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

STEMI - ST Elevation Myocardial Infarction Clinical Trial

— RESCUE-STEMI  

Official title:

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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05354128
• Other study ID #: RESCUE-STEMI
• Status: Recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: April 30, 2023

Study information

• Verified date: May 2022
• Source: Shanghai 10th People's Hospital
• Contact: Jun Zhang, Doctor
• Phone: +86 15000420881
• Email: zhangjun_njmu2011[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 120
• Est. completion date: April 30, 2023
• Est. primary completion date: November 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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;

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST Elevation Myocardial Infarction
• STEMI - ST Elevation Myocardial Infarction

Intervention

Drug:
• Thrombolytic
Standard intravenous thrombolysis.

Procedure:
• percutaneous coronary stenting
Percutaneous coronary stenting

Locations

Country	Name	City	State
China	Shanghai Tenth People's Hospital	Shanghai	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Ya-Wei Xu

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	recanalization	Coronary angiography to check for recanalization after thrombolysis(Yes or No)	within 24 hours
Primary	recanalization time	From first medical contact(FMC) time to recanalization time.	within 2 hours
Secondary	Major bleeding event	Whether there is a major bleeding event with drug thrombolysis(Yes or No)	7 day
Secondary	Malignant arrhythmia	Malignant arrhythmia incidence	12 hours