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Thrombus Aspiration in Myocardial Infarction (TASTE)

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ClinicalTrials.gov Identifier: NCT01093404
Recruitment Status : Completed
First Posted : March 25, 2010
Last Update Posted : July 11, 2016
Sponsor:
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Ole Frobert, MD, PhD, Region Örebro County

Study Description
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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.

Condition or disease Intervention/treatment Phase
Acute Myocardial Infarction Procedure: Thrombus aspiration Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7243 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia
Study Start Date : July 2010
Actual Primary Completion Date : March 2013
Actual Study Completion Date : August 2013

Resource links provided by the National Library of Medicine


Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization [ Time Frame: 30 days to 10 years ]
  2. 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 ]
  3. Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions [ Time Frame: 1 year ]
  4. Length of hospital stay [ Time Frame: 1 month ]
  5. 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.

  6. All-cause death [ Time Frame: 1 year to 10 years ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
Danderyds sjukhus
Stockholm, Sweden
S:t Görans sjukhus
Stockholm, Sweden
Södersjukhuset
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
Region Örebro County
Uppsala University
Investigators
Principal Investigator: Ole Fröbert, MD, PhD Region Örebro County
More Information
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Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Ole Frobert, MD, PhD, MD, PhD, Region Örebro County
ClinicalTrials.gov Identifier: NCT01093404     History of Changes
Other Study ID Numbers: SCAAR-001
First Posted: March 25, 2010    Key Record Dates
Last Update Posted: July 11, 2016
Last Verified: July 2016

Keywords provided by Ole Frobert, MD, PhD, Region Örebro County:
Heart disease
Myocardial infarction
Angioplasty
Thrombus aspiration

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