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

NCT ID: NCT04962178

Last Updated: 2022-06-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 366 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-09
• Study Completion Date: 2024-06-30

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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Early Invasive Strategy

Procedure: Primary PCI

Group Type: EXPERIMENTAL

Primary PCI

Intervention Type: PROCEDURE

The patients assigned to early invasive strategy group will receive the primary PCI.

Conservative Strategy

Procedure: Optimal medical therapy with primary PCI not performed.

Group Type: ACTIVE_COMPARATOR

Optimal medical therapy with primary PCI not performed

Intervention Type: OTHER

The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.

Interventions

Primary PCI

The patients assigned to early invasive strategy group will receive the primary PCI.

Intervention Type: PROCEDURE

Optimal medical therapy with primary PCI not performed

The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.

Intervention Type: OTHER

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Zhongshan Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Xin Zhong, MD

Role: CONTACT

zhong.xin@zs-hospital.sh.cn

+86 13585678706

Wei Gao, MD

Role: CONTACT

gao.wei1@zs-hospital.sh.cn

+86 13661959824

Facility Contacts

Xin Zhong, M.D.

Role: primary

zhong.xin@zs-hospital.sh.cn

+86 18930933927

References

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.

Reference Type: DERIVED

PMID: 35525262 (View on PubMed)

Other Identifiers

ZS AMI 24-48

Identifier Type: -

Identifier Source: org_study_id