Acute Myocardial Infarction
Conditions
Keywords
Heart disease, Myocardial infarction, Angioplasty, Thrombus aspiration
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.
Interventions
PROCEDUREThrombus aspiration
Aspiration of thrombus material before angioplasty
Sponsors
Uppsala University
Region Örebro County
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| All-cause death | 30 days | Death from any cause will be registered via national registries during the first 30 days after study inclusion. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Length of hospital stay | 1 month | — |
| 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 | — |
| Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization | 30 days to 10 years | — |
Countries
Denmark, Iceland, Sweden
Outcome results
None listed