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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- ST-segment Elevation Myocardial Infarction (STEMI)
- Sponsor
- Shanghai Zhongshan Hospital
- Enrollment
- 366
- Locations
- 1
- Primary Endpoint
- Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
- Last Updated
- 3 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: 18 or over and less than 75 years old;
- •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;
- •Patents with STEMI with symptom onset between 24 and 48 hours before randomization;
- •Signed informed consent form prior to trial participation.
Exclusion Criteria
- •Patents with STEMI with symptom onset \<24h or \>48h or uncertain time onset.
- •Prior administration of thrombolytic therapy or attempted PCI before randomization;
- •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;
- •Coagulopathy, active peptic ulcer, history of cerebral or subarachnoid hemorrhage, stroke within 6 months, other contraindications for antiplatelet or anticoagulant therapy;
- •Known intolerance to antiplatelet (e.g. aspirin, clopidogrel, ticagrelor) and anticoagulant therapy (e.g. heparin, bivalirudin);
- •Presence of contraindications for CMR;
- •Congenital heart disease or severe valvular disease;
- •eGFR \<30 ml/min/1.73 m2;
- •History of malignant tumors;
- •Combined with other diseases and life expectancy ≤12 months;
Outcomes
Primary Outcomes
Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
Time Frame: 7 days (from symptom onset)
Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.
Secondary Outcomes
- A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke(30 days)
- Intramyocardial hemorrhage (IMH) assessed by CMR(7 days (from symptom onset))
- Left ventricular end-systolic volume (LVESV) assessed by CMR(7 days (from symptom onset))
- Area at risk (AAR) assessed by CMR(7 days (from symptom onset))
- Left ventricular ejection fraction (LVEF) assessed by CMR(7 days (from symptom onset))
- Left ventricular end-diastolic volume (LVEDV) assessed by CMR(7 days (from symptom onset))
- Microvascular obstruction (MVO) assessed by CMR(7 days (from symptom onset))