Evaluate Early Invasive Strategy for Patients With STEMI Presenting 24-48 Hours From Symptom Onset

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

The primary objective of the trial is to evaluate the efficacy of early invasive strategy for STEMI patients within 24-48h of symptom onset.

Study Overview

• Status: Recruiting
• Conditions: ST-segment Elevation Myocardial Infarction (STEMI)
• Intervention / Treatment: Procedure: Primary PCI; Other: Optimal medical therapy with primary PCI not performed

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.

• Study Type: Interventional
• Enrollment (Anticipated): 366
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Xin Zhong, MD; Phone Number: +86 13585678706; Email: zhong.xin@zs-hospital.sh.cn
• Study Contact Backup: Name: Wei Gao, MD; Phone Number: +86 13661959824; Email: gao.wei1@zs-hospital.sh.cn

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200032
      • Recruiting
      • Zhongshan Hospital, Fudan University
      • Contact: Xin Zhong, M.D.; Phone Number: +86 18930933927; Email: zhong.xin@zs-hospital.sh.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Early Invasive Strategy; Procedure: Primary PCI	Procedure: Primary PCI; The patients assigned to early invasive strategy group will receive the primary PCI.
ACTIVE_COMPARATOR: Conservative Strategy; Procedure: Optimal medical therapy with primary PCI not performed.	Other: Optimal medical therapy with primary PCI not performed; The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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)

Secondary Outcome Measures

Outcome Measure	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.	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)

Collaborators and Investigators

• Sponsor: Shanghai Zhongshan Hospital

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 9, 2021
• Primary Completion (ANTICIPATED): December 1, 2023
• Study Completion (ANTICIPATED): June 1, 2024

Study Registration Dates

• First Submitted: June 23, 2021
• First Submitted That Met QC Criteria: July 10, 2021
• First Posted (ACTUAL): July 14, 2021

Study Record Updates

• Last Update Posted (ACTUAL): June 24, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: ST-segment Elevation Myocardial Infarction (STEMI); Early Invasive Strategy
• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Myocardial Infarction; Infarction; ST Elevation Myocardial Infarction
• Other Study ID Numbers: ZS AMI 24-48

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No