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

Primary Purpose

ST-segment Elevation Myocardial Infarction (STEMI)

Status

Recruiting

Phase

Not Applicable

Locations

China

Study Type

Interventional

Intervention

Primary PCI

Optimal medical therapy with primary PCI not performed

About this trial

This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI) focused on measuring ST-segment Elevation Myocardial Infarction (STEMI), Early Invasive Strategy

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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;
Pregnancy;
Inclusion in another clinical trial;
Inability to provide informed consent or not available for follow-up judged by investigator.

Sites / Locations

Zhongshan Hospital, Fudan UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Early Invasive Strategy

Conservative Strategy

Arm Description

Procedure: Primary PCI

Procedure: Optimal medical therapy with primary PCI not performed.

Outcomes

Primary Outcome Measures

Myocardial infraction size assessed by cardiac magnetic resonance (CMR)

Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.

Secondary Outcome Measures

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

Microvascular obstruction (MVO) assessed by CMR

Serial imaging sequence results from CMR.

Intramyocardial hemorrhage (IMH) assessed by CMR

Serial imaging sequence results from CMR.

Area at risk (AAR) assessed by CMR

Serial imaging sequence results from CMR.

Left ventricular ejection fraction (LVEF) assessed by CMR

Imaging parameters from CMR.

Left ventricular end-diastolic volume (LVEDV) assessed by CMR

Imaging parameters from CMR.

Left ventricular end-systolic volume (LVESV) assessed by CMR

Imaging parameters from CMR.

Full Information

NCT ID

NCT04962178

First Posted

June 23, 2021

Last Updated

June 23, 2022

Sponsor

Shanghai Zhongshan Hospital

1. Study Identification

Unique Protocol Identification Number

NCT04962178

Brief Title

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

2. Study Status

Record Verification Date

June 2022

Overall Recruitment Status

Recruiting

Study Start Date

September 9, 2021 (Actual)

Primary Completion Date

December 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Shanghai Zhongshan Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

366 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Early Invasive Strategy

Arm Type

Experimental

Arm Description

Procedure: Primary PCI

Arm Title

Conservative Strategy

Arm Type

Active Comparator

Arm Description

Procedure: Optimal medical therapy with primary PCI not performed.

Intervention Type

Procedure

Intervention Name(s)

Primary PCI

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Optimal medical therapy with primary PCI not performed

Intervention Description

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

Primary Outcome Measure Information:

Title

Myocardial infraction size assessed by cardiac magnetic resonance (CMR)

Description

Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.

Time Frame

7 days (from symptom onset)

Secondary Outcome Measure Information:

Title

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

Time Frame

30 days

Title

Microvascular obstruction (MVO) assessed by CMR

Description

Serial imaging sequence results from CMR.

Time Frame

7 days (from symptom onset)

Title

Intramyocardial hemorrhage (IMH) assessed by CMR

Description

Serial imaging sequence results from CMR.

Time Frame

7 days (from symptom onset)

Title

Area at risk (AAR) assessed by CMR

Description

Serial imaging sequence results from CMR.

Time Frame

7 days (from symptom onset)

Title

Left ventricular ejection fraction (LVEF) assessed by CMR

Description

Imaging parameters from CMR.

Time Frame

7 days (from symptom onset)

Title

Left ventricular end-diastolic volume (LVEDV) assessed by CMR

Description

Imaging parameters from CMR.

Time Frame

7 days (from symptom onset)

Title

Left ventricular end-systolic volume (LVESV) assessed by CMR

Description

Imaging parameters from CMR.

Time Frame

7 days (from symptom onset)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

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; Pregnancy; Inclusion in another clinical trial; Inability to provide informed consent or not available for follow-up judged by investigator.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Xin Zhong, MD

Phone

+86 13585678706

zhong.xin@zs-hospital.sh.cn

First Name & Middle Initial & Last Name or Official Title & Degree

Wei Gao, MD

Phone

+86 13661959824

gao.wei1@zs-hospital.sh.cn

Facility Information:

Facility Name

Zhongshan Hospital, Fudan University

City

Shanghai

State/Province

Shanghai

ZIP/Postal Code

200032

Country

China

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Xin Zhong, M.D.

Phone

+86 18930933927

zhong.xin@zs-hospital.sh.cn

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35525262

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.

Results Reference

derived

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