Thrombolysis in STEMI Patients Compared With pPCI on Recanalization Time in the Context of the COVID-19 Outbreak.

Not Applicable

• Conditions: STEMI - ST Elevation Myocardial Infarction
• Interventions: Procedure: percutaneous coronary stenting; Drug: Thrombolytic

• Registration Number: NCT05354128
• Lead Sponsor: Ya-Wei Xu

Brief Summary

During the outbreak of COVID-19, for patients with acute ST-segment elevation myocardial infarction with unclear infection, the time of primary PCI is uncertain, and it is often expected to exceed 90 minutes or even 120 minutes. In indicated patients, intravenous thrombolysis has significantly improved the recanalization time of criminal vessels.

Detailed Description

During the outbreak of COVID-19, for patients with acute ST-segment elevation myocardial infarction with unclear infection, the time of primary PCI is uncertain, and it is often expected to exceed 90 minutes or even 120 minutes. In indicated patients, intravenous thrombolysis has significantly improved the recanalization time of criminal vessels. The purpose of this study was to compare the time from first medical contact to patency and safety (specifically symptom improvement, ECG ST segment) between intravenous thrombolysis and concurrent patients with possible primary PCI in a prospective, multicenter, non-randomized controlled manner. Significant fall, angiographic examination showed criminal blood vessel TIMI blood flow grade 2-3)

Study Timeline

• Study Start: 2022-04-01
• Study First Submitted: 2022-04-27
• Study First Submitted QC: 2022-04-27
• Study First Posted: 2022-04-29
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-20
• Last Update Posted: 2022-05-26
• Primary Completion: 2022-11-30
• Study Completion: 2023-04-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 120

Inclusion Criteria

• ECG confirms acute ST-segment elevation myocardial infarction；The estimated time from FMC to recanalization is more than 120 minutes；

Exclusion Criteria

• Intracranial hemorrhage or stroke within the past 6 months; central nervous system injury, tumor or arteriovenous malformation; bleeding disease with known cause; suspected aortic dissection; non-compressible puncture surgery within 24 hours, etc.; 1 week of pregnancy or postpartum; uncontrolled hypertension; advanced liver disease; active peptic ulcer; prolonged or invasive CPR;

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PCI Group	percutaneous coronary stenting	Eligible patients undergoing primary PCI.
Thrombolysis Group	Thrombolytic	Patients who meet the conditions for intravenous thrombolysis are included in the intravenous thrombolysis group. Regardless of whether the thrombolysis is successful or not, CAG examination is performed afterwards to clarify the vascular condition, and PCI is performed if necessary.

Primary Outcome Measures

Name	Time	Method
recanalization time	within 2 hours	From first medical contact(FMC) time to recanalization time.
recanalization	within 24 hours	Coronary angiography to check for recanalization after thrombolysis（Yes or No）

Secondary Outcome Measures

Name	Time	Method
Major bleeding event	7 day	Whether there is a major bleeding event with drug thrombolysis（Yes or No）
Malignant arrhythmia	12 hours	Malignant arrhythmia incidence

Trial Locations

Locations (1)

Shanghai Tenth People's Hospital; 🇨🇳 Shanghai, Shanghai, China