Microvascular Recovery in Acute MI, a multi center, prospective, randomized, single blind parallel-group comparison of sonothrombolysis versus standard of care performed after (post) coronary reperfusion (primary PCI).

Microvascular Recovery in Acute MI, a multi center, prospective, randomized, single blind parallel-group comparison of sonothrombolysis versus standard of care performed after (post) coronary reperfusion (primary PCI). - MRUSMI

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON52724

Enrollment

Registered

2019-08-02

Start date

2019-09-17

Completion date

Unknown

Last updated

2024-04-15

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

Conditions

myocardial infarction and microcirculation

Interventions

MRUSMI Sonothrombolysis: Intermittent diagnostic high mechanical index (MI) at 1.1 MI using an iE33 to the myocardium during an intravenous Luminity®, post PCI for 30 minutes Control : Standard of c

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: Patients presenting with STEMI within 12 hours of symptom onset and persisting ST-elevation on the ECG after PCI >=30% in the lead with the highest elevation compared to baseline ECG Age >=30 years. Adequate images with echocardiography

Exclusion criteria

Exclusion criteria: 1. Previous coronary bypass surgery 2. Cardiogenic shock 3. Known or suspected hypersensitivity to ultrasound contrast agent used for the study 4. Known bleeding diathesis or contraindication to glycoprotein 2b/3a inhibitors, anticoagulants, or aspirin 6. Known large right to left intracardiac shunts

Design outcomes

Primary

Measure	Time frame
Som of ST-segment elevation after 60 min post initiation of Study Protocol	—

Secondary

Measure	Time frame
- Partial (>50%) and complete (>=70%) ST-segment resolution. - Size of the infarct as measured by late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (CMR) assessed on day 3-7 days and 4-6 months after infarction (on patients who can have a CMR) - Left ventricular remodelling as assessed by contrast enhanced echocardiography. - The composite of all-cause death, cardiogenic shock, need for defibrillator placement, or congestive heart failure (CHF) through day 180	—

Measure

Time frame

- Partial (>50%) and complete (>=70%) ST-segment resolution. - Size of the infarct as measured by late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (CMR) assessed on day 3-7 days and 4-6 months after infarction (on patients who can have a CMR) - Left ventricular remodelling as assessed by contrast enhanced echocardiography. - The composite of all-cause death, cardiogenic shock, need for defibrillator placement, or congestive heart failure (CHF) through day 180

—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)