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| Name | Class |
|---|---|
| Medtronic | INDUSTRY |
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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.
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;
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Group | Experimental | Manual thrombus aspiration (use of export catheter) followed by primary PCI |
|
| Control group | Active Comparator | Predilatation with balloon catheter (≤2.00 mm diameter) followed by primary PCI |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Export Catheter | Device | Manual thrombus aspiration with the use of export catheter during primary PCI |
|
| Measure | Description | Time Frame |
|---|---|---|
| Post thrombus aspiration TIMI flow | Immediate TIMI flow after export/balloon | Immediately after export/balloon |
| Slow/No-reflow | TIMI 0-II flow | Immediately after procedure |
| 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 | In-hospital, at 1 month, and at 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Fiaza Farooq, FCPS | National Institute of Cardiovascular Diseases (NICVD), Karachi, Pakistan | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Institute of Cardiovascular Diseases | Karachi | Sindh | 75510 | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Result | 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. |
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| ID | Term |
|---|---|
| D000072657 | ST Elevation Myocardial Infarction |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
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Manual thrombus aspiration (use of export catheter) followed by primary PCI
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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.
| Balloon catheter | Device | Predilatation with balloon catheter |
|
| D014652 |
| Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |