Thrombus Aspiration in Myocardial Infarction

Region Örebro County7,243 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

7,243

Conditions

Acute Myocardial Infarction

Interventions

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (29)

Skejby Hospital, Aarhus University Hospital

Aarhus, Denmark

Landspitali University Hospital

Reykjavik, Iceland

Södra Älvsborgs sjukhus

Borås, Sweden

Mälarsjukhuset

Eskilstuna, Sweden

Falu lasarett

Falun, Sweden

Gävle sjukhus

Gävle, Sweden

Sahlgrenska sjukhuset

Gothenburg, Sweden

Östra sjukhuset

Gothenburg, Sweden

Hallands sjukhus

Halmstad, Sweden

Helsingborgs lasarett

Helsingborg, Sweden

...and 19 more locations

Outcomes

Primary Outcomes

All-cause death

Death from any cause will be registered via national registries during the first 30 days after study inclusion.

Time frame: 30 days

Secondary Outcomes

Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization

Time frame: 30 days to 10 years

Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure

Time frame: 30 days to 10 years

Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions

Time frame: 1 year

Length of hospital stay

Time frame: 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.

Time frame: 3 hours

All-cause death

Time frame: 1 year to 10 years