Thrombus Aspiration in Myocardial Infarction (TASTE)
This study is ongoing, but not recruiting participants.
Sponsor:
University Hospital Orebro
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
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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:
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 |
| Estimated 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
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:
No publications provided by University Hospital Orebro
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| 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: | March 27, 2013 |
| Health Authority: | Sweden: Regionala etikprövningsnämnden i Uppsala |
Keywords provided by University Hospital Orebro:
|
Heart disease Myocardial infarction Angioplasty Thrombus aspiration |
Additional relevant MeSH terms:
|
Infarction Myocardial Infarction Thrombosis Ischemia Pathologic Processes Necrosis |
Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis |
ClinicalTrials.gov processed this record on June 18, 2013