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Reduction Of Microvascular Injury Utilizing Sonolysis

Reduction Of Microvascular Injury Utilizing Sonolysis - ROMIUS

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON41625
Enrollment
20
Registered
2014-08-07
Start date
2014-09-24
Completion date
Unknown
Last updated
2024-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

acute coronary syndrome myocardial infarction

Interventions

Immediately before treatment with primary PCI, patients presenting with a STEMI will undergo intravenous infusion of an UCA and diagnostic ultrasound for 15 minutes. After primary PCI patients will

Sponsors

Vrije Universiteit Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: * Age > 18 years * acute onset (< 6 hours) * diagnosed with STEMI according to the criteria of the ACC * initial oral informed consent

Exclusion criteria

Exclusion criteria: * Clinical instability * Known allergy to ultrasound contrast agents * Any reason judged by the investigators to hamper inclusion

Design outcomes

Primary

MeasureTime frame
* Echocardiographic and enzymatic infarct size * Microvascular obstruction and haemorrhage on MRI measurements Safety and feasibility of therapeutic option

Secondary

MeasureTime frame
* Other adverse events * Other Serious adverse events * Incidence of Major Adverse Cardiac Events (MACE) Other patient and / or MRI and echocardiographic parameters

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)