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

March 22, 2010
January 7, 2014
July 2010
March 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01093404 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Thrombus Aspiration in Myocardial Infarction
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Acute Myocardial Infarction
Procedure: Thrombus aspiration
Aspiration of thrombus material before angioplasty
  • Experimental: Thrombus aspiration
    Thrombus aspiration is then followed by standard balloon angioplasty (PCI).
    Intervention: Procedure: Thrombus aspiration
  • Active Comparator: Standard balloon angioplasty (PCI)
    Intervention: Procedure: Thrombus aspiration

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
7243
August 2013
March 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Denmark,   Iceland,   Sweden
 
NCT01093404
SCAAR-001
Yes
Ole Frobert, University Hospital Orebro
University Hospital Orebro
Uppsala University
Principal Investigator: Ole Fröbert, MD, PhD University Hospital Orebro
University Hospital Orebro
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP