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Thrombus Aspiration in Myocardial Infarction (TASTE)

Primary Purpose

Acute Myocardial Infarction

Status
Completed
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
Thrombus aspiration
Sponsored by
Region Örebro County
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myocardial Infarction focused on measuring Heart disease, Myocardial infarction, Angioplasty, Thrombus aspiration

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Skejby Hospital, Aarhus University Hospital
  • Landspitali University Hospital
  • Södra Älvsborgs sjukhus
  • Mälarsjukhuset
  • Falu lasarett
  • Östra sjukhuset
  • Gävle sjukhus
  • Sahlgrenska sjukhuset
  • Hallands sjukhus
  • Helsingborgs lasarett
  • Länssjukhuset Ryhov
  • Länssjukhuset
  • Blekingesjukhuset
  • Svensk PCI AB, Centralsjukhuset
  • Centralsjukhuset
  • Universitetssjukhuset
  • Sunderby sjukhus
  • Lund University Hospital
  • Skånes universitetssjukhus
  • Karolinska universitetssjukhuset
  • Danderyds sjukhus
  • S:t Görans sjukhus
  • Södersjukhuset
  • Länssjukhuset
  • Norra Älvsborgs länssjukhus
  • Universitetssjukhuset
  • Uppsala University Hospital
  • Centrallasarettet
  • Örebro University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Thrombus aspiration

Standard balloon angioplasty (PCI)

Arm Description

Thrombus aspiration is then followed by standard balloon angioplasty (PCI).

Outcomes

Primary Outcome Measures

All-cause death
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 to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure
Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions
Length of hospital stay
TIMI-flow grade
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

Full Information

First Posted
March 22, 2010
Last Updated
July 7, 2016
Sponsor
Region Örebro County
Collaborators
Uppsala University
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1. Study Identification

Unique Protocol Identification Number
NCT01093404
Brief Title
Thrombus Aspiration in Myocardial Infarction
Acronym
TASTE
Official Title
Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia
Study Type
Interventional

2. Study Status

Record Verification Date
July 2016
Overall Recruitment Status
Completed
Study Start Date
July 2010 (undefined)
Primary Completion Date
March 2013 (Actual)
Study Completion Date
August 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Region Örebro County
Collaborators
Uppsala University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myocardial Infarction
Keywords
Heart disease, Myocardial infarction, Angioplasty, Thrombus aspiration

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
7243 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Thrombus aspiration
Arm Type
Experimental
Arm Description
Thrombus aspiration is then followed by standard balloon angioplasty (PCI).
Arm Title
Standard balloon angioplasty (PCI)
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
Thrombus aspiration
Intervention Description
Aspiration of thrombus material before angioplasty
Primary Outcome Measure Information:
Title
All-cause death
Description
Death from any cause will be registered via national registries during the first 30 days after study inclusion.
Time Frame
30 days
Secondary Outcome Measure Information:
Title
Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization
Time Frame
30 days to 10 years
Title
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
Title
Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions
Time Frame
1 year
Title
Length of hospital stay
Time Frame
1 month
Title
TIMI-flow grade
Description
TIMI-flow, or Thrombolysis in Myocardial Infarction grading of flow is a semiquantitative method to assess coronary artery flow following balloon angioplasty.
Time Frame
3 hours
Title
All-cause death
Time Frame
1 year to 10 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole Fröbert, MD, PhD
Organizational Affiliation
Region Örebro County
Official's Role
Principal Investigator
Facility Information:
Facility Name
Skejby Hospital, Aarhus University Hospital
City
Aarhus
Country
Denmark
Facility Name
Landspitali University Hospital
City
Reykjavik
Country
Iceland
Facility Name
Södra Älvsborgs sjukhus
City
Borås
Country
Sweden
Facility Name
Mälarsjukhuset
City
Eskilstuna
Country
Sweden
Facility Name
Falu lasarett
City
Falun
Country
Sweden
Facility Name
Östra sjukhuset
City
Gothenburg
Country
Sweden
Facility Name
Gävle sjukhus
City
Gävle
Country
Sweden
Facility Name
Sahlgrenska sjukhuset
City
Göteborg
Country
Sweden
Facility Name
Hallands sjukhus
City
Halmstad
Country
Sweden
Facility Name
Helsingborgs lasarett
City
Helsingborg
Country
Sweden
Facility Name
Länssjukhuset Ryhov
City
Jönköping
Country
Sweden
Facility Name
Länssjukhuset
City
Kalmar
Country
Sweden
Facility Name
Blekingesjukhuset
City
Karlskrona
Country
Sweden
Facility Name
Svensk PCI AB, Centralsjukhuset
City
Karlstad
Country
Sweden
Facility Name
Centralsjukhuset
City
Kristianstad
Country
Sweden
Facility Name
Universitetssjukhuset
City
Linköping
Country
Sweden
Facility Name
Sunderby sjukhus
City
Luleå
Country
Sweden
Facility Name
Lund University Hospital
City
Lund
Country
Sweden
Facility Name
Skånes universitetssjukhus
City
Malmö
Country
Sweden
Facility Name
Karolinska universitetssjukhuset
City
Solna
Country
Sweden
Facility Name
Danderyds sjukhus
City
Stockholm
Country
Sweden
Facility Name
S:t Görans sjukhus
City
Stockholm
Country
Sweden
Facility Name
Södersjukhuset
City
Stockholm
Country
Sweden
Facility Name
Länssjukhuset
City
Sundsvall
Country
Sweden
Facility Name
Norra Älvsborgs länssjukhus
City
Trollhättan
Country
Sweden
Facility Name
Universitetssjukhuset
City
Umeå
Country
Sweden
Facility Name
Uppsala University Hospital
City
Uppsala
Country
Sweden
Facility Name
Centrallasarettet
City
Västerås
Country
Sweden
Facility Name
Örebro University Hospital
City
Örebro
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
26856224
Citation
Calais F, Lagerqvist B, Leppert J, James SK, Frobert O. Thrombus aspiration in patients with large anterior myocardial infarction: A Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia trial substudy. Am Heart J. 2016 Feb;172:129-34. doi: 10.1016/j.ahj.2015.11.012. Epub 2015 Nov 22.
Results Reference
derived
PubMed Identifier
26077585
Citation
Frobert O, Calais F, James SK, Lagerqvist B. ST-elevation myocardial infarction, thrombus aspiration, and different invasive strategies. A TASTE trial substudy. J Am Heart Assoc. 2015 Jun 15;4(6):e001755. doi: 10.1161/JAHA.114.001755.
Results Reference
derived
PubMed Identifier
25176395
Citation
Lagerqvist B, Frobert O, Olivecrona GK, Gudnason T, Maeng M, Alstrom P, Andersson J, Calais F, Carlsson J, Collste O, Gotberg M, Hardhammar P, Ioanes D, Kallryd A, Linder R, Lundin A, Odenstedt J, Omerovic E, Puskar V, Todt T, Zelleroth E, Ostlund O, James SK. Outcomes 1 year after thrombus aspiration for myocardial infarction. N Engl J Med. 2014 Sep 18;371(12):1111-20. doi: 10.1056/NEJMoa1405707. Epub 2014 Sep 1.
Results Reference
derived
PubMed Identifier
23991656
Citation
Frobert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angeras O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Karegren A, Nilsson J, Robertson L, Sandhall L, Sjogren I, Ostlund O, Harnek J, James SK; TASTE Trial. Thrombus aspiration during ST-segment elevation myocardial infarction. N Engl J Med. 2013 Oct 24;369(17):1587-97. doi: 10.1056/NEJMoa1308789. Epub 2013 Aug 31. Erratum In: N Engl J Med. 2014 Aug 21;371(8):786.
Results Reference
derived
PubMed Identifier
21146656
Citation
Frobert O, Lagerqvist B, Gudnason T, Thuesen L, Svensson R, Olivecrona GK, James SK. Thrombus Aspiration in ST-Elevation myocardial infarction in Scandinavia (TASTE trial). A multicenter, prospective, randomized, controlled clinical registry trial based on the Swedish angiography and angioplasty registry (SCAAR) platform. Study design and rationale. Am Heart J. 2010 Dec;160(6):1042-8. doi: 10.1016/j.ahj.2010.08.040.
Results Reference
derived
PubMed Identifier
20550973
Citation
Frobert O, Lagerqvist B, Kreutzer M, Olivecrona GK, James SK. Thrombus aspiration in ST-elevation myocardial infarction in Sweden: a short report on real world outcome. Int J Cardiol. 2010 Dec 3;145(3):572-3. doi: 10.1016/j.ijcard.2010.05.044. Epub 2010 Jun 13. No abstract available.
Results Reference
derived
Links:
URL
http://www.ucr.uu.se/scaar/
Description
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