acute myocardial infarction MedDRA version: 18.0 Level: PT Classification code 10000891 Term: Acute myocardial infarction System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: BYETTA
Pharmaceutical Form: Solution for injection in pre-filled pen
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Concentration unit: µg microgram(s)
Concentration type: equal
Co
Sponsors
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: ? Men or women > =18 years of age ? STEMI characterized by 2 mm ST elevation in 2 or more V1 through V4 leads or presumed new left bundle branch block with minimum of 1 mm concordant ST elevation or 1 mV ST-segment elevation in the limb lead (II, III and aVF, I, aVL) and V4?V6. ? Patients presenting within 6 hours of chest pain. 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 360 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 360
Exclusion criteria
Exclusion criteria: ? Known hypersensitivity to exenatide or any of the excipients ? Known contraindication to CMR imaging such as significant claustrophobia, severe allergy to gadolinium chelate contrast, severe renal insufficiency (defined as estimated glomerular filtration rate [eGFR] 1 at the time of diagnostic coronary angiography. These patients will be excluded from the analysis of infarct size but will be included in the safety analysis. ? Pregnant women ? Patients with loss of consciousness or confused, not able to read the information and to sign the writing consent ? Patients with oro-tracheal intubation ? Patients with cardiogenic shock persisting 48 hours after reperfusion
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: ? To determine the effectiveness of combination therapy with RIC and exenatide to limit MI size in patients with STEMI receiving pPCI.;Secondary Objective: ? To evaluate the safety of combination therapy with RIC and exenatide in patients with STEMI. ? To determine the effects of the study treatments on the rate of effective myocardial reperfusion, left ventricular end-diastolic volume and ejection fraction, and microvascular obstruction (MVO). ? To evaluate the effect of the study treatments on the frequency of MACE. ? To assess the impact of RIC and exenatide, alone and in combination, through a phase III randomised controlled clinical trial on MI size in patients with STEMI;Primary end point(s): MI, measured by late gadolinium enhancement in CMRI 2-7 days after pPCI, and expressed as percent of left ventricular mass.;Timepoint(s) of evaluation of this end point: 2-7 days after pPCI | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): a) Myocardial salvage index defined as the difference between infarct size and area at risk, defined by the T2 CMRI and expressed as a percent of total LV mass, divided by the area at risk. b) Transmurality index, defined as the ratio of the mass of myocardium showing late gadolinium enhancement to the mass of the myocardial segment containing it. c) Markers of successful myocardial reperfusion: ST-segment resolution 90 minutes post-pPCI , TIMI flow and frame-count post-pPCI , and TIMI blush grade . d) LV end-diastolic volume and LVEF, as determined by CMRI. e) Volume of myocardium with MVO determined by late gadolinium enhancement expressed as percent of infarct size. f) MACE rate during hospitalization, defined as death, non-fatal myocardial rupture, or appearance or worsening of heart failure during the hospitalization period.;Timepoint(s) of evaluation of this end point: 2-7 days after pPCI | — |
Countries
Spain
Contacts
Public ContactDavid García-Dorado García
Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
Outcome results
None listed