Use of Export in Primary Percutaneous Coronary Intervention (EPISOO)
Use of Export in Primary Percutaneous Coronary Intervention, In-Hospital and Short-term Outcomes and Optimal Time of Export
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Sindh
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Karachi, Sindh, Pakistan, 75510
- National Institute of Cardiovascular Diseases
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention Group
Manual thrombus aspiration (use of export catheter) followed by primary PCI
|
Manual thrombus aspiration with the use of export catheter during primary PCI
Other Names:
|
|
Active Comparator: Control group
Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI
|
Predilatation with balloon catheter
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Post thrombus aspiration TIMI flow
Time Frame: Immediately after export/balloon
|
Immediate TIMI flow after export/balloon
|
Immediately after export/balloon
|
|
Slow/No-reflow
Time Frame: Immediately after procedure
|
TIMI 0-II flow
|
Immediately after procedure
|
|
Major adverse cardiac events
Time Frame: In-hospital, at 1 month, and at 6 months
|
It will include All-cause death, Cardiovascular death, Re- infarction, Heart Failure, Cardiogenic shock, Cerebrovascular events, Bleeding events, and Stent thrombosis
|
In-hospital, at 1 month, and at 6 months
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Dr Fiaza Farooq, FCPS, National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ERC-63/2021
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
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