NL-OMON39042
Recruiting
Phase 2
ltrasound contrast agents to facilitate sonothrombolysis in patients with acute myocardial infarction - Sonolysis study
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- 10003216
- Sponsor
- Vrije Universiteit Medisch Centrum
- Enrollment
- 60
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •\* 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
Exclusion Criteria
- •\* 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
Outcomes
Primary Outcomes
Not specified
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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 disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]EUCTR2012-000323-41-NOHelse Bergen, Haukeland University Hospital