ST-segment Elevation Myocardial Infarction (STEMI)NCT04996901
The Chinese STEMI PPCI Registry (CSPR)
An observational study of ST-segment Elevation Myocardial Infarction (STEMI), run by Renmin Hospital of Wuhan University at 1 site in China.
Trial summary
The purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- How many people
- 5,594 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2021to 5 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All patients with STEMI were treated by primary percutaneous coronary intervention at 7 large centers from central China.
Who may be able to join
- Age≥18
- ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction
- STEMI treated by pPCI
Who cannot join
- Patient with heart failure in admission
- STEMI with symptom-onset-to-balloon time>24h
- pPCI was not successful or only underwent coronary angiography
- Killip class ≥II in admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Chinese ST-Segment Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Registry
The purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.
Read the detailed description
The CSPR trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a ST-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.
- Being tested
- no intervention
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
no interventionOther
no intervention
| Study group | Role | What they receive |
|---|---|---|
| derivation cohort | Data from Renmin Hospital of Wuhan University, The First College of Clinical Medical Science, China Three Gorges University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital，and Wuhan Third Hospital will be used as a derivation cohort. Receives: Other: no intervention | |
| validation cohort | Data from The First Affiliated Hospital of Dalian Medical University and Jiangxi Provincial People's Hopital will be used as a derivation cohort. Receives: Other: no intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
in-hospital acute de novo heart failure
Killip class ≥II
Measured: in-hospital outcome, until discharge
cardiogenic shock
according to the universal definition
Measured: in-hospital outcome, until discharge
death
according to the universal definition
Measured: in-hospital outcome, until discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2021
- Study start22 May 2021
- Primary completion5 Dec 2021
- Study completion5 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 5,594 participants (actual)
Sponsor and investigators
- Lead sponsor
- Renmin Hospital of Wuhan University
- Sponsor type
- University, hospital or other
- Collaborators
- The First College of Clinical Medical Science, China Three Gorges University, The First Affiliated Hospital of Dalian Medical University, Jiangxi Provincial People's Hopital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital, Wuhan Third Hospital
- Responsible party
- Sponsor
- Investigators
- Liwei Cheng, Study director, Renmin Hospital of Wuhan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04996901
- Sponsor's protocol ID
- 958374
- Status last verified
- Dec 2021
- First submitted
- 27 Jul 2021
- Last updated
- 20 Dec 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Xu J, Luo D, Lei Y, Hu Z, Tian H, Chen X, Zhou W, Li M, Liu S, Jin X, Wang Y, Zhang B, Zhou Q, Chen J. Correlation between abnormal microvascular perfusion and quantitative flow ratio after primary PCI in patients with STEMI. Int J Cardiol. 2025 Mar 1;422:132949. doi: 10.1016/j.ijcard.2024.132949. Epub 2024 Dec 31.
PubMed 39746473Wang H, Yang Y, Zeng P, Huang R, Cai X, Shao L, Liu F, Lei Y, Li D, Fan Z, Yang J, Zhang J, Yang J. Association between Systemic Immune-Inflammation Index (SII) and New-Onset In-Hospital Heart Failure in Patients with STEMI after Primary PCI. Rev Cardiovasc Med. 2024 Oct 24;25(10):382. doi: 10.31083/j.rcm2510382. eCollection 2024 Oct.
PubMed 39484131Hu Z, Luo D, Zhou WJ, Xu CW, Chen XZ, Zhang BF, Jin X, Wang Y, Zhang J, Wu H, Liu FY, Lei YH, Li DS, Cai XY, Jiang H, Chen J. Association between admission blood pressure and spontaneous reperfusion and long-term prognosis in STEMI patients: an observational and multicenter study. BMC Cardiovasc Disord. 2024 Sep 18;24(1):500. doi: 10.1186/s12872-024-04168-4.
PubMed 39294617Luo D, Huang R, Wang X, Zhang J, Cai X, Liu F, Lei Y, Li D, Zhou W, Xu C, Huang B, Jiang H, Chen J. INTRA-AORTIC BALLOON PUMP REDUCES 30-DAY MORTALITY IN EARLY-STAGE CARDIOGENIC SHOCK COMPLICATING ACUTE MYOCARDIAL INFARCTION ACCORDING TO SCAI CLASSIFICATION. Shock. 2023 Sep 1;60(3):385-391. doi: 10.1097/SHK.0000000000002184. Epub 2023 Aug 4.
PubMed 37548623
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Chinese ST-Segment Elevation Myocardial Infarction Primary Percutaneous Coronary Intervention Registry
- ClinicalTrials.gov ID
- NCT04996901
- Acronym / sponsor ID
- 958374
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,594 participants (actual)
- Lead sponsor
- Renmin Hospital of Wuhan UniversityUniversity, hospital or other
- Collaborators
- The First College of Clinical Medical Science, China Three Gorges University, The First Affiliated Hospital of Dalian Medical University, Jiangxi Provincial People's Hopital, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital, Wuhan Third Hospital
- Study start
- 22 May 2021 (actual)
- Primary completion
- 5 Dec 2021 (actual)
- Study completion
- 5 Dec 2021 (actual)
- First posted
- 9 Aug 2021 (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 purpose of this study is to develop a risk score to predict the risks of in-hospital major adverse cardiac events in ST-segment elevation myocardial infarction patients treated by primary percutaneous coronary intervention.
Detailed description
The CSPR trial is an observational clinical trial to derive and validate a readily useable risk score to identify patients at high risk of in-hospital major adverse cardiac events in 5594 patients presenting with a ST-segment elevation myocardial infarction and treated by primary percutaneous coronary intervention.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| derivation cohort | – | Other: no interventionData from Renmin Hospital of Wuhan University, The First College of Clinical Medical Science, China Three Gorges University, The Central Hospital of Enshi Tujia And Miao Autonomous Prefecture, Xiangyang No.1 People's Hospital，and Wuhan Third Hospital will be used as a derivation cohort. |
| validation cohort | – | Other: no interventionData from The First Affiliated Hospital of Dalian Medical University and Jiangxi Provincial People's Hopital will be used as a derivation cohort. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with STEMI were treated by primary percutaneous coronary intervention at 7 large centers from central China.
Key inclusion criteria (3 listed)
- Age≥18
- ST-segment elevation myocardial infarction was defined according to the universal definition of myocardial infarction
- STEMI treated by pPCI
Key exclusion criteria (4 listed)
- Patient with heart failure in admission
- STEMI with symptom-onset-to-balloon time>24h
- pPCI was not successful or only underwent coronary angiography
- Killip class ≥II in admission
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 interventionno intervention | Other | derivation cohort, validation cohort |
Primary outcome
in-hospital acute de novo heart failure
Time frame: in-hospital outcome, until discharge
Killip class ≥II
cardiogenic shock
Time frame: in-hospital outcome, until discharge
according to the universal definition
death
Time frame: in-hospital outcome, until discharge
according to the universal definition
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2021.
- Derived from this study: PubMed 39746473Xu J, Luo D, Lei Y, Hu Z, Tian H, Chen X, Zhou W, Li M, Liu S, Jin X, Wang Y, Zhang B, Zhou Q, Chen J. Correlation between abnormal microvascular perfusion and quantitative flow ratio after primary PCI in patients with STEMI. Int J Cardiol. 2025 Mar 1;422:132949. doi: 10.1016/j.ijcard.2024.132949. Epub 2024 Dec 31.
- Derived from this study: PubMed 39484131Wang H, Yang Y, Zeng P, Huang R, Cai X, Shao L, Liu F, Lei Y, Li D, Fan Z, Yang J, Zhang J, Yang J. Association between Systemic Immune-Inflammation Index (SII) and New-Onset In-Hospital Heart Failure in Patients with STEMI after Primary PCI. Rev Cardiovasc Med. 2024 Oct 24;25(10):382. doi: 10.31083/j.rcm2510382. eCollection 2024 Oct.
- Derived from this study: PubMed 39294617Hu Z, Luo D, Zhou WJ, Xu CW, Chen XZ, Zhang BF, Jin X, Wang Y, Zhang J, Wu H, Liu FY, Lei YH, Li DS, Cai XY, Jiang H, Chen J. Association between admission blood pressure and spontaneous reperfusion and long-term prognosis in STEMI patients: an observational and multicenter study. BMC Cardiovasc Disord. 2024 Sep 18;24(1):500. doi: 10.1186/s12872-024-04168-4.
- Derived from this study: PubMed 37548623Luo D, Huang R, Wang X, Zhang J, Cai X, Liu F, Lei Y, Li D, Zhou W, Xu C, Huang B, Jiang H, Chen J. INTRA-AORTIC BALLOON PUMP REDUCES 30-DAY MORTALITY IN EARLY-STAGE CARDIOGENIC SHOCK COMPLICATING ACUTE MYOCARDIAL INFARCTION ACCORDING TO SCAI CLASSIFICATION. Shock. 2023 Sep 1;60(3):385-391. doi: 10.1097/SHK.0000000000002184. Epub 2023 Aug 4.
- Individual participant dataSharing planned: No
Related trials for ST-segment Elevation Myocardial Infarction (STEMI)
RecruitingObservational study
Breisgau PHENO-HEART MI
Myocardial Infarction, STEMI
Recruiting
Reducing Slow/No-Reflow With Prophylactic High-Dose Intracoronary Adenosine Protocol in ST-Elevation Myocardial Infarction The REFLOW AMI Trial
ST-Elevation Myocardial Infarction (STEMI)
Not yet recruitingPhase 2
Evaluating SGLT2 Inhibitors for the Reduction of No-Reflow Phenomenon in Patients Undergoing PCI
No Reflow Phenomenon, Reperfusion Injuries, Myocardial
Recruiting
Optimal Timing of Staged Complete Revascularization in STEMI With Multivessel Disease (OPTION-STEMI2)
Myocardial Infarction (MI)
RecruitingObservational study
Integrated Assessment of Immune-Inflammatory and Metabolic Biomarkers for Prediction of Coronary No-Reflow Following Primary PCI in STEMI Patients
Integrated Assessment, Immune-Inflammatory
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.
Liwei Cheng study director
Renmin Hospital of Wuhan 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 ST-segment Elevation Myocardial Infarction (STEMI), run by Renmin Hospital of Wuhan 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 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: finished, as of the sponsor's last update on 20 Dec 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
in-hospital acute de novo heart failure (time frame: in-hospital outcome, until discharge). 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?
On the ClinicalTrials.gov record for NCT04996901, which also lists 4 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 20 Dec 2021.