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
Not provided
The primary objective of the trial is to compare the efficacy of early with deferred invasive strategy for patients with ST-segment elevation myocardial infarction (STEMI) within 24-48h of symptom onset.
At present, timely primary percutaneous coronary intervention (PCI) is the preferred strategy for 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.
To our knowledge, due to the long onset time and insufficient antiplatelet/anticoagulant treatment, infarct-related artery in STEMI patients beyond 24h of symptom onset frequently suffer from severer thrombus burden. In this situation, the risk of no-reflow in primary PCI is high. Meanwhile, myocardial coagulative necrosis would be fully developed during 24-72h from symptom onset, the risk of perioperative cardiac rupture may also rise. These bring some doubts about the benefits of early invasive strategy for 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 compare early with deferred invasive strategy for the subgroup of STEMI patients, investigators plan to perform a controlled, randomized trial to compare the efficacy of early with deferred invasive strategy for STEMI patients within 24-48h of symptom onset.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Deferred invasive strategy | Experimental |
| |
| Early invasive strategy | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Deferred invasive strategy | Procedure | PCI on 7 to 10 days after symptom onset |
|
| Measure | Description | Time Frame |
|---|---|---|
| A composite of death from any cause, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, or hospitalization due to NYHA class IV heart failure | 4 years |
| Measure | Description | Time Frame |
|---|---|---|
| No-reflow in infarct-related artery | The definition of no-reflow was Thrombolysis In Myocardial Infarction (TIMI) flow grade ≤ 2 on the final angiogram in a coronary angiographic analysis. | Immediately after PCI |
| Major adverse cardiac events (defined as a composite of cardiac death, recurrent myocardial infarction, or ischaemia-driven target vessel revascularization) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Xin Zhong, M.D. | Contact | +86 13585678706 | zhong.xin@zs-hospital.sh.cn | |
| Wei Gao, M.D. | Contact | +86 13661959824 | gao.wei1@zs-hospital.sh.cn |
| Name | Affiliation | Role |
|---|---|---|
| Junbo Ge, M.D. | Shanghai Institute of Cardiovascular Diseases, Zhongshan Hospital, Fudan University | Principal Investigator |
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
| Early invasive strategy | Procedure | Primary PCI |
|
| 30 days |
| Stroke | The diagnosis of stroke required confirmation by computed tomography or magnetic resonance imaging of the head in the presence of a new onset focal or global neurological deficit lasting more than 24 hours. | 30 days |
| Death from any cause | 4 years |
| Recurrent myocardial infarction | 4 years |
| Ischaemia-driven target vessel revascularization | 4 years |
| Hospitalization due to NYHA class IV heart failure | 4 years |
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |