Thrombus Aspiration in Myocardial Infarction
- Conditions
- Acute Myocardial Infarction
- Interventions
- Procedure: Thrombus aspiration
- Registration Number
- NCT01093404
- Lead Sponsor
- Region Örebro County
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 7243
- 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
- Need for emergency coronary artery bypass grafting
- Inability to provide informed consent
- Age below 18 years
- Previous randomization in the TASTE trial
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Thrombus aspiration Thrombus aspiration Thrombus aspiration is then followed by standard balloon angioplasty (PCI). Standard balloon angioplasty (PCI) Thrombus aspiration -
- Primary Outcome Measures
Name Time Method All-cause death 30 days Death from any cause will be registered via national registries during the first 30 days after study inclusion.
- Secondary Outcome Measures
Name Time Method 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 3 hours TIMI-flow, or Thrombolysis in Myocardial Infarction grading of flow is a semiquantitative method to assess coronary artery flow following balloon angioplasty.
All-cause death 1 year to 10 years
Trial Locations
- Locations (27)
Mälarsjukhuset
🇸🇪Eskilstuna, Sweden
Landspitali University Hospital
🇮🇸Reykjavik, Iceland
Länssjukhuset
🇸🇪Sundsvall, Sweden
Östra sjukhuset
🇸🇪Gothenburg, Sweden
Blekingesjukhuset
🇸🇪Karlskrona, Sweden
Sahlgrenska sjukhuset
🇸🇪Göteborg, Sweden
Örebro University Hospital
🇸🇪Örebro, Sweden
Centrallasarettet
🇸🇪Västerås, Sweden
Centralsjukhuset
🇸🇪Kristianstad, Sweden
S:t Görans sjukhus
🇸🇪Stockholm, Sweden
Skejby Hospital, Aarhus University Hospital
🇩🇰Aarhus, Denmark
Södra Älvsborgs sjukhus
🇸🇪Borås, Sweden
Falu lasarett
🇸🇪Falun, Sweden
Svensk PCI AB, Centralsjukhuset
🇸🇪Karlstad, Sweden
Helsingborgs lasarett
🇸🇪Helsingborg, Sweden
Länssjukhuset Ryhov
🇸🇪Jönköping, Sweden
Universitetssjukhuset
🇸🇪Umeå, Sweden
Karolinska universitetssjukhuset
🇸🇪Solna, Sweden
Gävle sjukhus
🇸🇪Gävle, Sweden
Hallands sjukhus
🇸🇪Halmstad, Sweden
Sunderby sjukhus
🇸🇪Luleå, Sweden
Lund University Hospital
🇸🇪Lund, Sweden
Skånes universitetssjukhus
🇸🇪Malmö, Sweden
Danderyds sjukhus
🇸🇪Stockholm, Sweden
Uppsala University Hospital
🇸🇪Uppsala, Sweden
Södersjukhuset
🇸🇪Stockholm, Sweden
Norra Älvsborgs länssjukhus
🇸🇪Trollhättan, Sweden