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

Sponsor
Ya-Wei Xu (Other)
Overall Status
Recruiting
CT.gov ID
NCT05354128
Collaborator
(none)
120
1
2
12.9
9.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
120 participants
Allocation:
Non-Randomized
Intervention Model:
Single Group Assignment
Intervention Model Description:
non-randomized controlnon-randomized control
Masking:
None (Open Label)
Primary Purpose:
Treatment
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.
Actual Study Start Date :
Apr 1, 2022
Anticipated Primary Completion Date :
Nov 30, 2022
Anticipated Study Completion Date :
Apr 30, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: Thrombolysis Group

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
Standard intravenous thrombolysis.
Other Names:
  • intravenous thrombolysis
  • Other: PCI Group

    Eligible patients undergoing primary PCI.

    Procedure: percutaneous coronary stenting
    Percutaneous coronary stenting
    Other Names:
  • PCI
  • Outcome Measures

    Primary Outcome Measures

    1. recanalization [within 24 hours]

      Coronary angiography to check for recanalization after thrombolysis(Yes or No)

    2. recanalization time [within 2 hours]

      From first medical contact(FMC) time to recanalization time.

    Secondary Outcome Measures

    1. Major bleeding event [7 day]

      Whether there is a major bleeding event with drug thrombolysis(Yes or No)

    2. Malignant arrhythmia [12 hours]

      Malignant arrhythmia incidence

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 85 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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;

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Shanghai Tenth People's Hospital Shanghai Shanghai China 200072

    Sponsors and Collaborators

    • Ya-Wei Xu

    Investigators

    • Study Director: Yawei Xu, Doctor, Shanghai 10th People's Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ya-Wei Xu, Director of the Heart Center, Shanghai 10th People's Hospital
    ClinicalTrials.gov Identifier:
    NCT05354128
    Other Study ID Numbers:
    • RESCUE-STEMI
    First Posted:
    Apr 29, 2022
    Last Update Posted:
    May 26, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 26, 2022