Thrombus Aspiration in Myocardial Infarction (TASTE)
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| ClinicalTrials.gov Identifier: NCT01093404 |
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Recruitment Status
:
Completed
First Posted
: March 25, 2010
Last Update Posted
: July 11, 2016
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Sponsor:
Region Örebro County
Collaborator:
Uppsala University
Information provided by (Responsible Party):
Ole Frobert, MD, PhD, Region Örebro County
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Acute Myocardial Infarction | Procedure: Thrombus aspiration | Not Applicable |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 7243 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Single (Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Thrombus Aspiration in ST- Elevation Myocardial Infarction in Scandinavia |
| Study Start Date : | July 2010 |
| Actual Primary Completion Date : | March 2013 |
| Actual Study Completion Date : | August 2013 |
| Arm | Intervention/treatment |
|---|---|
|
Experimental: Thrombus aspiration
Thrombus aspiration is then followed by standard balloon angioplasty (PCI).
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Procedure: Thrombus aspiration
Aspiration of thrombus material before angioplasty
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| Active Comparator: Standard balloon angioplasty (PCI) |
Procedure: Thrombus aspiration
Aspiration of thrombus material before angioplasty
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Primary Outcome Measures
:
- All-cause death [ Time Frame: 30 days ]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 ]
- 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 ]
- Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions [ Time Frame: 1 year ]
- Length of hospital stay [ Time Frame: 1 month ]
- TIMI-flow grade [ Time Frame: 3 hours ]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 ]
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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 | |
| 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, Sweden | |
| Örebro University Hospital | |
| Örebro, Sweden | |
Sponsors and Collaborators
Region Örebro County
Uppsala University
Investigators
| Principal Investigator: | Ole Fröbert, MD, PhD | Region Örebro County |
Additional Information:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Ole Frobert, MD, PhD, MD, PhD, Region Örebro County |
| ClinicalTrials.gov Identifier: | NCT01093404 History of Changes |
| Other Study ID Numbers: |
SCAAR-001 |
| First Posted: | March 25, 2010 Key Record Dates |
| Last Update Posted: | July 11, 2016 |
| Last Verified: | July 2016 |
Keywords provided by Ole Frobert, MD, PhD, Region Örebro County:
|
Heart disease Myocardial infarction Angioplasty Thrombus aspiration |
Additional relevant MeSH terms:
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Infarction Myocardial Infarction ST Elevation Myocardial Infarction Thrombosis Ischemia Pathologic Processes |
Necrosis Myocardial Ischemia Heart Diseases Cardiovascular Diseases Vascular Diseases Embolism and Thrombosis |