Outcomes after primary PCI for heart attack patients at Zhongshan Hospital
A Clinical Cohort Registry Study on Primary PCI for Acute Myocardial Infarction at Zhongshan Hospital
This project will follow people who had a heart attack and received primary PCI at Zhongshan Hospital to see if their clinical and procedural details relate to in-hospital and two-year outcomes.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 6000 (estimated) |
| Sex | All |
| Sponsor | Shanghai Zhongshan Hospital Academic / other |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07400601 on ClinicalTrials.gov |
What this trial studies
This is a prospective, registry-based cohort enrolling consecutive patients with acute myocardial infarction who underwent primary PCI at Zhongshan Hospital between January 2009 and December 2028. Investigators will systematically collect baseline demographics, clinical history, laboratory results, medication use, procedural details, and intraoperative measures of microcirculatory perfusion. Predefined endpoints include in-hospital events (MACCE, bleeding, malignant arrhythmias, acute heart failure, cardiogenic shock, and cerebrovascular events) and long-term outcomes up to two years (all-cause death, recurrent MI, ischemia-driven repeat revascularization, heart failure readmission, and changes in cardiac function). The registry also records malignant tumors as a falsification endpoint to help detect potential confounding.
Who should consider this trial
Good fit: Adults diagnosed with acute myocardial infarction who underwent primary PCI at Zhongshan Hospital, have troponin T elevation and at least one ischemic criterion, and can give informed consent are eligible.
Not a fit: Patients who did not complete emergent PCI, who received thrombolysis before PCI, or who have type 2 or type 3 myocardial infarction are unlikely to benefit from the registry findings.
Why it matters
Potential benefit: If successful, the registry could help clinicians identify which factors predict better or worse recovery after primary PCI and guide improvements in care for future heart attack patients.
How similar studies have performed: Large multicenter and single-center PCI registries have previously informed treatment and risk prediction after AMI, so this work builds on established registry methods while adding long-term, locally specific data.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Elevated or decreasing levels of cardiac troponin T, with at least one measurement exceeding 0.014 ng/mL; * Presence of at least one of the following: symptoms of myocardial ischemia; newly onset ischemic changes on ECG; pathological Q wave; imaging evidence of new loss of viable myocardium or regional wall motion abnormalities consistent with ischemia; coronary angiography confirming the presence of a thrombus; * Undergoing primary PCI; * Voluntary informed consent to participate in the study. Exclusion Criteria: * Inability to complete emergent PCI (e.g., due to intraoperative complications or inability to tolerate the procedure). * Prior administration of thrombolytic therapy before PCI. * Diagnosis of type 2 or type 3 myocardial infarction.
Where this trial is running
Shanghai
- Shanghai Zhongshan Hospital — Shanghai, China (Recruiting)
Study contacts
- Principal investigator: Chunfeng Dai, M.D. — Fudan University
- Study coordinator: Chunfeng Dai, M.D.
- Email: dai.chunfeng@zs-hospital.sh.cn
- Phone: 86-021-64041990
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.