Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:19 PM
Ignite Modification Date:
2025-12-24 @ 10:19 PM
NCT ID:
NCT01938235
Eligibility Criteria:
Inclusion Criteria:
* Admission for primary PCI for STEMI, with enrollment within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥1mm in 2 or more limb leads, or ≥2mm in 2 or more precordial leads, or new onset LBBB) associated with acute chest pain or an elevation of cardiac enzymes.
* Antegrade TIMI 0 or 1 prior to PCI in the infarct-related artery
* Age ≥18 years
Exclusion Criteria:
* Symptomatic hypoglycemia (serum glucose \<3.3 µmol/L; 60 mg/dl)
* Diabetes mellitus requiring insulin therapy
* Diabetic ketoacidosis
* Coronary anatomy warranting emergent coronary artery bypass graft surgery
* Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation)
* Need for hemodialysis
* Malignancy, HIV, or central nervous system disorder
* Cardiopulmonary resuscitation \>15 min and compromised level of consciousness.
* Cardiogenic shock
* Current participation in any research study involving investigational drugs or devices
* Inability to give informed consent
* Inability to safely undergo cMRI (presence of cardiac pacemaker, implanted cardiac defibrillator, aneurysm clips, carotid artery vascular clamp, neurostimulator, implanted drug infusion device, bone growth/fusion stimulator, cochlear, otologic, or ear implant, severe claustrophobia)
* Women of childbearing potential who are known to be pregnant or lactating or who have a positive pregnancy test on admission
* History of pancreatitis
* Known end stage renal failure or known eGFR \<30 mL/min
* Currently taking exenatide (Byetta, Bydureon), liraglutide (Victoza), or any other GLP-1 agonist
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01938235
Study Brief:
Protocol Section:
NCT01938235