Thrombus Aspiration in Myocardial Infarction (TASTE)

July 7, 2016 updated by: Ole Frobert, MD, PhD, Region Örebro County

Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

7243

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aarhus, Denmark
        • Skejby Hospital, Aarhus University Hospital
  • Iceland
      • Reykjavik, Iceland
        • Landspitali University Hospital
  • Sweden
      • Borås, Sweden
        • Södra Älvsborgs sjukhus
      • Eskilstuna, Sweden
        • Mälarsjukhuset
      • Falun, Sweden
        • Falu Lasarett
      • Gothenburg, Sweden
        • Östra sjukhuset
      • Gävle, Sweden
        • Gavle Sjukhus
      • Göteborg, Sweden
        • Sahlgrenska Sjukhuset
      • Halmstad, Sweden
        • Hallands Sjukhus
      • Helsingborg, Sweden
        • Helsingborgs Lasarett
      • Jönköping, Sweden
        • Länssjukhuset Ryhov
      • Kalmar, Sweden
        • Länssjukhuset
      • Karlskrona, Sweden
        • Blekingesjukhuset
      • Karlstad, Sweden
        • Svensk PCI AB, Centralsjukhuset
      • Kristianstad, Sweden
        • Centralsjukhuset
      • Linköping, Sweden
        • Universitetssjukhuset
      • Luleå, Sweden
        • Sunderby Sjukhus
      • Lund, Sweden
        • Lund University Hospital
      • Malmö, Sweden
        • Skånes Universitetssjukhus
      • Solna, Sweden
        • Karolinska Universitetssjukhuset
      • Stockholm, Sweden
        • Danderyds sjukhus
      • Stockholm, Sweden
        • Södersjukhuset
      • Stockholm, Sweden
        • S:t Görans sjukhus
      • Sundsvall, Sweden
        • Länssjukhuset
      • Trollhättan, Sweden
        • Norra Älvsborgs Länssjukhus
      • Umeå, Sweden
        • Universitetssjukhuset
      • Uppsala, Sweden
        • Uppsala University Hospital
      • Västerås, Sweden
        • Centrallasarettet
      • Örebro, Sweden
        • Örebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
All-cause death
Time Frame: 30 days
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
Time Frame: 30 days to 10 years
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
30 days to 10 years
Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions
Time Frame: 1 year
1 year
Length of hospital stay
Time Frame: 1 month
1 month
TIMI-flow grade
Time Frame: 3 hours
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
Time Frame: 1 year to 10 years
1 year to 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Region Örebro County

Collaborators

Uppsala University

Investigators

  • Principal Investigator: Ole Fröbert, MD, PhD, Region Örebro County

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

March 1, 2013

Study Completion (Actual)

August 1, 2013

Study Registration Dates

First Submitted

March 22, 2010

First Submitted That Met QC Criteria

March 24, 2010

First Posted (Estimate)

March 25, 2010

Study Record Updates

Last Update Posted (Estimate)

July 11, 2016

Last Update Submitted That Met QC Criteria

July 7, 2016

Last Verified

July 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SCAAR-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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