NCT01093404

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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7,243

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2010

Typical duration for not_applicable

Geographic Reach
3 countries

29 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 22, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

March 25, 2010

Completed
3 months until next milestone

Study Start

First participant enrolled

July 1, 2010

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2013

Completed
Last Updated

July 11, 2016

Status Verified

July 1, 2016

Enrollment Period

2.7 years

First QC Date

March 22, 2010

Last Update Submit

July 7, 2016

Conditions

Keywords

Heart diseaseMyocardial infarctionAngioplastyThrombus aspiration

Outcome Measures

Primary Outcomes (1)

  • All-cause death

    Death from any cause will be registered via national registries during the first 30 days after study inclusion.

    30 days

Secondary Outcomes (6)

  • Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization

    30 days to 10 years

  • Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure

    30 days to 10 years

  • Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions

    1 year

  • Length of hospital stay

    1 month

  • TIMI-flow grade

    3 hours

  • +1 more secondary outcomes

Study Arms (2)

Thrombus aspiration

EXPERIMENTAL

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

Procedure: Thrombus aspiration

Standard balloon angioplasty (PCI)

ACTIVE COMPARATOR
Procedure: Thrombus aspiration

Interventions

Aspiration of thrombus material before angioplasty

Standard balloon angioplasty (PCI)Thrombus aspiration

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Need for emergency coronary artery bypass grafting
  • Inability to provide informed consent
  • Age below 18 years
  • Previous randomization in the TASTE trial

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (29)

Skejby Hospital, Aarhus University Hospital

Aarhus, Denmark

Location

Landspitali University Hospital

Reykjavik, Iceland

Location

Södra Älvsborgs sjukhus

Borås, Sweden

Location

Mälarsjukhuset

Eskilstuna, Sweden

Location

Falu lasarett

Falun, Sweden

Location

Gävle sjukhus

Gävle, Sweden

Location

Sahlgrenska sjukhuset

Gothenburg, Sweden

Location

Östra sjukhuset

Gothenburg, Sweden

Location

Hallands sjukhus

Halmstad, Sweden

Location

Helsingborgs lasarett

Helsingborg, Sweden

Location

Länssjukhuset Ryhov

Jönköping, Sweden

Location

Länssjukhuset

Kalmar, Sweden

Location

Blekingesjukhuset

Karlskrona, Sweden

Location

Svensk PCI AB, Centralsjukhuset

Karlstad, Sweden

Location

Centralsjukhuset

Kristianstad, Sweden

Location

Universitetssjukhuset

Linköping, Sweden

Location

Sunderby sjukhus

Luleå, Sweden

Location

Lund University Hospital

Lund, Sweden

Location

Skånes universitetssjukhus

Malmo, Sweden

Location

Örebro University Hospital

Örebro, Sweden

Location

Karolinska universitetssjukhuset

Solna, Sweden

Location

Danderyds sjukhus

Stockholm, Sweden

Location

S:t Görans sjukhus

Stockholm, Sweden

Location

Södersjukhuset

Stockholm, Sweden

Location

Länssjukhuset

Sundsvall, Sweden

Location

Norra Älvsborgs länssjukhus

Trollhättan, Sweden

Location

Universitetssjukhuset

Umeå, Sweden

Location

Uppsala University Hospital

Uppsala, Sweden

Location

Centrallasarettet

Västerås, Sweden

Location

Related Publications (6)

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

  • 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.

Related Links

MeSH Terms

Conditions

Heart DiseasesMyocardial Infarction

Condition Hierarchy (Ancestors)

Cardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Ole Fröbert, MD, PhD

    Region Örebro County

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD

Study Record Dates

First Submitted

March 22, 2010

First Posted

March 25, 2010

Study Start

July 1, 2010

Primary Completion

March 1, 2013

Study Completion

August 1, 2013

Last Updated

July 11, 2016

Record last verified: 2016-07

Locations