ST-segment Elevation Myocardial Infarction (STEMI)NCT04962178
Evaluate Early Invasive Strategy for Patients With STEMI Presenting 24-48 Hours From Symptom Onset
A study testing Primary PCI and Optimal medical therapy with primary PCI not performed in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Shanghai Zhongshan Hospital at 1 site in China.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- ST-segment Elevation Myocardial Infarction (STEMI)
- What is being tested?
- Primary PCI and Optimal medical therapy with primary PCI not performed
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 366 participants
- Where
- 1 siteChina
- Study dates
- 9 Sep 2021to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Show all 13Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Zhongshan Hospital, Fudan University
Shanghai, Shanghai Municipality, 200032
Xin Zhong, M.D., +86 18930933927, zhong.xin@zs-hospital.sh.cn
About this study
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
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.
- Being tested
- Primary PCI, Optimal medical therapy with primary PCI not performed
- Keywords
- ST-segment Elevation Myocardial Infarction (STEMI), Early Invasive Strategy
- Medical subject headings
- ST Elevation Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary PCIProcedure or surgery
The patients assigned to early invasive strategy group will receive the primary PCI.
Optimal medical therapy with primary PCI not performedOther
The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.
| Study group | Role | What they receive |
|---|---|---|
| Early Invasive Strategy | Experimental | Procedure: Primary PCI Receives: Procedure: Primary PCI |
| Conservative Strategy | Active comparator | Procedure: Optimal medical therapy with primary PCI not performed. Receives: Other: Optimal medical therapy with primary PCI not performed |
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.
Measured: 7 days (from symptom onset)
Secondary outcomes (7)
A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke
Measured: 30 days
Microvascular obstruction (MVO) assessed by CMR
Serial imaging sequence results from CMR.
Measured: 7 days (from symptom onset)
Intramyocardial hemorrhage (IMH) assessed by CMR
Serial imaging sequence results from CMR.
Measured: 7 days (from symptom onset)
Area at risk (AAR) assessed by CMR
Serial imaging sequence results from CMR.
Measured: 7 days (from symptom onset)
Left ventricular ejection fraction (LVEF) assessed by CMR
Imaging parameters from CMR.
Measured: 7 days (from symptom onset)
Left ventricular end-diastolic volume (LVEDV) assessed by CMR
Imaging parameters from CMR.
Measured: 7 days (from symptom onset)
Left ventricular end-systolic volume (LVESV) assessed by CMR
Imaging parameters from CMR.
Measured: 7 days (from symptom onset)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2021
- Study start9 Sep 2021
- Primary completionDec 2023 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ST-segment Elevation Myocardial Infarction (STEMI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 366 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Zhongshan Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04962178
- Sponsor's protocol ID
- ZS AMI 24-48
- Status last verified
- Jun 2022
- First submitted
- 23 Jun 2021
- Last updated
- 24 Jun 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04962178
- Acronym / sponsor ID
- ZS AMI 24-48
- Keywords
- ST-segment Elevation Myocardial Infarction (STEMI), Early Invasive Strategy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 366 participants (estimated)
- Lead sponsor
- Shanghai Zhongshan HospitalUniversity, hospital or other
- Study start
- 9 Sep 2021 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 14 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Early Invasive Strategy | Experimental | Procedure: Primary PCIProcedure: Primary PCI |
| Conservative Strategy | Active comparator | Other: Optimal medical therapy with primary PCI not performedProcedure: Optimal medical therapy with primary PCI not performed. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (13 listed)
- 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);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary PCIThe patients assigned to early invasive strategy group will receive the primary PCI. | Procedure or surgery | Early Invasive Strategy |
| Optimal medical therapy with primary PCI not performedThe patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished. | Other | Conservative Strategy |
Primary outcome
Myocardial infraction size assessed by cardiac magnetic resonance (CMR)
Time frame: 7 days (from symptom onset)
Late gadolinium enhancement (LGE) by CMR is performed for myocardial infarction size quantification.
7 secondary outcomes
A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke
Time frame: 30 days
Microvascular obstruction (MVO) assessed by CMR
Time frame: 7 days (from symptom onset)
Intramyocardial hemorrhage (IMH) assessed by CMR
Time frame: 7 days (from symptom onset)
Area at risk (AAR) assessed by CMR
Time frame: 7 days (from symptom onset)
Left ventricular ejection fraction (LVEF) assessed by CMR
Time frame: 7 days (from symptom onset)
Left ventricular end-diastolic volume (LVEDV) assessed by CMR
Time frame: 7 days (from symptom onset)
Left ventricular end-systolic volume (LVESV) assessed by CMR
Time frame: 7 days (from symptom onset)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2022.
- Derived from this study: PubMed 35525262Gao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Primary PCI and Optimal medical therapy with primary PCI not performed in people with ST-segment Elevation Myocardial Infarction (STEMI), run by Shanghai Zhongshan Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xin Zhong, MD (+86 13585678706, zhong.xin@zs-hospital.sh.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Myocardial infraction size assessed by cardiac magnetic resonance (CMR) (time frame: 7 days (from symptom onset)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04962178, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jun 2022.