Thrombus Aspiration in Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Treatment of myocardial infarction (blood clot in the arteries of the heart) has improved after introduction of 24/7 balloon angioplasty to open the blocked artery. However, the clot itself is not routinely removed but recent data in smaller trials indicate that this might improve recovery and prognosis. In this multicenter study of 5000 patients referred to Scandinavian hospitals for myocardial infarction the investigators test the hypothesis that patients randomized to treatment with thrombus aspiration (removing the blood clot by manual suction) before conventional angioplasty will have a reduced risk of death, fewer rehospitalisations, fewer new myocardial infarctions, reduced risk of heart failure, better coronary artery flow after angioplasty and greater reduction of infarct size compared to patients randomized to conventional angioplasty alone.

Official Title
-----------------
Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia

Conditions
-----------------
Acute Myocardial Infarction

Intervention / Treatment
-----------------
* Procedure: Thrombus aspiration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with a diagnosis of ST-segment elevation myocardial infarction Correspondence between ECG findings and culprit artery pathoanatomy A minimum of 50% stenosis in culprit artery by visual estimate Possibility to perform thrombus aspiration Exclusion Criteria: Need for emergency coronary artery bypass grafting Inability to provide informed consent Age below 18 years Previous randomization in the TASTE trial

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thrombus aspiration<br>Thrombus aspiration is then followed by standard balloon angioplasty (PCI). | Procedure: Thrombus aspiration<br>* Aspiration of thrombus material before angioplasty<br>|
| Active Comparator: Standard balloon angioplasty (PCI)<br> | Procedure: Thrombus aspiration<br>* Aspiration of thrombus material before angioplasty<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause death | Death from any cause will be registered via national registries during the first 30 days after study inclusion. | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization |  | 30 days to 10 years | 
| Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure |  | 30 days to 10 years | 
| Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions |  | 1 year | 
| Length of hospital stay |  | 1 month | 
| TIMI-flow grade | TIMI-flow, or Thrombolysis in Myocardial Infarction grading of flow is a semiquantitative method to assess coronary artery flow following balloon angioplasty. | 3 hours | 
| All-cause death |  | 1 year to 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart disease, Myocardial infarction, Angioplasty, Thrombus aspiration