STEMI - ST Elevation Myocardial InfarctionTregCMRRSNCT03939338
Combination With Treg Levels and CMR to Assess the Severity and Prognosis of Reperfusion Injury After PPCI in STEMI Patients
An observational study of STEMI - ST Elevation Myocardial Infarction and Reperfusion Injury, Myocardial, run by Beijing Friendship Hospital at 1 site in China.
Trial summary
This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- STEMI - ST Elevation Myocardial Infarction, Reperfusion Injury, Myocardial
- What is being tested?
- Treg levels and CMR results
- How many people
- 250 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2019to 31 Aug 2021
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention
Who may be able to join
- Confirmed STEMI diagnosis
- Undergoing primary percutaneous coronary intervention (presenting <12 hours after symptom onset)
- Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations
- Patients agreed and provided informed consent
Who cannot join
- Previous myocardial infarction or revascularization (PCI or CABG)
- Congestive heart failure with LVEF<40%
- Atrial fibrillation
- Renal insufficiency (GFR < 30 ml/min/1.73m^2)
- Acute infectious diseases within nearly 3 months
- Rheumatic immune system diseases
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- Malignant tumors
- Claustrophobia
- Contraindicated to CMR
- Patients do not agree to be included in the study
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, 100050
Bing Hua, M.D., 0086 10 63139795, HuaBing199008@aliyun.com
About this study
Official title: Combination With Regulatory T Cell Levels and Cardiac Magnetic Resonance Imaging (CMR) to Assess the Severity and Prognosis of Reperfusion Injury After Primary PCI in STEMI Patients (TregCMRRS)
This study aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).
- Being tested
- Treg levels and CMR results
- Medical subject headings
- ST Elevation Myocardial Infarction, Myocardial Reperfusion Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Treg levels and CMR resultsOther
This is an observational study. Exposure: Different Treg levels and CMR results.
| Study group | Role | What they receive |
|---|---|---|
| Participates | Not described Receives: Other: Treg levels and CMR results |
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE (major adverse cardiovascular events)
nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death
Measured: 12 months
Secondary outcomes (1)
adverse cardiac remodeling
a cut-off value of 12% change in left ventricular end-diastolic volume between the acute and follow-up magnetic resonance scans
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2019
- Study start1 Jul 2019 (estimated)
- Primary completion31 Aug 2021 (estimated)
- Study completion31 Aug 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for STEMI - ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Beijing Friendship HospitalThe 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
- Prospective
- Enrolment
- 250 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing Friendship Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hongwei Li, MD, Beijing Friendship Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03939338
- Sponsor's protocol ID
- BFH-Treg and CMR
- Acronym
- TregCMRRS
- Status last verified
- Jun 2019
- First submitted
- 3 May 2019
- Last updated
- 26 Jun 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Li J, Xin Y, Lan D, Zhang Y, Hua B, Li H, Li W, Chen H. The Predictive Effects of ECG and QFR in the Detection of Microvascular Obstruction in Patients With STEMI After PPCI. Catheter Cardiovasc Interv. 2025 Jul;106(1):481-493. doi: 10.1002/ccd.31564. Epub 2025 May 4.
PubMed 40320731Zhang Y, Gao H, Liu L, Li S, Hua B, Lan D, He Y, Li J, Chen H, Li W, Li H. Regulatory T Cell as Predictor of Intramyocardial Hemorrhage in STEMI Patients after Primary PCI. Rev Cardiovasc Med. 2023 Jul 14;24(7):205. doi: 10.31083/j.rcm2407205. eCollection 2023 Jul.
PubMed 39077002
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Combination With Regulatory T Cell Levels and Cardiac Magnetic Resonance Imaging (CMR) to Assess the Severity and Prognosis of Reperfusion Injury After Primary PCI in STEMI Patients (TregCMRRS)
- ClinicalTrials.gov ID
- NCT03939338
- Acronym / sponsor ID
- TregCMRRS / BFH-Treg and CMR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 250 participants (estimated)
- Lead sponsor
- Beijing Friendship HospitalUniversity, hospital or other
- Study start
- 1 Jul 2019 (estimated)
- Primary completion
- 31 Aug 2021 (estimated)
- Study completion
- 31 Aug 2021 (estimated)
- First posted
- 6 May 2019 (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 aims to determine whether combination with regulatory T cell (Treg) levels and cardiac magnetic resonance imaging (CMR) are predictive of the severity of reperfusion injury following myocardial infarction and the prognosis in STEMI patients receiving primary percutaneous coronary intervention (PPCI).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participates | – | Other: Treg levels and CMR results |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients admitted to Beijing Friendship Hospital,Capital Medical University with a confirmed STEMI diagnosis undergoing primary percutaneous coronary intervention
Key inclusion criteria (4 listed)
- Confirmed STEMI diagnosis
- Undergoing primary percutaneous coronary intervention (presenting <12 hours after symptom onset)
- Patients were able to complete cardiac magnetic resonance imaging (CMR) and speckle tracking imaging echocardiogram (STE) examinations
- Patients agreed and provided informed consent
Key exclusion criteria (10 listed)
- Previous myocardial infarction or revascularization (PCI or CABG)
- Congestive heart failure with LVEF<40%
- Atrial fibrillation
- Renal insufficiency (GFR < 30 ml/min/1.73m^2)
- Acute infectious diseases within nearly 3 months
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 |
|---|---|---|
| Treg levels and CMR resultsThis is an observational study. Exposure: Different Treg levels and CMR results. | Other | Participates |
Primary outcome
MACE (major adverse cardiovascular events)
Time frame: 12 months
nonfatal or fatal myocardial infarction, revascularization, cardiac death, nonfatal or fatal stroke, all cause of death
1 secondary outcome
adverse cardiac remodeling
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2019.
- Derived from this study: PubMed 40320731Li J, Xin Y, Lan D, Zhang Y, Hua B, Li H, Li W, Chen H. The Predictive Effects of ECG and QFR in the Detection of Microvascular Obstruction in Patients With STEMI After PPCI. Catheter Cardiovasc Interv. 2025 Jul;106(1):481-493. doi: 10.1002/ccd.31564. Epub 2025 May 4.
- Derived from this study: PubMed 39077002Zhang Y, Gao H, Liu L, Li S, Hua B, Lan D, He Y, Li J, Chen H, Li W, Li H. Regulatory T Cell as Predictor of Intramyocardial Hemorrhage in STEMI Patients after Primary PCI. Rev Cardiovasc Med. 2023 Jul 14;24(7):205. doi: 10.31083/j.rcm2407205. eCollection 2023 Jul.
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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.
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 STEMI - ST Elevation Myocardial Infarction and Reperfusion Injury, Myocardial, run by Beijing Friendship Hospital 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 4 inclusion and 10 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 26 Jun 2019. 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 Hongwei Li, M.D. (0086 10 63139780, lhw19656@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (major adverse cardiovascular events) (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03939338, which also lists 2 linked publications.
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 26 Jun 2019.