The primary objective of the trial is to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
366
The patients assigned to early invasive strategy group will receive the primary PCI.
The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, China
RECRUITINGMyocardial infraction size assessed by cardiac magnetic resonance (CMR)
Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.
Time frame: 7 days (from symptom onset)
A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke
Time frame: 30 days
Microvascular obstruction (MVO) assessed by CMR
Serial imaging sequence results from CMR.
Time frame: 7 days (from symptom onset)
Intramyocardial hemorrhage (IMH) assessed by CMR
Serial imaging sequence results from CMR.
Time frame: 7 days (from symptom onset)
Area at risk (AAR) assessed by CMR
Serial imaging sequence results from CMR.
Time frame: 7 days (from symptom onset)
Left ventricular ejection fraction (LVEF) assessed by CMR
Imaging parameters from CMR.
Time frame: 7 days (from symptom onset)
Left ventricular end-diastolic volume (LVEDV) assessed by CMR
Imaging parameters from CMR.
Time frame: 7 days (from symptom onset)
Left ventricular end-systolic volume (LVESV) assessed by CMR
Imaging parameters from CMR.
Time frame: 7 days (from symptom onset)
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