Acute Myocardial Infarction (AMI)TRACE-pPCINCT07833995
Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI
An observational study of Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial summary
This single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI) from 2009 to 2028 will be included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction (AMI), Percutaneous Coronary Intervention (PCI)
- What is being tested?
- Collection of baseline characteristics
- How many people
- 8,000 participants
- Where
- 1 siteChina
- Study dates
- 28 Sep 2026to 31 Mar 2031
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: This study is an ambispective, registry-based cohort study that includes patients diagnosed with acute myocardial infarction who underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, from January 1, 2009, to December 31, 2028.
Who may be able to join
- Hospitalized at Zhongshan Hospital, Fudan University, with a diagnosis of acute myocardial infarction (AMI) according to the Universal Definition of Myocardial Infarction, between January 1, 2009, and December 31, 2028.
- Underwent primary percutaneous coronary intervention (PCI) during hospitalization (within 12 hours of symptom onset, or beyond 12 hours with persistent evidence of ischemia).
- Aged 18 years or older at the time of PCI.
- Informed consent obtained, or criteria for waiver of informed consent.
Who cannot join
- Inability to tolerate PCI, or unsuccessful PCI.
- Concomitant malignancy with an expected survival of less than 1 year.
- Pregnant or breastfeeding women.
- Missing data for key variables exceeding 30%, which would prevent valid analysis.
- Any other condition that, in the investigator's opinion, precludes participation.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai
Chunfeng Dai, M.D., 86-021-64041990, dai.chunfeng@zs-hospital.sh.cn
About this study
Official title: Trends and Risk Factors of Major Adverse Cardiovascular and Cerebrovascular Events After Primay Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Long-Term Follow-Up Study Based on Hospital Real-World Data
This single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI) from 2009 to 2028 will be included. Patients will be grouped into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. The study aims to describe 20-year trends in in-hospital events and major adverse cardiovascular and cerebrovascular events (MACCE) within 2 years after PCI and to identify independent risk factors. The primary outcome is MACCE within 2 years, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. Key secondary outcomes include in-hospital all-cause death, impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events. Data will come from electronic medical records and the cardiac catheterization database.
Read the detailed description
Background: Acute myocardial infarction (AMI) is a leading cause of cardiovascular death in China. Primary PCI improves outcomes, but patients remain at risk of in-hospital events and long-term major adverse cardiovascular and cerebrovascular events (MACCE). Long-term real-world evidence from China is limited.
Design: This single-center, ambispective cohort study will include about 8,000 AMI patients aged 18 years or older treated with primary PCI at Zhongshan Hospital, Fudan University, from 2009 to 2028. Patients will be divided into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. Follow-up will be 2 years after PCI or until an endpoint event, death, or loss to follow-up.
Objectives: To describe the incidence and 20-year trends of in-hospital events and 2-year MACCE, and to identify independent risk factors.
Outcomes: The primary outcome is 2-year MACCE, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. The key secondary outcome is in-hospital all-cause death. Other secondary outcomes include impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events.
Data and Analysis: Data will be obtained from electronic medical records and the cardiac catheterization database. Retrospective data will be collected for 2009-2026, with prospective enrollment for 2027-2028. Descriptive analysis, Kaplan-Meier method, log-rank test, Cox proportional hazards models, and logistic regression will be used. Subgroup and sensitivity analyses will be performed.
Ethics: Ethical approval will be obtained from the Ethics Committee of Zhongshan Hospital, Fudan University. Written informed consent will be obtained from prospective patients; verbal consent or a waiver will be requested for retrospective patients. No study-specific interventions are involved in this observational study.
- Being tested
- Collection of baseline characteristics
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collection of baseline characteristicsOther
Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records
| Study group | Role | What they receive |
|---|---|---|
| AMI patients undergoing primary PCI | Acute myocardial infarction patients undergoing primary PCI Receives: Other: Collection of baseline characteristics |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. The first occurrence of any component will be used for time-to-event analysis.
Measured: Within 2 years after PCI
Secondary outcomes (11)
In-hospital all-cause death
Death from any cause during hospitalization.
Measured: Perioperative/Periprocedural
In-hospital impaired myocardial perfusion
Post-PCI TIMI flow grade <3 in the infarct-related artery.
Measured: At the end of the PCI procedure
In-hospital malignant arrhythmia
New-onset ventricular tachycardia, ventricular fibrillation, or other malignant arrhythmias requiring drug therapy, electrical cardioversion/defibrillation, or temporary pacing during hospitalization.
Measured: Perioperative/Periprocedural
In-hospital acute heart failure
New-onset or worsening acute heart failure requiring intravenous diuretics, vasoactive drugs, or mechanical support (e.g., IABP, ECMO).
Measured: Perioperative/Periprocedural
In-hospital recurrent myocardial infarction
Recurrent myocardial infarction during hospitalization.
Measured: Perioperative/Periprocedural
In-hospital non-fatal ischemic stroke
Non-fatal ischemic stroke during hospitalization.
Measured: Perioperative/Periprocedural
All-cause death within 2 years after PCI
Death from any cause within 2 years after PCI.
Measured: Within 2 years after PCI
Cardiovascular death within 2 years after PCI
Death from cardiovascular causes within 2 years after PCI. Cardiovascular death includes death due to myocardial infarction, heart failure, arrhythmia, stroke, or other cardiovascular causes.
Measured: Within 2 years after PCI
Recurrent myocardial infarction within 2 years after PCI
Recurrent myocardial infarction within 2 years after PCI.
Measured: Within 2 years after PCI
Ischemia-driven repeat revascularization within 2 years after PCI
Repeat PCI or CABG driven by ischemia within 2 years after the index PCI.
Measured: Within 2 years after PCI
Non-fatal ischemic stroke within 2 years after PCI
Non-fatal ischemic stroke within 2 years after PCI.
Measured: Within 2 years after PCI
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2026
- Study start28 Sep 2026
- Primary completion31 Dec 2030 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Myocardial Infarction (AMI)Studies of the same condition, open and under way.
- More trials run by Shanghai Zhongshan 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
- Other
- Enrolment
- 8,000 participants (estimated)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chunfeng Dai, Shanghai Zhongshan Hospital
- Investigators
- Chunfeng Dai, M.D., Principal investigator, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07833995
- Sponsor's protocol ID
- B2026-593
- Acronym
- TRACE-pPCI
- Status last verified
- Sep 2026
- First submitted
- 16 Sep 2026
- Last updated
- 29 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The research involves some confidential content
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Trends and Risk Factors of Major Adverse Cardiovascular and Cerebrovascular Events After Primay Percutaneous Coronary Intervention in Acute Myocardial Infarction: A Long-Term Follow-Up Study Based on Hospital Real-World Data
- ClinicalTrials.gov ID
- NCT07833995
- Acronym / sponsor ID
- TRACE-pPCI / B2026-593
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 8,000 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 28 Sep 2026 (actual)
- Primary completion
- 31 Dec 2030 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 22 Sep 2026 (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 single-center, ambispective cohort study will use real-world data from Zhongshan Hospital, Fudan University. About 8,000 patients aged 18 years or older with acute myocardial infarction (AMI) who underwent primary percutaneous coronary intervention (PCI) from 2009 to 2028 will be included. Patients will be grouped into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. The study aims to describe 20-year trends in in-hospital events and major adverse cardiovascular and cerebrovascular events (MACCE) within 2 years after PCI and to identify independent risk factors. The primary outcome is MACCE within 2 years, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. Key secondary outcomes include in-hospital all-cause death, impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events. Data will come from electronic medical records and the cardiac catheterization database.
Detailed description
Background: Acute myocardial infarction (AMI) is a leading cause of cardiovascular death in China. Primary PCI improves outcomes, but patients remain at risk of in-hospital events and long-term major adverse cardiovascular and cerebrovascular events (MACCE). Long-term real-world evidence from China is limited.
Design: This single-center, ambispective cohort study will include about 8,000 AMI patients aged 18 years or older treated with primary PCI at Zhongshan Hospital, Fudan University, from 2009 to 2028. Patients will be divided into four periods: 2009-2013, 2014-2018, 2019-2023, and 2024-2028. Follow-up will be 2 years after PCI or until an endpoint event, death, or loss to follow-up.
Objectives: To describe the incidence and 20-year trends of in-hospital events and 2-year MACCE, and to identify independent risk factors.
Outcomes: The primary outcome is 2-year MACCE, defined as a composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. The key secondary outcome is in-hospital all-cause death. Other secondary outcomes include impaired myocardial perfusion, malignant arrhythmia, acute heart failure, recurrent myocardial infarction, non-fatal ischemic stroke, and bleeding events.
Data and Analysis: Data will be obtained from electronic medical records and the cardiac catheterization database. Retrospective data will be collected for 2009-2026, with prospective enrollment for 2027-2028. Descriptive analysis, Kaplan-Meier method, log-rank test, Cox proportional hazards models, and logistic regression will be used. Subgroup and sensitivity analyses will be performed.
Ethics: Ethical approval will be obtained from the Ethics Committee of Zhongshan Hospital, Fudan University. Written informed consent will be obtained from prospective patients; verbal consent or a waiver will be requested for retrospective patients. No study-specific interventions are involved in this observational study.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| AMI patients undergoing primary PCI | – | Other: Collection of baseline characteristicsAcute myocardial infarction patients undergoing primary PCI |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This study is an ambispective, registry-based cohort study that includes patients diagnosed with acute myocardial infarction who underwent primary percutaneous coronary intervention (PCI) at Zhongshan Hospital, Fudan University, from January 1, 2009, to December 31, 2028.
Key inclusion criteria (4 listed)
- Hospitalized at Zhongshan Hospital, Fudan University, with a diagnosis of acute myocardial infarction (AMI) according to the Universal Definition of Myocardial Infarction, between January 1, 2009, and December 31, 2028.
- Underwent primary percutaneous coronary intervention (PCI) during hospitalization (within 12 hours of symptom onset, or beyond 12 hours with persistent evidence of ischemia).
- Aged 18 years or older at the time of PCI.
- Informed consent obtained, or criteria for waiver of informed consent.
Key exclusion criteria (5 listed)
- Inability to tolerate PCI, or unsuccessful PCI.
- Concomitant malignancy with an expected survival of less than 1 year.
- Pregnant or breastfeeding women.
- Missing data for key variables exceeding 30%, which would prevent valid analysis.
- Any other condition that, in the investigator's opinion, precludes participation.
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 |
|---|---|---|
| Collection of baseline characteristicsCollection of baseline clinical characteristics, procedural details, laboratory results, and medication records | Other | AMI patients undergoing primary PCI |
Primary outcome
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE)
Time frame: Within 2 years after PCI
Composite of all-cause death, recurrent myocardial infarction, ischemia-driven repeat revascularization, and non-fatal ischemic stroke. The first occurrence of any component will be used for time-to-event analysis.
11 secondary outcomes
In-hospital all-cause death
Time frame: Perioperative/Periprocedural
In-hospital impaired myocardial perfusion
Time frame: At the end of the PCI procedure
In-hospital malignant arrhythmia
Time frame: Perioperative/Periprocedural
In-hospital acute heart failure
Time frame: Perioperative/Periprocedural
In-hospital recurrent myocardial infarction
Time frame: Perioperative/Periprocedural
In-hospital non-fatal ischemic stroke
Time frame: Perioperative/Periprocedural
All-cause death within 2 years after PCI
Time frame: Within 2 years after PCI
Cardiovascular death within 2 years after PCI
Time frame: Within 2 years after PCI
Recurrent myocardial infarction within 2 years after PCI
Time frame: Within 2 years after PCI
Ischemia-driven repeat revascularization within 2 years after PCI
Time frame: Within 2 years after PCI
Non-fatal ischemic stroke within 2 years after PCI
Time frame: Within 2 years after PCI
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Individual participant dataSharing planned: No. The research involves some confidential content
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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.
Chunfeng Dai, M.D. principal investigator
Fudan 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 Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI), run by Shanghai Zhongshan 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 5 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: looking for participants now, as of the sponsor's last update on 29 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chunfeng Dai, M.D. (86-021-64041990, dai.chunfeng@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Adverse Cardiovascular and Cerebrovascular Events (MACCE) (time frame: Within 2 years after PCI). 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 29 Sep 2026.