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    Summary
    EudraCT Number:2019-001883-31
    Sponsor's Protocol Code Number:CARMRUSMIAMBULANCE20190823
    National Competent Authority:Netherlands - Competent Authority
    Clinical Trial Type:EEA CTA
    Trial Status:Completed
    Date on which this record was first entered in the EudraCT database:2020-02-25
    Trial results
    Index
    A. PROTOCOL INFORMATION
    B. SPONSOR INFORMATION
    C. APPLICANT IDENTIFICATION
    D. IMP IDENTIFICATION
    D.8 INFORMATION ON PLACEBO
    E. GENERAL INFORMATION ON THE TRIAL
    F. POPULATION OF TRIAL SUBJECTS
    G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
    N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
    P. END OF TRIAL
    Expand All   Collapse All
    A. Protocol Information
    A.1Member State ConcernedNetherlands - Competent Authority
    A.2EudraCT number2019-001883-31
    A.3Full title of the trial
    Microvascular Recovery using contrast Ultrasound in ST-elevation Myocardial Infarction in the ambulance (MRUSMI-Ambulance)
    A.3.1Title of the trial for lay people, in easily understood, i.e. non-technical, language
    Microcirculation recovery in acute myocardial infarction using ultrasound in the ambulance
    A.3.2Name or abbreviated title of the trial where available
    MRUSMI-Ambulance
    A.4.1Sponsor's protocol code numberCARMRUSMIAMBULANCE20190823
    A.7Trial is part of a Paediatric Investigation Plan No
    A.8EMA Decision number of Paediatric Investigation Plan
    B. Sponsor Information
    B.Sponsor: 1
    B.1.1Name of SponsorVU Univesity Medical Center (VUmc)
    B.1.3.4CountryNetherlands
    B.3.1 and B.3.2Status of the sponsorNon-Commercial
    B.4 Source(s) of Monetary or Material Support for the clinical trial:
    B.4.1Name of organisation providing supportVU University Medical Center
    B.4.2CountryNetherlands
    B.5 Contact point designated by the sponsor for further information on the trial
    B.5.1Name of organisationVU University Medical Center (VUmc)
    B.5.2Functional name of contact pointOtto Kamp
    B.5.3 Address:
    B.5.3.1Street AddressDe Boelelaan 1117
    B.5.3.2Town/ cityAmsterdam
    B.5.3.3Post code1081 HV
    B.5.3.4CountryNetherlands
    B.5.4Telephone number0031204442454
    B.5.6E-mailo.kamp@amsterdamumc.nl
    D. IMP Identification
    D.IMP: 1
    D.1.2 and D.1.3IMP RoleTest
    D.2 Status of the IMP to be used in the clinical trial
    D.2.1IMP to be used in the trial has a marketing authorisation Yes
    D.2.1.1.1Trade name Luminity
    D.2.1.1.2Name of the Marketing Authorisation holderLantheus
    D.2.1.2Country which granted the Marketing AuthorisationNetherlands
    D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
    D.2.5.1Orphan drug designation number
    D.3 Description of the IMP
    D.3.1Product nameLuminity perflutren microspheres
    D.3.4Pharmaceutical form Solution for infusion
    D.3.4.1Specific paediatric formulation No
    D.3.7Routes of administration for this IMPIntravenous use
    D.3.11 The IMP contains an:
    D.3.11.1Active substance of chemical origin Yes
    D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
    The IMP is a:
    D.3.11.3Advanced Therapy IMP (ATIMP) No
    D.3.11.3.1Somatic cell therapy medicinal product No
    D.3.11.3.2Gene therapy medical product No
    D.3.11.3.3Tissue Engineered Product No
    D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) No
    D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product No
    D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy No
    D.3.11.5Radiopharmaceutical medicinal product No
    D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
    D.3.11.7Plasma derived medicinal product No
    D.3.11.8Extractive medicinal product No
    D.3.11.9Recombinant medicinal product No
    D.3.11.10Medicinal product containing genetically modified organisms No
    D.3.11.11Herbal medicinal product No
    D.3.11.12Homeopathic medicinal product No
    D.3.11.13Another type of medicinal product No
    D.8 Information on Placebo
    E. General Information on the Trial
    E.1 Medical condition or disease under investigation
    E.1.1Medical condition(s) being investigated
    ST elevation myocardial infarction
    E.1.1.1Medical condition in easily understood language
    Acute myocardial infarction
    E.1.1.2Therapeutic area Diseases [C] - Cardiovascular Diseases [C14]
    MedDRA Classification
    E.1.3Condition being studied is a rare disease No
    E.2 Objective of the trial
    E.2.1Main 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
    E.2.2Secondary 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.
    E.2.3Trial contains a sub-study No
    E.3Principal 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
    E.4Principal 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
    E.5 End points
    E.5.1Primary 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.
    E.5.1.1Timepoint(s) of evaluation of this end point
    The same day of inclusion
    E.5.2Secondary 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.
    E.5.2.1Timepoint(s) of evaluation of this end point
    Within 6 months
    E.6 and E.7 Scope of the trial
    E.6Scope of the trial
    E.6.1Diagnosis No
    E.6.2Prophylaxis No
    E.6.3Therapy Yes
    E.6.4Safety Yes
    E.6.5Efficacy Yes
    E.6.6Pharmacokinetic No
    E.6.7Pharmacodynamic No
    E.6.8Bioequivalence No
    E.6.9Dose response No
    E.6.10Pharmacogenetic No
    E.6.11Pharmacogenomic No
    E.6.12Pharmacoeconomic No
    E.6.13Others No
    E.7Trial type and phase
    E.7.1Human pharmacology (Phase I) No
    E.7.1.1First administration to humans No
    E.7.1.2Bioequivalence study No
    E.7.1.3Other No
    E.7.1.3.1Other trial type description
    E.7.2Therapeutic exploratory (Phase II) Yes
    E.7.3Therapeutic confirmatory (Phase III) Yes
    E.7.4Therapeutic use (Phase IV) No
    E.8 Design of the trial
    E.8.1Controlled No
    E.8.1.1Randomised No
    E.8.1.2Open Yes
    E.8.1.3Single blind No
    E.8.1.4Double blind No
    E.8.1.5Parallel group No
    E.8.1.6Cross over No
    E.8.1.7Other No
    E.8.2 Comparator of controlled trial
    E.8.2.1Other medicinal product(s) No
    E.8.2.2Placebo No
    E.8.2.3Other No
    E.8.2.4Number of treatment arms in the trial1
    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.8.5The trial involves multiple Member States No
    E.8.6 Trial involving sites outside the EEA
    E.8.6.1Trial being conducted both within and outside the EEA No
    E.8.6.2Trial being conducted completely outside of the EEA No
    E.8.7Trial 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
    LVLS. No DSMB. If SUSARs / SAEs / MACE are unusually higher, the trial will be terminated
    E.8.9 Initial estimate of the duration of the trial
    E.8.9.1In the Member State concerned years1
    E.8.9.1In the Member State concerned months
    E.8.9.1In the Member State concerned days
    F. Population of Trial Subjects
    F.1 Age Range
    F.1.1Trial has subjects under 18 No
    F.1.1.1In Utero No
    F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) No
    F.1.1.3Newborns (0-27 days) No
    F.1.1.4Infants and toddlers (28 days-23 months) No
    F.1.1.5Children (2-11years) No
    F.1.1.6Adolescents (12-17 years) No
    F.1.2Adults (18-64 years) Yes
    F.1.2.1Number of subjects for this age range: 5
    F.1.3Elderly (>=65 years) Yes
    F.1.3.1Number of subjects for this age range: 5
    F.2 Gender
    F.2.1Female Yes
    F.2.2Male Yes
    F.3 Group of trial subjects
    F.3.1Healthy volunteers No
    F.3.2Patients Yes
    F.3.3Specific vulnerable populations Yes
    F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
    F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
    F.3.3.3Pregnant women Information not present in EudraCT
    F.3.3.4Nursing women Information not present in EudraCT
    F.3.3.5Emergency situation Yes
    F.3.3.6Subjects incapable of giving consent personally No
    F.3.3.7Others No
    F.4 Planned number of subjects to be included
    F.4.1In the member state10
    F.5 Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)
    Normal care
    G. Investigator Networks to be involved in the Trial
    N. Review by the Competent Authority or Ethics Committee in the country concerned
    N.Competent Authority Decision Authorised
    N.Date of Competent Authority Decision2020-02-25
    N.Ethics Committee Opinion of the trial applicationFavourable
    N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
    N.Date of Ethics Committee Opinion2020-01-31
    P. End of Trial
    P.End of Trial StatusCompleted
    P.Date of the global end of the trial2024-01-09
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