COMBinAtion Therapy in Myocardial Infarction: The COMBAT-MI trial - The COMBAT-MI trial

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)0 个研究点目标入组 378 人开始时间: 2015年6月1日最近更新: 2022年4月19日

适应症

试验速览

暂无简介。

•?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

发起方

Fundació Hospital Universitari Vall d'Hebron - Institut de Recerca (VHIR)