Thrombus Aspiration in Myocardial Infarction

NCT ID: NCT01093404

Last Updated: 2016-07-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

7243 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-07-31

Study Completion Date

2013-08-31

Brief Summary

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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.

Detailed Description

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Conditions

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Acute Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Thrombus aspiration

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

Group Type EXPERIMENTAL

Thrombus aspiration

Intervention Type PROCEDURE

Aspiration of thrombus material before angioplasty

Standard balloon angioplasty (PCI)

Group Type ACTIVE_COMPARATOR

Thrombus aspiration

Intervention Type PROCEDURE

Aspiration of thrombus material before angioplasty

Interventions

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Thrombus aspiration

Aspiration of thrombus material before angioplasty

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role collaborator

Region Örebro County

OTHER

Sponsor Role lead

Responsible Party

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Ole Frobert, MD, PhD

MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ole Fröbert, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Region Örebro County

Locations

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Skejby Hospital, Aarhus University Hospital

Aarhus, , Denmark

Site Status

Landspitali University Hospital

Reykjavik, , Iceland

Site Status

Södra Älvsborgs sjukhus

Borås, , Sweden

Site Status

Mälarsjukhuset

Eskilstuna, , Sweden

Site Status

Falu lasarett

Falun, , Sweden

Site Status

Gävle sjukhus

Gävle, , Sweden

Site Status

Sahlgrenska sjukhuset

Gothenburg, , Sweden

Site Status

Östra sjukhuset

Gothenburg, , Sweden

Site Status

Hallands sjukhus

Halmstad, , Sweden

Site Status

Helsingborgs lasarett

Helsingborg, , Sweden

Site Status

Länssjukhuset Ryhov

Jönköping, , Sweden

Site Status

Länssjukhuset

Kalmar, , Sweden

Site Status

Blekingesjukhuset

Karlskrona, , Sweden

Site Status

Svensk PCI AB, Centralsjukhuset

Karlstad, , Sweden

Site Status

Centralsjukhuset

Kristianstad, , Sweden

Site Status

Universitetssjukhuset

Linköping, , Sweden

Site Status

Sunderby sjukhus

Luleå, , Sweden

Site Status

Lund University Hospital

Lund, , Sweden

Site Status

Skånes universitetssjukhus

Malmo, , Sweden

Site Status

Örebro University Hospital

Örebro, , Sweden

Site Status

Karolinska universitetssjukhuset

Solna, , Sweden

Site Status

Danderyds sjukhus

Stockholm, , Sweden

Site Status

S:t Görans sjukhus

Stockholm, , Sweden

Site Status

Södersjukhuset

Stockholm, , Sweden

Site Status

Länssjukhuset

Sundsvall, , Sweden

Site Status

Norra Älvsborgs länssjukhus

Trollhättan, , Sweden

Site Status

Universitetssjukhuset

Umeå, , Sweden

Site Status

Uppsala University Hospital

Uppsala, , Sweden

Site Status

Centrallasarettet

Västerås, , Sweden

Site Status

Countries

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Denmark Iceland Sweden

References

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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.

Reference Type DERIVED
PMID: 26856224 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26077585 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25176395 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23991656 (View on PubMed)

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.

Reference Type DERIVED
PMID: 21146656 (View on PubMed)

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.

Reference Type DERIVED
PMID: 20550973 (View on PubMed)

Related Links

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Other Identifiers

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SCAAR-001

Identifier Type: -

Identifier Source: org_study_id

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