Back to resultsThrombolysis in STEMI Patients Compared With pPCI on Recanalization Time in the Context of the COVID-19 Outbreak. (RESCUE-STEMI)
Primary Purpose
STEMI - ST Elevation Myocardial Infarction
Status
Recruiting
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thrombolytic
percutaneous coronary stenting
Sponsored by
About this trial
This is an interventional treatment trial for STEMI - ST Elevation Myocardial Infarction
Eligibility Criteria
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;
Sites / Locations
- Shanghai Tenth People's HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
Thrombolysis Group
PCI Group
Arm Description
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.
Eligible patients undergoing primary PCI.
Outcomes
Primary Outcome Measures
recanalization
Coronary angiography to check for recanalization after thrombolysis（Yes or No）
recanalization time
From first medical contact(FMC) time to recanalization time.
Secondary Outcome Measures
Major bleeding event
Whether there is a major bleeding event with drug thrombolysis（Yes or No）
Malignant arrhythmia
Malignant arrhythmia incidence
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05354128
Brief Title
Thrombolysis in STEMI Patients Compared With pPCI on Recanalization Time in the Context of the COVID-19 Outbreak.
Acronym
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.
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
April 1, 2022 (Actual)
Primary Completion Date
November 30, 2022 (Anticipated)
Study Completion Date
April 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ya-Wei Xu
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. 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.
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI - ST Elevation Myocardial Infarction
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
non-randomized control
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
120 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thrombolysis Group
Arm Type
Experimental
Arm Description
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.
Arm Title
PCI Group
Arm Type
Other
Arm Description
Eligible patients undergoing primary PCI.
Intervention Type
Drug
Intervention Name(s)
Thrombolytic
Other Intervention Name(s)
intravenous thrombolysis
Intervention Description
Standard intravenous thrombolysis.
Intervention Type
Procedure
Intervention Name(s)
percutaneous coronary stenting
Other Intervention Name(s)
PCI
Intervention Description
Percutaneous coronary stenting
Primary Outcome Measure Information:
Title
recanalization
Description
Coronary angiography to check for recanalization after thrombolysis（Yes or No）
Time Frame
within 24 hours
Title
recanalization time
Description
From first medical contact(FMC) time to recanalization time.
Time Frame
within 2 hours
Secondary Outcome Measure Information:
Title
Major bleeding event
Description
Whether there is a major bleeding event with drug thrombolysis（Yes or No）
Time Frame
7 day
Title
Malignant arrhythmia
Description
Malignant arrhythmia incidence
Time Frame
12 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jun Zhang, Doctor
Phone
+86 15000420881
Email
zhangjun_njmu2011@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yawei Xu, Doctor
Organizational Affiliation
Shanghai 10th People's Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Shanghai Tenth People's Hospital
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200072
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jun Zhang, M.D.
Phone
+8615000420881
Email
zhangjun_njmu2011@163.com
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Thrombolysis in STEMI Patients Compared With pPCI on Recanalization Time in the Context of the COVID-19 Outbreak.
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