Use of Export in Primary Percutaneous Coronary Intervention (EPISOO)
Primary Purpose
ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention
Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Export Catheter
Balloon catheter
Sponsored by
About this trial
This is an interventional treatment trial for ST-segment Elevation Myocardial Infarction (STEMI)
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
- Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
- Chest pain < 12 hours duration
- Total occlusion (TIMI 0 flow)
- Patients undergoing primary PCI
- Informed consent
Exclusion Criteria:
- Patients with prior history of cardiac related surgery or intervention
- Performance of a rescue PCI after thrombolysis
- Known existence of a disease resulting in a life expectancy of less than 6 months
- Killip class III, IV
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Intervention Group
Control group
Arm Description
Manual thrombus aspiration (use of export catheter) followed by primary PCI
Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI
Outcomes
Primary Outcome Measures
Post thrombus aspiration TIMI flow
Immediate TIMI flow after export/balloon
Slow/No-reflow
TIMI 0-II flow
Major adverse cardiac events
It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis
Secondary Outcome Measures
Full Information
NCT ID
NCT05510661
First Posted
June 30, 2021
Last Updated
August 31, 2023
Sponsor
National Institute of Cardiovascular Diseases, Pakistan
Collaborators
Medtronic
1. Study Identification
Unique Protocol Identification Number
NCT05510661
Brief Title
Use of Export in Primary Percutaneous Coronary Intervention
Acronym
EPISOO
Official Title
Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 15, 2023 (Anticipated)
Primary Completion Date
September 15, 2024 (Anticipated)
Study Completion Date
October 31, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National Institute of Cardiovascular Diseases, Pakistan
Collaborators
Medtronic
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Aim of this single center randomized open label trial with blinded in-hospital outcomes assessment is designed with aim to compare manual thrombus aspiration followed by percutaneous coronary intervention (PCI) strategy with PCI alone.
Detailed Description
Clinical benefit of manual aspiration has been a contentious point of debate and it is Class III indication in current clinical practice guidelines, however, recent observational data by Kumar D et al. showed benefits of usage of export in terms of favorable in-hospital outcomes and lesser complication rate in patients with total occlusion, furthermore, benefits of usage of export was observed to be directly associated with duration of chest pain at the time of thrombus aspiration. However, these observations are limited to immediate and in-hospital outcomes and data regarding efficacy of manual thrombus aspiration are not available.
Hence this single center randomized open label trial is designed with specific aim to test the following hypothesis for STEMI patients with total occlusion undergoing primary PCI;
Whether use of export catheter reduces in-hospital and short term adverse events
Whether use of export reduces slow flow or no reflow
Whether use of export reduces the use of intracoronary drugs
Whether use of export within 6 hours of symptom onset significantly reduces in-hospital and short term adverse events
Consecutively recruited patients will be randomized to either primary PCI with export or primary PCI alone group in 2:1 ratio. Post aspiration immediate TIMI flow will be observed and all the patients will be observed for adverse outcomes (MACE) and complications including slow flow/no-reflow. Follow-up intervals will be at the end of one month of randomization and end of 6 month of randomization.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Manual thrombus aspiration (use of export catheter) followed by primary PCI
Masking
Outcomes Assessor
Masking Description
Blinded in-hospital outcomes assessment will be insured by separating patients recruitment and follow-up team and follow-up team will be kept blinded of randomization. All the patients will be assigned a unique identity code and collected data will be stored against the assigned code.
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intervention Group
Arm Type
Experimental
Arm Description
Manual thrombus aspiration (use of export catheter) followed by primary PCI
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI
Intervention Type
Device
Intervention Name(s)
Export Catheter
Other Intervention Name(s)
Thrombus Aspiration
Intervention Description
Manual thrombus aspiration with the use of export catheter during primary PCI
Intervention Type
Device
Intervention Name(s)
Balloon catheter
Intervention Description
Predilatation with balloon catheter
Primary Outcome Measure Information:
Title
Post thrombus aspiration TIMI flow
Description
Immediate TIMI flow after export/balloon
Time Frame
Immediately after export/balloon
Title
Slow/No-reflow
Description
TIMI 0-II flow
Time Frame
Immediately after procedure
Title
Major adverse cardiac events
Description
It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis
Time Frame
In-hospital, at 1 month, and at 6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with:-Symptoms of myocardial ischemia lasting for ≥30 minutes
Definite ECG changes indicating STEMI: ST elevation of greater than 0.1 mV in two contiguous limb leads or 0.2 mV in two contiguous precordial leads
Chest pain < 12 hours duration
Total occlusion (TIMI 0 flow)
Patients undergoing primary PCI
Informed consent
Exclusion Criteria:
Patients with prior history of cardiac related surgery or intervention
Performance of a rescue PCI after thrombolysis
Known existence of a disease resulting in a life expectancy of less than 6 months
Killip class III, IV
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Faiza Farooq, FCPS
Phone
+923002426460
Email
drffaziz@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Tahir Saghir, FCPS
Phone
+923002199844
Email
tahirsaghir@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr Fiaza Farooq, FCPS
Organizational Affiliation
National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
Official's Role
Principal Investigator
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
Citation
Kumar D, Saghir T, Sial JA, Kumar R, Karim M, Huma ZE, Qamar N. Use of export vs. balloon in primary percutaneous coronary intervention, in-hospital outcomes and optimal export time. Journal of the American College of Cardiology. 2021 May 11; 77(18_Supplement_1): 1034.
Results Reference
result
Learn more about this trial
Use of Export in Primary Percutaneous Coronary Intervention
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