Clinical trial NCT01093404: Thrombus Aspiration in Myocardial Infarction
Official title: Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Myocardial Infarction
Keywords: Heart disease
Myocardial infarction
Angioplasty
Thrombus aspiration
Lead sponsor: Region Örebro County
Sponsor class: OTHER
Collaborators: name: Uppsala University
First posted: 2010-03-25
Enrollment: 7243
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: All-cause death
timeFrame: 30 days
Secondary outcomes:
measure: Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization
timeFrame: 30 days to 10 years
measure: Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure
timeFrame: 30 days to 10 years
measure: Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions
timeFrame: 1 year
measure: Length of hospital stay
timeFrame: 1 month
measure: TIMI-flow grade
timeFrame: 3 hours
measure: All-cause death
timeFrame: 1 year to 10 years
Other outcomes:
Locations:
city: Aarhus
country: Denmark
facility: Skejby Hospital, Aarhus University Hospital
city: Reykjavik
country: Iceland
facility: Landspitali University Hospital
city: Borås
country: Sweden
facility: Södra Älvsborgs sjukhus
city: Eskilstuna
country: Sweden
facility: Mälarsjukhuset
city: Falun
country: Sweden
facility: Falu lasarett
city: Gothenburg
country: Sweden
facility: Östra sjukhuset
city: Gävle
country: Sweden
facility: Gävle sjukhus
city: Göteborg
country: Sweden
facility: Sahlgrenska sjukhuset
city: Halmstad
country: Sweden
facility: Hallands sjukhus
city: Helsingborg
country: Sweden
facility: Helsingborgs lasarett
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov
city: Kalmar
country: Sweden
facility: Länssjukhuset
city: Karlskrona
country: Sweden
facility: Blekingesjukhuset
city: Karlstad
country: Sweden
facility: Svensk PCI AB, Centralsjukhuset
city: Kristianstad
country: Sweden
facility: Centralsjukhuset
city: Linköping
country: Sweden
facility: Universitetssjukhuset
city: Luleå
country: Sweden
facility: Sunderby sjukhus
city: Lund
country: Sweden
facility: Lund University Hospital
city: Malmö
country: Sweden
facility: Skånes universitetssjukhus
city: Solna
country: Sweden
facility: Karolinska universitetssjukhuset
city: Stockholm
country: Sweden
facility: Danderyds sjukhus
city: Stockholm
country: Sweden
facility: S:t Görans sjukhus
city: Stockholm
country: Sweden
facility: Södersjukhuset
city: Sundsvall
country: Sweden
facility: Länssjukhuset
city: Trollhättan
country: Sweden
facility: Norra Älvsborgs länssjukhus
city: Umeå
country: Sweden
facility: Universitetssjukhuset
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Västerås
country: Sweden
facility: Centrallasarettet
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Region Örebro County
name: Ole Fröbert, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.
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.
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.