E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
ST elevation myocardial infarction |
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E.1.1.1 | Medical condition in easily understood language |
Acute myocardial infarction |
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E.1.1.2 | Therapeutic area | Diseases [C] - Cardiovascular Diseases [C14] |
MedDRA Classification |
E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To assess feasibility and safety of sonothrombolysis in the ambulance for ST elevation myocardial infarction prior to PCI, measured by angiographic occurence of pre-defined arrhythmia and shock and extent of sonothrombolysis protocol completion |
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E.2.2 | Secondary objectives of the trial |
To assess efficacy of sonothrombolysis in the ambulance for ST elevation myocardial infarction prior to PCI, measured by angiographic patency rate and ST segment resolution and other imaging parameters. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
- Within 12 hours of symptom onset
- Age ≥ 30 years
- Adequate apical and/or parasternal images by echocardiography
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E.4 | Principal exclusion criteria |
- Previous coronary bypass surgery
- Cardiogenic shock
- Known or suspected hypersensitivity to ultrasound contrast agent used for the study
- Known bleeding diathesis or contraindication to glycoprotein IIB/IIIA inhibitors, anticoagulants or aspirin
- Known large right to left intracardiac shunts
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E.5 End points |
E.5.1 | Primary end point(s) |
- Safety, assessed by the occurrence of ventricular arrhythmias defined as sustained ventricular tachycardia and/or ventricular fibrillation and the occurrence of shock defined as a systolic blood pressure (SBP) <100mmHg in combination with tachycardia (HR > 100/min), after initiation of sonothrombolysis and before percutaneous coronary intervention.
- Technical feasibility will be assessed by extent of sonothrombolysis completion during ambulance transfer and quality of the images. Sonothrombolysis completion will be measured by counting the number of applied high MI impulses and quality of the images will be assessed by counting the amount of visible segments during sonothrombolysis.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
The same day of inclusion |
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E.5.2 | Secondary end point(s) |
- Cumulative ST-elevation resolution
- Angiographic patency rate on coronary angiography
- Myocardial infarct size by delayed enhancement imaging, as well as the salvageability index, defined as the difference between extent of delayed enhancement by Gd MRI and the T2 weighted double or triple inversion spin echo assessment of risk area, divided by the area at risk. Presence and extent of myocardial injury. Scar size, LVEF and other quantitative assessments as function of LV mass/volume.
- Frequency of left ventricular remodeling
- Myocardial perfusion on follow up contrast enhanced echocardiography
- Maximum CPK and troponin
- Occurrence of adverse events (AEs), serious adverse events (SAEs), suspected unexpected serious adverse reactions (SUSARs) and six month event free survival. AE is defined as any untoward medical occurrence in the patient during the intervention period (one hour after sonothrombolysis initiation), whether or not considered causally related to the intervention. SAE is defined as any untoward medical occurrence that at any dose results in a life-threatening situation or death, or requires (prolongation of) hospitalization or results in a persistent or significant disability during 6 month follow up. SUSARs are defined as the occurrence of hypotension, ventricular rhythm disorders, cardiac arrest and/or anaphylaxis within one hour after sonothrombolysis initiation. Six-month event free survival is calculated from treatment initiation to six months afterwards, where events include death, congestive heart failure, life threatening arrhythmias, recurrence of ACS and need for prophylactic defibrillator.
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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LVLS. No DSMB. If SUSARs / SAEs / MACE are unusually higher, the trial will be terminated |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |