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

NCT04962178 | Unknown DMC

• 1 other identifier: ZS AMI 24-48
• Study Type: interventional
• Target: 366
• Locations: 1 country
• Sites: 1

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.

Conditions

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

ST-segment Elevation Myocardial Infarction (STEMI); Early Invasive Strategy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke

  30 days

• Microvascular obstruction (MVO) assessed by CMR

  7 days (from symptom onset)

• Intramyocardial hemorrhage (IMH) 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)

Study Arms (2)

Early Invasive Strategy

EXPERIMENTAL

Procedure: Primary PCI

Procedure: Primary PCI

Conservative Strategy

ACTIVE COMPARATOR

Procedure: Optimal medical therapy with primary PCI not performed.

Other: Optimal medical therapy with primary PCI not performed

Interventions

Primary PCI PROCEDURE

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

Early Invasive Strategy

Optimal medical therapy with primary PCI not performed OTHER

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

Conservative Strategy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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;
• Pregnancy;
• Inability to provide informed consent or not available for follow-up judged by investigator.

Sponsors & Collaborators

• Shanghai Zhongshan Hospital: lead

Study Sites (1)

Zhongshan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

Related Publications (1)

• 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.

  PMID: 35525262 DERIVED

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Central Study Contacts

Xin Zhong, MD

CONTACT

+86 13585678706; zhong.xin@zs-hospital.sh.cn

Wei Gao, MD

CONTACT

+86 13661959824; gao.wei1@zs-hospital.sh.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 23, 2021
• First Posted: July 14, 2021
• Study Start: September 9, 2021
• Primary Completion: December 1, 2023
• Study Completion: June 1, 2024
• Last Updated: June 24, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)