Clinical trial NCT04962178: Evaluate Early Invasive Strategy for Patients With STEMI Presenting 24-48 Hours From Symptom Onset
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
Keywords: ST-segment Elevation Myocardial Infarction (STEMI)
Early Invasive Strategy
Lead sponsor: Shanghai Zhongshan Hospital
Sponsor class: OTHER
First posted: 2021-07-14
Enrollment: 366
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
timeFrame: 7 days (from symptom onset)
Secondary outcomes:
measure: A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke
timeFrame: 30 days
measure: Microvascular obstruction (MVO) assessed by CMR
timeFrame: 7 days (from symptom onset)
measure: Intramyocardial hemorrhage (IMH) assessed by CMR
timeFrame: 7 days (from symptom onset)
measure: Area at risk (AAR) assessed by CMR
timeFrame: 7 days (from symptom onset)
measure: Left ventricular ejection fraction (LVEF) assessed by CMR
timeFrame: 7 days (from symptom onset)
measure: Left ventricular end-diastolic volume (LVEDV) assessed by CMR
timeFrame: 7 days (from symptom onset)
measure: Left ventricular end-systolic volume (LVESV) assessed by CMR
timeFrame: 7 days (from symptom onset)
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Zhongshan Hospital, Fudan University
state: Shanghai
Study officials:
References:
citation: 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.