ST Elevation Myocardial InfarctionNCT05450757
Shanghai ST-segment Elevation Myocardial Infarction Cohort
An observational study of ST Elevation Myocardial Infarction, run by Ruijin Hospital at 7 sites in China.
Trial summary
ST-segment elevation myocardial infarction(STEMI) remains a major cause of morbidity and mortality worldwide, despite of the early reperfusion therapy, including fibrinolysis, primary percutaneous coronary intervention (PCI),and standardized medical treatment.To improve the prognosis of STEMI patients, the management… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- ST Elevation Myocardial Infarction
- How many people
- 2,000 participants
- Where
- 7 sitesChina
- Study dates
- 12 Sep 2018to 17 Sep 2024
- How long will I take part?
- 5 Years
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is multi-center cohort study. Patients with acute ST elevation myocardial infarction undergo percutaneous coronary intervention within 12 hours of symptom onset at Ruijin Hospital, Minhang district Center Hospital, Yangpu district Center Hospital, Putuo district Center hospital,Jiading district Center Hospital, Fengxian district Center Hospital,and Shanghai Fifth people's Hospital, Shanghai, China are consecutively enrolled.
Who may be able to join
- ST elevation myocardial infarction
- Coronary angiography and percutaneous coronary intervention within 12 hours of symptom onset
- Capable and willing to provide informed conset and capable of completing study visits
Who cannot join
- Cardiovascular shock at admission
- Severe physical disability
- Active malignant tumors
- Active autoimmune diseases
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites, 7 recruiting
- Recruiting
Ruijin hospital, Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
Shuo Feng, M.D., Ph.D.
- Recruiting
Shanghai Fengxian District Central Hospital
Shanghai, Shanghai Municipality
Li Zhang, M.D.
- Recruiting
Shanghai Fifth People's Hospital, Fudan University
Shanghai, Shanghai Municipality
Qi Qiao, M.D.
- Recruiting
Shanghai Jiading District Central Hospital
Shanghai, Shanghai Municipality
Chunya Zhang, M.D.
- Recruiting
Shanghai Minhang District Central Hospital
Shanghai, Shanghai Municipality
Jian Dong, M.D.
- Recruiting
Shanghai Putuo District Central Hospital
Shanghai, Shanghai Municipality
Youlong Xu, M.D.
- Recruiting
Shanghai Yangpu District Central Hospital
Shanghai, Shanghai Municipality
Qunlin Gong, M.D.
About this study
Official title: A Prospective Multicentre Cohort Study of Acute ST-segment Elevation Myocardial Infarction
ST-segment elevation myocardial infarction(STEMI) remains a major cause of morbidity and mortality worldwide, despite of the early reperfusion therapy, including fibrinolysis, primary percutaneous coronary intervention (PCI),and standardized medical treatment.To improve the prognosis of STEMI patients, the management in their hospitalization should be optimized, including improvements in risk stratification, more widespread use of an invasive strategy, implementation of care delivery systems prioritising immediate revascularisation through PCI (or fibrinolysis), advances in antiplatelet agents and anticoagulants, and greater use of secondary prevention strategies such as lipid-lowering therapy.
This study aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.
Read the detailed description
This study is a prospective cohort study. It aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Cardiac Remodelling, Heart Failure
- Medical subject headings
- ST Elevation Myocardial Infarction, Heart Failure
What is being measured
The primary outcome is the main question the study is designed to answer.
MACE
Major adverse cardiovascular events(MACE) in one year follow-up
Measured: 0-1 year
Left Ventricular Function
Left ventricular end diastolic volume(LVEDV),Left ventricular end systolic volume(LVESE),Left ventricular ejection fraction(LVEF) changes within one year follow-up
Measured: 1 month, 6month and 1 year
Coronary angiography
The pathological changes in culprit vessels in 1 year
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 posted11 Jul 2022
- Study start12 Sep 2018
- Primary completion17 Sep 2023 (estimated)
- Study completion17 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ST Elevation Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Ruijin 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
- 2,000 participants (estimated)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, RUIYAN ZHANG, Ruijin Hospital
- Investigators
- Wei Wei Quan, M.D.,Ph.D., Study chair, Ruijin HospitalTian Qi Zhu, M.D.,Ph.D., Study chair, Ruijin HospitalXiao Xiang Yan, M.D.,Ph.D., Study chair, Ruijin HospitalWen Li Zhang, M.D.,Ph.D., Study chair, Ruijin HospitalRun Du, M.D.,Ph.D., Study chair, Ruijin HospitalYing Jia Xu, M.D.,Ph.D., Study chair, Fudan UniversityWei Hu, Study chair, Shanghai Minhang District Central HospitalYimeng Zhou, Study chair, Tongji University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05450757
- Sponsor's protocol ID
- RJH-STEMI
- Status last verified
- Jul 2022
- First submitted
- 2 Jul 2022
- Last updated
- 11 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Cohort Study of Acute ST-segment Elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT05450757
- Acronym / sponsor ID
- RJH-STEMI
- Conditions
- ST Elevation Myocardial Infarction
- Keywords
- Acute Myocardial Infarction, Cardiac Remodelling, Heart Failure
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 12 Sep 2018 (actual)
- Primary completion
- 17 Sep 2023 (estimated)
- Study completion
- 17 Sep 2024 (estimated)
- First posted
- 11 Jul 2022 (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.
ST-segment elevation myocardial infarction(STEMI) remains a major cause of morbidity and mortality worldwide, despite of the early reperfusion therapy, including fibrinolysis, primary percutaneous coronary intervention (PCI),and standardized medical treatment.To improve the prognosis of STEMI patients, the management in their hospitalization should be optimized, including improvements in risk stratification, more widespread use of an invasive strategy, implementation of care delivery systems prioritising immediate revascularisation through PCI (or fibrinolysis), advances in antiplatelet agents and anticoagulants, and greater use of secondary prevention strategies such as lipid-lowering therapy.
This study aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.
Detailed description
This study is a prospective cohort study. It aims to standardized the management of STEMI patients and improve the prognosis of the STEMI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 5 Years
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is multi-center cohort study. Patients with acute ST elevation myocardial infarction undergo percutaneous coronary intervention within 12 hours of symptom onset at Ruijin Hospital, Minhang district Center Hospital, Yangpu district Center Hospital, Putuo district Center hospital,Jiading district Center Hospital, Fengxian district Center Hospital,and Shanghai Fifth people's Hospital, Shanghai, China are consecutively enrolled.
Key inclusion criteria (3 listed)
- ST elevation myocardial infarction
- Coronary angiography and percutaneous coronary intervention within 12 hours of symptom onset
- Capable and willing to provide informed conset and capable of completing study visits
Key exclusion criteria (4 listed)
- Cardiovascular shock at admission
- Severe physical disability
- Active malignant tumors
- Active autoimmune diseases
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
MACE
Time frame: 0-1 year
Major adverse cardiovascular events(MACE) in one year follow-up
Left Ventricular Function
Time frame: 1 month, 6month and 1 year
Left ventricular end diastolic volume(LVEDV),Left ventricular end systolic volume(LVESE),Left ventricular ejection fraction(LVEF) changes within one year follow-up
Coronary angiography
Time frame: 1 year
The pathological changes in culprit vessels in 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jul 2022.
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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.
Wei Wei Quan, M.D.,Ph.D. study chair
Ruijin Hospital
Tian Qi Zhu, M.D.,Ph.D. study chair
Ruijin Hospital
Xiao Xiang Yan, M.D.,Ph.D. study chair
Ruijin Hospital
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ST Elevation Myocardial Infarction, run by Ruijin Hospital at 7 sites 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 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 11 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites 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 Shuo Feng, M.D.,Ph.D. (+86 15921388296, fengshuorv@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MACE (time frame: 0-1 year). The study lists 3 primary outcomes in all. 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 11 Jul 2022.