COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI trial
- Conditions
- acute myocardial infarctionMedDRA version: 18.0Level: PTClassification code 10000891Term: Acute myocardial infarctionSystem Organ Class: 10007541 - Cardiac disordersTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2015-001000-58-ES
- Lead Sponsor
- Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- 378
?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
?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] <30 mL/min/1.73 m2), presence of CMR contraindicated implanted devices (e.g., pacemaker, implanted cardiac defibrillator, cardiac resynchronization therapy device, cochlear implant), embedded metal objects (e.g., shrapnel), or any other contraindication for CMR.
?Assumed life expectancy < 1 year e.g. due to non-cardiac disease.
?TIMI flow grade > 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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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.<br>?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).<br>?To evaluate the effect of the study treatments on the frequency of MACE. <br>?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 Outcome Measures
Name Time Method 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.<br>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.<br>c) Markers of successful myocardial reperfusion: ST-segment resolution 90 minutes post-pPCI , TIMI flow and frame-count post-pPCI , and TIMI blush grade . <br>d) LV end-diastolic volume and LVEF, as determined by CMRI.<br>e) Volume of myocardium with MVO determined by late gadolinium enhancement expressed as percent of infarct size.<br>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