microcirculation recovery in acute myocardial infarctio

Phase 1

• Conditions: ST elevation myocardial infarction; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2018-001277-24-NL
• Lead Sponsor: VU University Medical Center (VUmc)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2019-08-20
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: Not specified
• Target Recruitment: 60

Inclusion Criteria

Patients presenting with STEMI with:
- = 2mm ST-segment elevation in 2 anterior or lateral leads; or
- = 1 mm ST-segment elevation in 2 inferior leads
- = 1mm ST-segment elevation in lateral leads (I, aVL, V5, V6)
AND
- Persistence of ST-elevation of more than 30% after PCI in the lead with the highest ST-elevation on the ECG after PCI compared to the ECG before PCI
- Within 12 hours of symptom onset
- Age = 30 years
- Adequate apical and/or parasternal images by echocardiography
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 30

Exclusion Criteria

-Previous coronary bypass surgery
-Cardiogenic shock
-Known or suspected hypersensitivity to ultrasound contrast agent used for the study
-Life expectancy of less than two months or terminally ill
-Known bleeding diathesis or contraindication to glycoprotein IIB/IIIA inhibitors, anticoagulants or aspirin
-Known large right to left intracardiac shunts

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess efficacy of sonothrombolysis post PCI, in patients with persistent ST elevation after PCI, measured with mm ST elevation 60 minutes post initiation of study protocol.;<br> Secondary Objective: - Partial (>50%) and complete (=70%) ST-segment resolution.<br> - Size of the infarct as measured by late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (CMR) assessed on day 3-5 days and 4-6 months after infarction (on patients who can have a CMR)<br> - Left ventricular remodelling as assessed by contrast enhanced echocardiography.<br> - The composite of all-cause death, cardiogenic shock, need for defibrillator placement, or congestive heart failure (CHF) through day 180.<br> ;Primary end point(s): mm ST elevation at 60 minutes post initiation of study protocol;Timepoint(s) of evaluation of this end point: 60 minutes post initiation of study protocol

Secondary Outcome Measures

Name	Time	Method
Timepoint(s) of evaluation of this end point: see above;<br> Secondary end point(s): - Partial (>50%) and complete (=70%) ST-segment resolution (day 1).<br> - Size of the infarct as measured by late gadolinium enhancement (LGE) on cardiac magnetic resonance imaging (CMR) assessed on day 3-5 days and 4-6 months after infarction (on patients who can have a CMR)<br> - Left ventricular remodelling as assessed by contrast enhanced echocardiography (6 months).<br> - The composite of all-cause death, cardiogenic shock, need for defibrillator placement, or congestive heart failure (CHF) through day 180.<br>