Thrombus Aspiration in Myocardial Infarction (TASTE)

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborator:

Uppsala University

Information provided by (Responsible Party):

Ole Frobert, University Hospital Orebro

ClinicalTrials.gov Identifier:

NCT01093404

First received: March 22, 2010

Last updated: March 27, 2013

Last verified: March 2013

History of Changes

Tracking Information

First Received Date ^ICMJE

March 22, 2010

Last Updated Date

March 27, 2013

Start Date ^ICMJE

July 2010

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

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.

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Complete list of historical versions of study NCT01093404 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

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 ]

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

Thrombus Aspiration in Myocardial Infarction

Official Title ^ICMJE

Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase

Not Provided

Study Design ^ICMJE

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

Condition ^ICMJE

Acute Myocardial Infarction

Intervention ^ICMJE

Procedure: Thrombus aspiration

Aspiration of thrombus material before angioplasty

Study Arm (s)

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

Intervention: Procedure: Thrombus aspiration
Active Comparator: Standard balloon angioplasty (PCI)
Intervention: Procedure: Thrombus aspiration

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

7243

Estimated Completion Date

August 2013

Primary Completion Date

March 2013 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

Denmark, Iceland, Sweden

Administrative Information

NCT Number ^ICMJE

NCT01093404

Other Study ID Numbers ^ICMJE

SCAAR-001

Has Data Monitoring Committee

Yes

Responsible Party

Ole Frobert, University Hospital Orebro

Study Sponsor ^ICMJE

University Hospital Orebro

Collaborators ^ICMJE

Uppsala University

Investigators ^ICMJE

Principal Investigator:

Ole Fröbert, MD, PhD

University Hospital Orebro

Information Provided By

University Hospital Orebro

Verification Date

March 2013

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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