Thrombus Aspiration in Myocardial Infarction (TASTE)

This study has been completed.
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Ole Frobert, University Hospital Orebro
ClinicalTrials.gov Identifier:
NCT01093404
First received: March 22, 2010
Last updated: January 7, 2014
Last verified: January 2014
  Purpose

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.


Condition Intervention
Acute Myocardial Infarction
Procedure: Thrombus aspiration

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia

Resource links provided by NLM:


Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:
  • All-cause death [ Time Frame: 30 days ] [ Designated as safety issue: No ]
    Death from any cause will be registered via national registries during the first 30 days after study inclusion.


Secondary Outcome Measures:
  • Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization [ Time Frame: 30 days to 10 years ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Length of hospital stay [ Time Frame: 1 month ] [ Designated as safety issue: No ]
  • TIMI-flow grade [ Time Frame: 3 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 1 year to 10 years ] [ Designated as safety issue: No ]

Enrollment: 7243
Study Start Date: July 2010
Study Completion Date: August 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093404

Locations
Denmark
Skejby Hospital, Aarhus University Hospital
Aarhus, Denmark
Iceland
Landspitali University Hospital
Reykjavik, Iceland
Sweden
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
Länssjukhuset Ryhov
Jönköping, Sweden
Länssjukhuset
Kalmar, Sweden
Blekingesjukhuset
Karlskrona, Sweden
Svensk PCI AB, Centralsjukhuset
Karlstad, Sweden
Centralsjukhuset
Kristianstad, Sweden
Universitetssjukhuset
Linköping, Sweden
Sunderby sjukhus
Luleå, Sweden
Lund University Hospital
Lund, Sweden
Skånes universitetssjukhus
Malmö, Sweden
Karolinska universitetssjukhuset
Solna, Sweden
Södersjukhuset
Stockholm, Sweden
S:t Görans sjukhus
Stockholm, Sweden
Danderyds sjukhus
Stockholm, Sweden
Länssjukhuset
Sundsvall, Sweden
Norra Älvsborgs länssjukhus
Trollhättan, Sweden
Universitetssjukhuset
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Centrallasarettet
Västerås, Sweden
Örebro University Hospital
Örebro, Sweden
Sponsors and Collaborators
University Hospital Orebro
Uppsala University
Investigators
Principal Investigator: Ole Fröbert, MD, PhD University Hospital Orebro
  More Information

Additional Information:
No publications provided by University Hospital Orebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Ole Frobert, MD, PhD, University Hospital Orebro
ClinicalTrials.gov Identifier: NCT01093404     History of Changes
Other Study ID Numbers: SCAAR-001
Study First Received: March 22, 2010
Last Updated: January 7, 2014
Health Authority: Sweden: Regional Ethics Review Board, Uppsala

Keywords provided by University Hospital Orebro:
Heart disease
Myocardial infarction
Angioplasty
Thrombus aspiration

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Thrombosis
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Embolism and Thrombosis

ClinicalTrials.gov processed this record on September 15, 2014