Back to resultsEffectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
Primary Purpose
STEMI
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Thrombus aspiration
Sponsored by
About this trial
This is an interventional treatment trial for STEMI
Eligibility Criteria
Inclusion Criteria:
- (1) Age ≥ 18 years; (2) Voluntary signing of informed consent; (3) Onset of 12 hours STEMI patients who underwent PCI reperfusion therapy within time; (4) The guidewire passes through the lesion and the blood Heavy embolism load (TIMI thrombus classification ≥ 3).
Exclusion Criteria:
- (1) Hemodynamics is unstable or there is cardiogenic shock; (2) After thrombolytic therapy; (3) The expected survival time is less than 6 months due to non-cardiac diseases; (4) Past trips Coronary artery bypass graft patients; (5) Participate in other drug and device research within 30 days; (6) Before surgery, clear active gastrointestinal bleeding or other contraindications for taking dual antiplatelet drugs (7) Patients deemed unsuitable for enrollment by other researchers
Sites / Locations
- Shenzhen People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Thrombus aspiration
control group
Arm Description
Outcomes
Primary Outcome Measures
Adverse cardiovascular events
Including cardiogenic death, recurring myocardial infarction Stent thrombosis or target vessel revascularization
Secondary Outcome Measures
Full Information
NCT ID
NCT05043597
First Posted
August 25, 2021
Last Updated
September 4, 2021
Sponsor
Shenzhen People's Hospital
1. Study Identification
Unique Protocol Identification Number
NCT05043597
Brief Title
Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
Official Title
Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
Study Type
Interventional
2. Study Status
Record Verification Date
September 2021
Overall Recruitment Status
Unknown status
Study Start Date
March 1, 2020 (Actual)
Primary Completion Date
January 1, 2023 (Anticipated)
Study Completion Date
February 28, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shenzhen People's Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This study intends to evaluate thrombus on the basis of different methods for evaluating thrombus load The effect of aspiration on the prognosis of STEMI patients with high thrombotic load Provide a basis for the standardized use of aspiration; at the same time, discover the best benefit groups for thrombus aspiration
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
STEMI
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
3838 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Thrombus aspiration
Arm Type
Experimental
Arm Title
control group
Arm Type
No Intervention
Intervention Type
Procedure
Intervention Name(s)
Thrombus aspiration
Intervention Description
Thrombus aspiration
Primary Outcome Measure Information:
Title
Adverse cardiovascular events
Description
Including cardiogenic death, recurring myocardial infarction Stent thrombosis or target vessel revascularization
Time Frame
3 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
(1) Age ≥ 18 years; (2) Voluntary signing of informed consent; (3) Onset of 12 hours STEMI patients who underwent PCI reperfusion therapy within time; (4) The guidewire passes through the lesion and the blood Heavy embolism load (TIMI thrombus classification ≥ 3).
Exclusion Criteria:
(1) Hemodynamics is unstable or there is cardiogenic shock; (2) After thrombolytic therapy; (3) The expected survival time is less than 6 months due to non-cardiac diseases; (4) Past trips Coronary artery bypass graft patients; (5) Participate in other drug and device research within 30 days; (6) Before surgery, clear active gastrointestinal bleeding or other contraindications for taking dual antiplatelet drugs (7) Patients deemed unsuitable for enrollment by other researchers
Facility Information:
Facility Name
Shenzhen People's Hospital
City
Shenzhen
Country
China
12. IPD Sharing Statement
Learn more about this trial
Effectiveness Evaluation in Thrombus Aspiration in Patients With STEMI and High Thrombotic Load
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