NL-OMON39042招募中2 期
ltrasound contrast agents to facilitate sonothrombolysis in patients with acute myocardial infarction - Sonolysis study
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •* age 18-80 years
- •* acute onset (< 6 hours)
- •* sum ST elevation > 6mm + V3R > 1mm in case of an inferior infarction
- •* diagnosed with STEMI according to the criteria of the ACC (19)
- •* initial oral informed consent
排除标准
- •* previous myocardial infarction
- •* clinical instability
- •* pregnancy / breast feeding
- •* known pulmonary hypertension (>90 mmHg)
- •* known allergy to ultrasound contrast agents
- •* any reason judged by the investigators to hamper inclusion
- •* Contraindications to alteplase
研究者
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OR-SASS is a multi-centre PROBE (prospective randomised, open-label, blinded endpoint) trial, designed to establish the superiority of contrast-enhanced sonothrombolysis given within 4½ hours after stroke onset in consecutively admitted patients with acute ischaemic stroke, as compared with 1) standard iv thrombolysis with tenecteplase (TNK) or alteplase (tPA), and 2) no specific treatment in patients not eligible for thrombolytic treatment.All patients found eligible for thrombolysis may enter the thrombolysis-arm (NOR-SASS I), all patientswith contraindications to thrombolysis within the 4 ½ hour time window may enter the no-thrombolysis-arm(NOR-SASS II).MedDRA version: 14.1Level: PTClassification code 10061256Term: Ischaemic strokeSystem Organ Class: 10029205 - Nervous system disordersEUCTR2012-000323-41-NOHelse Bergen, Haukeland University Hospital