Other Clinical Trial - Use of Export in Primary Percutaneous Coronary

Status Recruiting

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Infarction
Myocardial Infarction
Primary Percutaneous Coronary Intervention
ST Elevation Myocardial Infarction
ST-segment Elevation Myocardial Infarction (STEMI)
Total Occlusion of Coronary Artery

Clinical Trial Details

NCT number	NCT05510661
Study type	Interventional
Source	National Institute of Cardiovascular Diseases, Pakistan
Contact	Dr Faiza Farooq, FCPS
Phone	+923002426460
Email	drffaziz@gmail.com
Status	Recruiting
Phase	N/A
Start date	January 15, 2024
Completion date	May 31, 2026

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Use of Export in Primary Percutaneous Coronary Intervention — EPISOO

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms