ClinicalTrials.gg
RecruitingNCT07833995TRACE-pPCIUpdated Sep 29, 2026

Trends and Risk Factors of Adverse Cardiovascular and Cerebrovascular Events After Primary PCI

An observational study in Acute Myocardial Infarction (AMI) and Percutaneous Coronary Intervention (PCI), sponsored by Shanghai Zhongshan Hospital. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-29.

Sponsored by Shanghai Zhongshan Hospital · Observational

From the registry’s dates

  • Started Sep 2026; still recruiting 1 month later.
Updated Sep 29, 2026Now RecruitingSite recruiting status changed+1 moreGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
8,000
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 194 studies in Myocardial Infarction with a site in China — 62 open to participants now, 71 under way, 7 of them phase 3. Myocardial Infarction · China.

Planned enrollment
17th of 88
8,000 · median 1,000
Started
2026
with 18 others
Observational
88 of 194
36 open now
Primary completion
2030-12
later than 63 of 70 live
Registered
193rd of 194
by date
Lead sponsor
9 of 194
Shanghai Zhongshan Hospital

Among the 194 studies in Myocardial Infarction with a site in China, this one is the 17th largest by planned enrollment of the 88 observational ones that give a count, is one of 19 that started in 2026, is one of 88 observational ones, reaches primary completion later than 63 of the 70 other live ones, and was the 193rd registered.

Myocardial Infarction

2,270 studies on the registry are indexed under Myocardial Infarction; 371 are open to participants now.

Browse Myocardial Infarction studies →

Open to participants now

62 of the 194 studies in Myocardial Infarction with a site in China are open now. Recruiting first, the newest first:

56 more — sign in →

All 62 open studies →

A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 255 Myocardial Infarction studies recruiting now, 172 (67%) set no upper age limit and 26 (10%) stop at 75 or younger; 16 take children under 18; 27 take healthy volunteers.

This study: 18 Years and older · all sexes · no healthy volunteers.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 194 studies in Myocardial Infarction with a site in China, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Acute Myocardial Infarction (AMI)
  • Percutaneous Coronary Intervention (PCI)
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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.
  • obtained, or criteria for waiver of informed consent.

Exclusion criteria

Exclusion Criteria:

  • Inability to tolerate PCI, or unsuccessful PCI.
  • Concomitant 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.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
8,000 participants (estimated)
Target follow-up
2 Years
Patient registry
Yes
Biospecimen retention
Samples without dna

Groups and cohorts

  • AMI patients undergoing primary PCI

    Acute myocardial infarction patients undergoing primary PCI

    Other: Collection of baseline characteristics

Interventions

  • OtherCollection of baseline characteristics

    Collection of baseline clinical characteristics, procedural details, laboratory results, and medication records

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Within 2 years after PCI

Secondary outcomes

  1. In-hospital all-cause death

    Death from any cause during hospitalization.

    Time frame: Perioperative/Periprocedural

  2. In-hospital impaired myocardial perfusion

    Post-PCI TIMI flow grade \<3 in the infarct-related artery.

    Time frame: At the end of the PCI procedure

  3. 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.

    Time frame: Perioperative/Periprocedural

  4. In-hospital acute heart failure

    New-onset or worsening acute heart failure requiring intravenous diuretics, vasoactive drugs, or mechanical support (e.g., IABP, ECMO).

    Time frame: Perioperative/Periprocedural

  5. In-hospital recurrent myocardial infarction

    Recurrent myocardial infarction during hospitalization.

    Time frame: Perioperative/Periprocedural

  6. In-hospital non-fatal ischemic stroke

    Non-fatal ischemic stroke during hospitalization.

    Time frame: Perioperative/Periprocedural

  7. All-cause death within 2 years after PCI

    Death from any cause within 2 years after PCI.

    Time frame: Within 2 years after PCI

  8. 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.

    Time frame: Within 2 years after PCI

  9. Recurrent myocardial infarction within 2 years after PCI

    Recurrent myocardial infarction within 2 years after PCI.

    Time frame: Within 2 years after PCI

  10. Ischemia-driven repeat revascularization within 2 years after PCI

    Repeat PCI or CABG driven by ischemia within 2 years after the index PCI.

    Time frame: Within 2 years after PCI

  11. Non-fatal ischemic stroke within 2 years after PCI

    Non-fatal ischemic stroke within 2 years after PCI.

    Time frame: Within 2 years after PCI

Other outcomes

  1. Bleeding events

    Bleeding events defined by the Bleeding Academic Research Consortium (BARC) within 2 years after PCI.

    Time frame: Within 2 years after PCI

  2. Cardiac function status during long-term follow-up

    To document changes in left ventricular ejection fraction (LVEF) during long-term follow-up. A normal LVEF is defined as \>53%, while an LVEF \<50% indicates impaired left ventricular systolic function.

    Time frame: Up to 2 years after PCI

  3. Malignancy as a Negative Control Outcome

    Incident malignancy or malignancy-related death within 2 years after PCI, used as a negative control outcome to assess potential detection bias, surveillance bias, or residual confounding.

    Time frame: Within 2 years after PCI

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No — The research involves some confidential content

No publications or documents are linked to this record.

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedDate before it movedWhere the date was before it movedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Sep 2026 (actual). Primary completion is estimated for Dec 2030, 51 months after the start.

Of 296 non-industry observational studies under Myocardial Infarction, half reached primary completion within 54 months of starting (the median), counting those still running; a quarter within 19 and three quarters within 140. This study's planned 51 months is close to that.

Counting every sponsor, half of 333 studies reached it within 48 months; a quarter within 17 and three quarters within 114.

Start moved once since we started tracking on Sep 25, 2026: Oct 2026 → Sep 2026, on Sep 29, 2026.

Earlier changes are on the record history on ClinicalTrials.gov ↗

How these figures are worked out, and which studies are left out of them.

Registered
Sep 16, 2026
First posted
Sep 22, 2026
StartActual
Sep 28, 2026was Oct 2026
Primary completionEst.
Dec 31, 2030
CompletionEst.
Mar 31, 2031
Last update
Sep 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Status
Not yet recruiting→Recruiting
changed Sep 29, 2026
Sites
Zhongshan Hospital, Fudan University is now Recruiting
Sep 29, 2026
Start date
Oct 1, 2026→Sep 28, 2026 (actual)
Sep 29, 2026
Show all 1 update
  1. Sep 29, 2026
    Not yet recruiting→Recruiting
    Zhongshan Hospital, Fudan University is now Recruiting
    Start date Oct 1, 2026→Sep 28, 2026 (now actual)

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT07833995
Responsible party
Chunfeng Dai (Principal Investigator, Shanghai Zhongshan Hospital) — Principal investigator
First posted
Sep 22, 2026
Start date
Sep 28, 2026
Primary completion
Dec 31, 2030 (estimated)
Completion
Mar 31, 2031 (estimated)
Last update
Sep 29, 2026

Study contacts

Chunfeng Dai, M.D.
Contact
dai.chunfeng@zs-hospital.sh.cn
86-021-64041990
Chunfeng Dai, M.D.
principal investigator · Fudan University

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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