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

ST-segment Elevation Myocardial Infarction (STEMI) Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04962178
• Other study ID #: ZS AMI 24-48
• Status: Recruiting
• Phase: N/A
• Start date: September 9, 2021
• Est. completion date: June 2024

Study information

• Verified date: June 2022
• Source: Shanghai Zhongshan Hospital
• Contact: Xin Zhong, MD
• Phone: +86 13585678706
• Email: zhong.xin[@]zs-hospital.sh.cn
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 366
• Est. completion date: June 2024
• Est. primary completion date: December 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• ST-segment Elevation Myocardial Infarction (STEMI)

Intervention

Procedure:
• Primary PCI
The patients assigned to early invasive strategy group will receive the primary PCI.

Other:
• Optimal medical therapy with primary PCI not performed
The patients assigned to conservative strategy group will receive optimal medical therapy before primary endpoint accomplished.

Locations

Country	Name	City	State
China	Zhongshan Hospital, Fudan University	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Zhongshan Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	A composite of cardiac death, recurrent myocardial infarction, ischaemia-driven target vessel revascularization, and stoke		30 days
Secondary	Microvascular obstruction (MVO) assessed by CMR	Serial imaging sequence results from CMR.	7 days (from symptom onset)
Secondary	Intramyocardial hemorrhage (IMH) assessed by CMR	Serial imaging sequence results from CMR.	7 days (from symptom onset)
Secondary	Area at risk (AAR) assessed by CMR	Serial imaging sequence results from CMR.	7 days (from symptom onset)
Secondary	Left ventricular ejection fraction (LVEF) assessed by CMR	Imaging parameters from CMR.	7 days (from symptom onset)
Secondary	Left ventricular end-diastolic volume (LVEDV) assessed by CMR	Imaging parameters from CMR.	7 days (from symptom onset)
Secondary	Left ventricular end-systolic volume (LVESV) assessed by CMR	Imaging parameters from CMR.	7 days (from symptom onset)