Thrombus Aspiration in Myocardial Infarction

Acute Myocardial Infarction Clinical Trial

— TASTE  

Official title:

Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01093404
• Other study ID #: SCAAR-001
• Status: Completed
• Phase: N/A
• First received: March 22, 2010
• Last updated: July 7, 2016
• Start date: July 2010
• Est. completion date: August 2013

Study information

• Verified date: July 2016
• Source: Region Örebro County
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethics Review Board, Uppsala
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7243
• Est. completion date: August 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Myocardial Infarction
• Infarction
• Myocardial Infarction
• Thrombosis

Intervention

Procedure:
• Thrombus aspiration
Aspiration of thrombus material before angioplasty

Locations

Country	Name	City	State
Denmark	Skejby Hospital, Aarhus University Hospital	Aarhus
Iceland	Landspitali University Hospital	Reykjavik
Sweden	Södra Älvsborgs sjukhus	Borås
Sweden	Mälarsjukhuset	Eskilstuna
Sweden	Falu lasarett	Falun
Sweden	Gävle sjukhus	Gävle
Sweden	Sahlgrenska sjukhuset	Göteborg
Sweden	Östra sjukhuset	Gothenburg
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	Örebro University Hospital	Örebro
Sweden	Karolinska universitetssjukhuset	Solna
Sweden	Danderyds sjukhus	Stockholm
Sweden	S:t Görans sjukhus	Stockholm
Sweden	Södersjukhuset	Stockholm
Sweden	Länssjukhuset	Sundsvall
Sweden	Norra Älvsborgs länssjukhus	Trollhättan
Sweden	Universitetssjukhuset	Umeå
Sweden	Uppsala University Hospital	Uppsala
Sweden	Centrallasarettet	Västerås

Sponsors (2)

Lead Sponsor	Collaborator
Region Örebro County	Uppsala University

Countries where clinical trial is conducted

Denmark,  Iceland,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	All-cause death	Death from any cause will be registered via national registries during the first 30 days after study inclusion.	30 days	No
Secondary	Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization		30 days to 10 years	No
Secondary	Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure		30 days to 10 years	No
Secondary	Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions		1 year	No
Secondary	Length of hospital stay		1 month	No
Secondary	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.	3 hours	No
Secondary	All-cause death		1 year to 10 years	No