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

Study Overview
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Brief Summary
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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
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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)

Official Title
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Intravenous Thrombolysis Versus Primary PCI for Recanalization Time in Acute ST-segment Elevation Myocardial Infarction in the Context of the COVID-19 Outbreak: a Prospective, Multicenter, Nonrandomized Controlled Registry Study.

Conditions
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STEMI - ST Elevation Myocardial Infarction

Intervention / Treatment
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* Drug: Thrombolytic
* Procedure: percutaneous coronary stenting


Participation Criteria
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Eligibility Criteria
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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;

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: non-randomized control
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombolysis Group<br>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. | Drug: Thrombolytic<br>* Standard intravenous thrombolysis.<br>* Other names: intravenous thrombolysis;|
| Other: PCI Group<br>Eligible patients undergoing primary PCI. | Procedure: percutaneous coronary stenting<br>* Percutaneous coronary stenting<br>* Other names: PCI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| recanalization | Coronary angiography to check for recanalization after thrombolysis（Yes or No） | within 24 hours | 
| recanalization time | From first medical contact(FMC) time to recanalization time. | within 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major bleeding event | Whether there is a major bleeding event with drug thrombolysis（Yes or No） | 7 day | 
| Malignant arrhythmia | Malignant arrhythmia incidence | 12 hours |