
| Patients with acute myocardial infarction who experienced CAG | Patients with acute myocardial infarction who experienced coronary angiography Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACEs (major adverse cardiac events)
MACEs were defined as a composite of cardiac death, hospitalization for myocardial infarction or heart failure
Measured: 1 year
Secondary outcomes (2)
cardiac death
and death due to cardiac reasons, such as myocardial infarction or heart failure
Measured: 1 year
hospitalization for myocardial infarction or heart failure
hospitalization for myocardial infarction or heart failure
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Sep 2023
- Study start1 Sep 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies of the same condition, open and under way.
- More trials run by Nanjing Medical 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 only
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nanjing Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin Geng, Nanjing Medical University
- Investigators
- Shuren Ma, MD., Principal investigator, NJMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06038994
- Sponsor's protocol ID
- 20230901
- Status last verified
- Sep 2023
- First submitted
- 7 Sep 2023
- Last updated
- 15 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is not a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction
- ClinicalTrials.gov ID
- NCT06038994
- Acronym / sponsor ID
- 20230901
- Conditions
- Myocardial Infarction, Acute
- Keywords
- TRAF3IP2, Myocardial Infarction, Coronary angiography, MACEs
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2025 (estimated)
- First posted
- 15 Sep 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.
To evaluate the prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction
Detailed description
Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients diagnosed with acute myocardial infarction who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the major adverse cardiac events will be evaluated.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with acute myocardial infarction who experienced CAG | – | Other: No interventionPatients with acute myocardial infarction who experienced coronary angiography |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with acute myocardial infarction who received coronary angiography well enrolled in Huai'an First People's Hospital
Key inclusion criteria (3 listed)
- Patients with acute myocardial infarction
- patients received coronary angiography
- invasive management within 72 h of hospital admission
Key exclusion criteria (6 listed)
- NYHA III-IV
- malignant tumor
- acute infection
- thyroid dysfunction
- Life expectancy of b1 y
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 |
|---|---|---|
| No interventionThis is an obvertional study, and there is no intervention. | Other | Patients with acute myocardial infarction who experienced CAG |
Primary outcome
MACEs (major adverse cardiac events)
Time frame: 1 year
MACEs were defined as a composite of cardiac death, hospitalization for myocardial infarction or heart failure
2 secondary outcomes
cardiac death
Time frame: 1 year
hospitalization for myocardial infarction or heart failure
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2023.
- Individual participant dataSharing planned: No. There is not a plan to make IPD available.
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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.
Shuren Ma, MD. principal investigator
NJMU
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 Myocardial Infarction, Acute, run by Nanjing Medical 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 6 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 15 Sep 2023. 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 Jin Geng, MD. (+86-17753124846, gj885258@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACEs (major adverse cardiac events) (time frame: 1 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 15 Sep 2023.