CClinicalTrials.gg
Sign In
Status unknownNCT04962178Updated Jun 24, 2022

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

An interventional study of Primary PCI and Optimal medical therapy with primary PCI not performed in ST-segment Elevation Myocardial Infarction (STEMI), sponsored by Shanghai Zhongshan Hospital. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-06-24.

Sponsored by Shanghai Zhongshan Hospital · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jun 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
366
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • ST-segment Elevation Myocardial Infarction (STEMI)

Keywords

  • ST-segment Elevation Myocardial Infarction (STEMI)
  • Early Invasive Strategy
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's planned enrollment of 366 is above the median of 148 across 1,595 interventional studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Shanghai Zhongshan Hospital is the lead sponsor of 638 studies on the registry; 285 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
366 participants (estimated)

Study arms

  • Experimental
    Early Invasive Strategy

    Procedure: Primary PCI

    Procedure: Primary PCI

  • Active comparator
    Conservative Strategy

    Procedure: Optimal medical therapy with primary PCI not performed.

    Other: Optimal medical therapy with primary PCI not performed

Interventions

  • ProcedurePrimary PCI

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

  • OtherOptimal medical therapy with primary PCI not performed

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

06

What researchers measure

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.

    Time frame: 7 days (from symptom onset)

Secondary outcomes

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

    Time frame: 30 days

  2. Microvascular obstruction (MVO) assessed by CMR

    Serial imaging sequence results from CMR.

    Time frame: 7 days (from symptom onset)

  3. Intramyocardial hemorrhage (IMH) assessed by CMR

    Serial imaging sequence results from CMR.

    Time frame: 7 days (from symptom onset)

  4. Area at risk (AAR) assessed by CMR

    Serial imaging sequence results from CMR.

    Time frame: 7 days (from symptom onset)

  5. Left ventricular ejection fraction (LVEF) assessed by CMR

    Imaging parameters from CMR.

    Time frame: 7 days (from symptom onset)

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

    Imaging parameters from CMR.

    Time frame: 7 days (from symptom onset)

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

    Imaging parameters from CMR.

    Time frame: 7 days (from symptom onset)

07

Study locations

1 of 1 sites recruiting
  • Zhongshan Hospital, Fudan University
    Shanghai, Shanghai 200032, China
    Recruiting
08

References and documents

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. PubMed 35525262 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 24, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04962178
Lead sponsor
Shanghai Zhongshan Hospital
Responsible party
Sponsor
First posted
Jul 14, 2021
Start date
Sep 9, 2021
Primary completion
Dec 2023 (estimated)
Completion
Jun 2024 (estimated)
Last update
Jun 24, 2022

Study contacts

Xin Zhong, MD
Contact
zhong.xin@zs-hospital.sh.cn
+86 13585678706
Wei Gao, MD
Contact
gao.wei1@zs-hospital.sh.cn
+86 13661959824

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies in this condition

Myocardial Infarction→

Other studies from this sponsor

Shanghai Zhongshan Hospital

Start the discussion