ST-segment Elevation Myocardial Infarction (STEMI)
Conditions
Keywords
ST-segment Elevation Myocardial Infarction (STEMI), Early Invasive Strategy
Brief summary
The primary objective of the trial is to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.
Detailed description
At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for ST-segment elevation myocardial infarction (STEMI) patients within 24h of symptom onset. In stable STEMI patients presenting 12 to 48 hours from symptom onset, BRAVE-2 Trial (n = 365) showed improved myocardial salvage and 4-year survival in patients treated with primary PCI compared with conservative treatment alone. However, data is scarce about the reperfusion strategy focusing on STEMI patients within 24-48h of symptom onset. Further investigations are warranted to explore the best timing of invasive strategy for STEMI patients within 24-48h of symptom onset. Given that no randomized clinical trial is designed especially for STEMI patients within 24-48h of symptom onset, and limited data is available to evaluate the efficacy of early invasive strategy for the special subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.
Interventions
PROCEDUREPrimary PCI
The patients assigned to early invasive strategy group will receive the primary PCI.
OTHEROptimal medical therapy with primary PCI not performed
The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.
Sponsors
Shanghai Zhongshan Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Age: 18 or over and less than 75 years old; 2. ECG: a) ≥2 mm ST-segment elevation in 2 contiguous precordial leads or ≥1 mm ST-segment elevation in 2 contiguous extremity leads; or b) new or presumable new left bundle branch block in the presence of typical symptoms; 3. Patents with STEMI with symptom onset between 24 and 48 hours before randomization; 4. Signed informed consent form prior to trial participation.
Exclusion criteria
1. Patents with STEMI with symptom onset \<24h or \>48h or uncertain time onset. 2. Prior administration of thrombolytic therapy or attempted PCI before randomization; 3. Presence of indications for primary PCI, such as persistent chest pain, cardiogenic shock, life-threatening arrhythmias or cardiac arrest, severe acute heart failure, and mechanical complications; 4. Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy; 5. Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin); 6. Presence of contraindications for CMR; 7. Congenital heart disease or severe valvular disease; 8. eGFR \<30 ml/min/1.73 m2; 9. History of malignant tumors; 10. Combined with other diseases and life expectancy ≤12 months; 11. Pregnancy; 12. Inclusion in another clinical trial; 13. Inability to provide informed consent or not available for follow-up judged by investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Myocardial infraction size assessed by cardiac magnetic resonance (CMR) | 7 days (from symptom onset) | Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke | 30 days | — |
| Microvascular obstruction (MVO) assessed by CMR | 7 days (from symptom onset) | Serial imaging sequence results from CMR. |
| Intramyocardial hemorrhage (IMH) assessed by CMR | 7 days (from symptom onset) | Serial imaging sequence results from CMR. |
| Left ventricular end-systolic volume (LVESV) assessed by CMR | 7 days (from symptom onset) | Imaging parameters from CMR. |
| Left ventricular ejection fraction (LVEF) assessed by CMR | 7 days (from symptom onset) | Imaging parameters from CMR. |
| Left ventricular end-diastolic volume (LVEDV) assessed by CMR | 7 days (from symptom onset) | Imaging parameters from CMR. |
| Area at risk (AAR) assessed by CMR | 7 days (from symptom onset) | Serial imaging sequence results from CMR. |
Countries
China
Contacts
Primary ContactXin Zhong, MD
Backup ContactWei Gao, MD
Outcome results
None listed