Coronary Heart Disease, Susceptibility to, 1NCT05945394
The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human
An observational study of Coronary Heart Disease, Susceptibility to, 1, run by Nanjing Medical University at 1 site in China.
Trial summary
To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Coronary Heart Disease, Susceptibility to, 1
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2023to 31 Dec 2023
- 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: Patients with suspected coronary heart disease who experienced coronary angiography
Who may be able to join
- Patients with suspected coronary heart disease
- patients received coronary angiography
Who cannot join
- NYHA III-IV
- malignant tumor
- acute infection
- thyroid dysfunction
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.
About this study
To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human
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 who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.
- Being tested
- No intervention
- Keywords
- TRAF3IP2, Coronary angiography, coronary deart disease
- Medical subject headings
- Coronary Disease
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 suspected CHD who experienced CAG | Patients with suspected coronary heart disease 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.
stenosis of coronary artery
The stenosis of coronary artery based on the results of coronary angiography
Measured: 1 week
Secondary outcomes (1)
coronary artery calcium
The coronary artery calcification based on the results of coronary angiography
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2023
- Study start1 Sep 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary Heart Disease, Susceptibility to, 1Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 800 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
- Ma Shuren, MD, Study director, NJMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05945394
- Sponsor's protocol ID
- 20230503
- Status last verified
- Sep 2023
- First submitted
- 29 Jun 2023
- Last updated
- 13 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human
- ClinicalTrials.gov ID
- NCT05945394
- Acronym / sponsor ID
- 20230503
- Keywords
- TRAF3IP2, Coronary angiography, coronary deart disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Nanjing Medical UniversityUniversity, hospital or other
- Study start
- 1 Sep 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 14 Jul 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 association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human
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 who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with suspected CHD who experienced CAG | – | Other: No interventionPatients with suspected coronary heart disease 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
- Patients with suspected coronary heart disease who experienced coronary angiography
Key inclusion criteria (2 listed)
- Patients with suspected coronary heart disease
- patients received coronary angiography
Key exclusion criteria (4 listed)
- NYHA III-IV
- malignant tumor
- acute infection
- thyroid dysfunction
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 suspected CHD who experienced CAG |
Primary outcome
stenosis of coronary artery
Time frame: 1 week
The stenosis of coronary artery based on the results of coronary angiography
1 secondary outcome
coronary artery calcium
Time frame: 1 week
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Individual participant dataSharing planned: No
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.
Ma Shuren, MD study director
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 Coronary Heart Disease, Susceptibility to, 1, 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 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: status not confirmed, as of the sponsor's last update on 13 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 Geng Jin, 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?
stenosis of coronary artery (time frame: 1 week). 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 13 Sep 2023; AzTrials last refreshed its copy on 6 Nov 2026.