Thrombus Aspiration in Myocardial Infarction

Not Applicable

Completed

• Conditions: Acute Myocardial Infarction

• 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

Study Timeline

• Study First Submitted: 2010-03-22
• Study First Submitted QC: 2010-03-24
• Study First Posted: 2010-03-25
• Study Start: 2010-07
• Primary Completion: 2013-03
• Study Completion: 2013-08
• Status Verified: 2016-07
• Last Update Submitted: 2016-07-07
• Last Update Posted: 2016-07-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7243

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

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)

Skejby Hospital, Aarhus University Hospital; 🇩🇰 Aarhus, Denmark

Landspitali University Hospital; 🇮🇸 Reykjavik, Iceland

Södra Älvsborgs sjukhus; 🇸🇪 Borås, Sweden

Mälarsjukhuset; 🇸🇪 Eskilstuna, Sweden

Falu lasarett; 🇸🇪 Falun, Sweden

Östra sjukhuset; 🇸🇪 Gothenburg, Sweden

Gävle sjukhus; 🇸🇪 Gävle, Sweden

Sahlgrenska sjukhuset; 🇸🇪 Göteborg, Sweden

Hallands sjukhus; 🇸🇪 Halmstad, Sweden

Helsingborgs lasarett; 🇸🇪 Helsingborg, Sweden

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