Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Early Invasive Strategy | Experimental | Procedure: Primary PCI |
|
| Conservative Strategy | Active Comparator | Procedure: Optimal medical therapy with primary PCI not performed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Primary PCI | Procedure | The patients assigned to early invasive strategy group will receive the primary PCI. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Myocardial infraction size assessed by cardiac magnetic resonance (CMR) | Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification. | 7 days (from symptom onset) |
| Measure | Description | Time Frame |
|---|---|---|
| A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke | 30 days | |
| Microvascular obstruction (MVO) assessed by CMR | Serial imaging sequence results from CMR. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zhong, MD | Contact | +86 13585678706 | zhong.xin@zs-hospital.sh.cn | |
| Wei Gao, MD | Contact | +86 13661959824 | gao.wei1@zs-hospital.sh.cn |
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Zhongshan Hospital, Fudan University | Recruiting | Shanghai | Shanghai Municipality | 200032 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35525262 | Derived | Gao W, Zhong X, Ma Y, Huang D, Wang R, Zhao S, Yang S, Qian J, Ge J. A randomized multicenter trial to evaluate early invasive strategy for patients with acute ST-segment elevation myocardial infarction presenting 24-48 hours from symptom onset: Protocol of the RESCUE-MI study. Am Heart J. 2022 Sep;251:54-60. doi: 10.1016/j.ahj.2022.05.002. Epub 2022 May 5. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Optimal medical therapy with primary PCI not performed | Other | The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished. |
|
| 7 days (from symptom onset) |
| Intramyocardial hemorrhage (IMH) assessed by CMR | Serial imaging sequence results from CMR. | 7 days (from symptom onset) |
| Area at risk (AAR) assessed by CMR | Serial imaging sequence results from CMR. | 7 days (from symptom onset) |
| Left ventricular ejection fraction (LVEF) assessed by CMR | Imaging parameters from CMR. | 7 days (from symptom onset) |
| Left ventricular end-diastolic volume (LVEDV) assessed by CMR | Imaging parameters from CMR. | 7 days (from symptom onset) |
| Left ventricular end-systolic volume (LVESV) assessed by CMR | Imaging parameters from CMR. | 7 days (from symptom onset) |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |