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

NCT05354128 | Unknown

• 1 other identifier: RESCUE-STEMI
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

STEMI - ST Elevation Myocardial Infarction

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (2)

• Major bleeding event

  7 day

• Malignant arrhythmia

  12 hours

Study Arms (2)

Thrombolysis Group

EXPERIMENTAL

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

PCI Group

OTHER

Eligible patients undergoing primary PCI.

Procedure: percutaneous coronary stenting

Interventions

Thrombolytic DRUG

Standard intravenous thrombolysis.

Also known as: intravenous thrombolysis

Thrombolysis Group

percutaneous coronary stenting PROCEDURE

Percutaneous coronary stenting

Also known as: PCI

PCI Group

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;

Sponsors & Collaborators

• Ya-Wei Xu: lead

Study Sites (1)

Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China

RECRUITING

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Interventions

Fibrinolytic Agents

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Fibrin Modulating Agents; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Cardiovascular Agents; Therapeutic Uses; Hematologic Agents

Study Officials

• Yawei Xu, Doctor

  Shanghai 10th People's Hospital

  STUDY DIRECTOR

Central Study Contacts

Jun Zhang, Doctor

CONTACT

+86 15000420881; zhangjun_njmu2011@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of the Heart Center

Model Details: non-randomized control

Study Record Dates

• First Submitted: April 27, 2022
• First Posted: April 29, 2022
• Study Start: April 1, 2022
• Primary Completion: November 30, 2022
• Study Completion: April 30, 2023
• Last Updated: May 26, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)