ST-segment Elevation Myocardial Infarction (STEMI), Total Occlusion of Coronary Artery, Primary Percutaneous Coronary Intervention
Conditions
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.
Interventions
DEVICEExport Catheter
Manual thrombus aspiration with the use of export catheter during primary PCI
DEVICEBalloon catheter
Predilatation with balloon catheter
Sponsors
Medtronic
National Institute of Cardiovascular Diseases, Pakistan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (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.
Intervention model description
Manual thrombus aspiration (use of export catheter) followed by primary PCI
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post thrombus aspiration TIMI flow | Immediately after export/balloon | Immediate TIMI flow after export/balloon |
| Slow/No-reflow | Immediately after procedure | TIMI 0-II flow |
| Major adverse cardiac events | 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 |
Countries
Pakistan
Contacts
Primary ContactDr Faiza Farooq, FCPS
Backup ContactTahir Saghir, FCPS
Outcome results
None listed