Thrombus Aspiration in Myocardial Infarction - Full Text View

Purpose

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.

Condition	Intervention
Acute Myocardial Infarction	Procedure: Thrombus aspiration


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia

Resource links provided by NLM:

MedlinePlus related topics: Angioplasty Health Facilities Heart Attack

U.S. FDA Resources

Further study details as provided by University Hospital Orebro:

Primary Outcome Measures:

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.

Secondary Outcome Measures:

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 ]


Enrollment:	7243
Study Start Date:	July 2010
Study Completion Date:	August 2013
Primary Completion Date:	March 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Thrombus aspiration Thrombus aspiration is then followed by standard balloon angioplasty (PCI).	Procedure: Thrombus aspiration Aspiration of thrombus material before angioplasty
Active Comparator: Standard balloon angioplasty (PCI)	Procedure: Thrombus aspiration Aspiration of thrombus material before angioplasty

Eligibility


Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01093404

Locations


Denmark
Skejby Hospital, Aarhus University Hospital
Aarhus, Denmark
Iceland
Landspitali University Hospital
Reykjavik, Iceland
Sweden
Södra Älvsborgs sjukhus
Borås, Sweden
Mälarsjukhuset
Eskilstuna, Sweden
Falu lasarett
Falun, Sweden
Östra sjukhuset
Gothenburg, Sweden
Gävle sjukhus
Gävle, Sweden
Sahlgrenska sjukhuset
Göteborg, Sweden
Hallands sjukhus
Halmstad, Sweden
Helsingborgs lasarett
Helsingborg, Sweden
Länssjukhuset Ryhov
Jönköping, Sweden
Länssjukhuset
Kalmar, Sweden
Blekingesjukhuset
Karlskrona, Sweden
Svensk PCI AB, Centralsjukhuset
Karlstad, Sweden
Centralsjukhuset
Kristianstad, Sweden
Universitetssjukhuset
Linköping, Sweden
Sunderby sjukhus
Luleå, Sweden
Lund University Hospital
Lund, Sweden
Skånes universitetssjukhus
Malmö, Sweden
Karolinska universitetssjukhuset
Solna, Sweden
Södersjukhuset
Stockholm, Sweden
S:t Görans sjukhus
Stockholm, Sweden
Danderyds sjukhus
Stockholm, Sweden
Länssjukhuset
Sundsvall, Sweden
Norra Älvsborgs länssjukhus
Trollhättan, Sweden
Universitetssjukhuset
Umeå, Sweden
Uppsala University Hospital
Uppsala, Sweden
Centrallasarettet
Västerås, Sweden
Örebro University Hospital
Örebro, Sweden

Sponsors and Collaborators

University Hospital Orebro

Uppsala University

Investigators


Principal Investigator:	Ole Fröbert, MD, PhD	University Hospital Orebro

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided by University Hospital Orebro

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Lagerqvist B, Fröbert O, Olivecrona GK, Gudnason T, Maeng M, Alström P, Andersson J, Calais F, Carlsson J, Collste O, Götberg M, Hårdhammar P, Ioanes D, Kallryd A, Linder R, Lundin A, Odenstedt J, Omerovic E, Puskar V, Tödt T, Zelleroth E, Östlund 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.

Fröbert O, Lagerqvist B, Olivecrona GK, Omerovic E, Gudnason T, Maeng M, Aasa M, Angerås O, Calais F, Danielewicz M, Erlinge D, Hellsten L, Jensen U, Johansson AC, Kåregren A, Nilsson J, Robertson L, Sandhall L, Sjögren 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.

Fröbert 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.

Fröbert 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.


Responsible Party:	Ole Frobert, MD, PhD, University Hospital Orebro
ClinicalTrials.gov Identifier:	NCT01093404 History of Changes
Other Study ID Numbers:	SCAAR-001
Study First Received:	March 22, 2010
Last Updated:	January 7, 2014
Health Authority:	Sweden: Regional Ethics Review Board, Uppsala

Keywords provided by University Hospital Orebro:


Heart disease Myocardial infarction Angioplasty Thrombus aspiration

Additional relevant MeSH terms:


Infarction Myocardial Infarction Cardiovascular Diseases Heart Diseases Ischemia	Myocardial Ischemia Necrosis Pathologic Processes Vascular Diseases

ClinicalTrials.gov processed this record on February 27, 2015

Thrombus Aspiration in Myocardial Infarction (TASTE)