AzTrials
AzTrials

Acute Myocardial InfarctionTASTENCT01093404

Thrombus Aspiration in Myocardial Infarction

A study testing Thrombus aspiration in people with Acute Myocardial Infarction, run by Region Örebro County at 29 sites in 3 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Thrombus aspiration
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
7,243 participants
Where
29 sitesin 3 countries
Study dates
Jul 2010to Aug 2013
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

29 sites in 3 countries.

29 sites in 3 countries

Sweden27 sites

  • Södra Älvsborgs sjukhus

    Borås

  • Mälarsjukhuset

    Eskilstuna

  • Falu lasarett

    Falun

  • Gävle sjukhus

    Gävle

  • Sahlgrenska sjukhuset

    Gothenburg

  • Östra sjukhuset

    Gothenburg

  • Hallands sjukhus

    Halmstad

  • Helsingborgs lasarett

    Helsingborg

  • Länssjukhuset Ryhov

    Jönköping

  • Länssjukhuset

    Kalmar

  • Blekingesjukhuset

    Karlskrona

  • Svensk PCI AB, Centralsjukhuset

    Karlstad

  • Centralsjukhuset

    Kristianstad

  • Universitetssjukhuset

    Linköping

  • Sunderby sjukhus

    Luleå

  • Lund University Hospital

    Lund

  • Skånes universitetssjukhus

    Malmö

  • Örebro University Hospital

    Örebro

  • Karolinska universitetssjukhuset

    Solna

  • Danderyds sjukhus

    Stockholm

  • S:t Görans sjukhus

    Stockholm

  • Södersjukhuset

    Stockholm

  • Länssjukhuset

    Sundsvall

  • Norra Älvsborgs länssjukhus

    Trollhättan

  • Universitetssjukhuset

    Umeå

  • Uppsala University Hospital

    Uppsala

  • Centrallasarettet

    Västerås

Other trials in Sweden

Denmark1 site

  • Skejby Hospital, Aarhus University Hospital

    Aarhus

Other trials in Denmark

Iceland1 site

  • Landspitali University Hospital

    Reykjavik

Other trials in Iceland

About this study

Official title: 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.

Being tested
Thrombus aspiration
Keywords
Heart disease, Myocardial infarction, Angioplasty, Thrombus aspiration
Medical subject headings
Heart Diseases, Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Thrombus aspirationProcedure or surgery

    Aspiration of thrombus material before angioplasty

Study groups in NCT01093404
Study groupRoleWhat they receive
Thrombus aspirationExperimentalThrombus aspiration is then followed by standard balloon angioplasty (PCI).
Receives: Procedure: Thrombus aspiration
Standard balloon angioplasty (PCI)Active comparatorNot described
Receives: Procedure: Thrombus aspiration

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. All-cause death

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

    Measured: 30 days

Secondary outcomes (6)

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

    Measured: 30 days to 10 years

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

    Measured: 30 days to 10 years

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

    Measured: 1 year

  4. Length of hospital stay

    Measured: 1 month

  5. 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.

    Measured: 3 hours

  6. All-cause death

    Measured: 1 year to 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Mar 2010 (estimated)
  2. Study startJul 2010
  3. Primary completionMar 2013
  4. Study completionAug 2013

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
7,243 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01093404
Sponsor's protocol ID
SCAAR-001
Acronym
TASTE
Status last verified
Jul 2016
First submitted
22 Mar 2010
Last updated
11 Jul 2016
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 26856224

  • 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.

    PubMed 26077585

  • 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.

    PubMed 25176395

  • 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.

    PubMed 23991656

  • 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.

    PubMed 21146656

  • 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.

    PubMed 20550973

Questions about this trial

What is this clinical trial studying?

A study testing Thrombus aspiration in people with Acute Myocardial Infarction, run by Region Örebro County at 29 sites in 3 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in Sweden, Denmark, Iceland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

All-cause death (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01093404, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jul 2016.

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