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Thrombus Aspiration in Myocardial Infarction

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赞助商
Region Örebro County
合作者
Uppsala University

关键词

抽象

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.

日期

最后验证: 06/30/2016
首次提交: 03/21/2010
提交的预估入学人数: 03/23/2010
首次发布: 03/24/2010
上次提交的更新: 07/06/2016
最近更新发布: 07/10/2016
实际学习开始日期: 06/30/2010
预计主要完成日期: 02/28/2013
预计完成日期: 07/31/2013

状况或疾病

Acute Myocardial Infarction

干预/治疗

Procedure: Thrombus aspiration

-

手臂组

干预/治疗
Experimental: Thrombus aspiration
Thrombus aspiration is then followed by standard balloon angioplasty (PCI).
Active Comparator: Standard balloon angioplasty (PCI)

资格标准

有资格学习的年龄 18 Years 至 18 Years
有资格学习的性别All
接受健康志愿者
标准

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

结果

主要结果指标

1. All-cause death [30 days]

Death from any cause will be registered via national registries during the first 30 days after study inclusion.

次要成果指标

1. Time to re-hospitalization with nonfatal reinfarction, heart failure and target vessel revascularization [30 days to 10 years]

2. Time to all-cause death or new myocardial infarction (first occurring) or in hospital treatment for heart failure [30 days to 10 years]

3. Time to acute coronary occlusion, stent thrombosis and restenosis in treated lesions [1 year]

4. Length of hospital stay [1 month]

5. TIMI-flow grade [3 hours]

TIMI-flow, or Thrombolysis in Myocardial Infarction grading of flow is a semiquantitative method to assess coronary artery flow following balloon angioplasty.

6. All-cause death [1 year to 10 years]

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