Acute Myocardial Infartion to be treated with primary PCI MedDRA version: 12.0 Level: LLT Classification code 10000891 Term: Acute myocardial infarction
Conditions
Interventions
Trade Name: Byetta
Pharmaceutical Form: Solution for injection
INN or Proposed INN: EXENATIDE
CAS Number: 141758-74-9
Other descriptive name: Exenatide
Concentration unit: µg microgram(s)
Concentratio
Sponsors
VU University Medical Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - >18 and =65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: - Cardiac rhythm is other than normal sinus rhythm. - Patient in Killip class 3 or 4 of heart failure - Cardiogenic shock defined as sustained systolic blood pressure = 80mmHg despite fluid hydration. - Post cardiac resuscitation - Need for intra aortic balloon counterpulsation therapy - The patient is unable to hold his/her breath for up to 20 seconds due to age or concomitant illness - No former PCI performed - No recanalisation achieved of the occluded coronary artery - Culprit not in segment 1,2,3,6,7,11,12,13 of the coronary artery - No definite culprit - More than one occluded vessel, or a more than 70% stenosis by visual assessment in a non-culprit vessel. - TIMI 3 flow in culprit lesion at presentation - Decreased renal function eGFR < 50ml/min - Any contraindication for MRI ie: implanted electronic devices such as pacemakers, internal defibrillators, neurostimulators, implanted drug infusion devices, cochlear implants, cerebrovascular clips, claustrophobia. previous vascular surgery: aneurysm clip, carotid artery vascular clamp, aortic clips, venous umbrella spinal/intra-ventricular shunts - Metal fragments in eye, head, ear, skin or shoulder. - Swann-Ganz catheter. - Known pre-existing left ventricular dysfunction measured by any technique (ejection fraction < 45% prior to current admission for myocardial infarction) - Prior myocardial infarction - Prior coronary artery bypass grafting - Moderate to severe cardiac valve disease - Stroke or transient ischemic attack within the previous 24 hours - Serious known concomitant disease with a life expectancy of less than one year - Follow up impossible - Previous participation in a trial within the previous 30 days - Known type I Diabetes Mellitus - Known type II Diabetes Mellitus - Pregnancy and/or lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Secondary Objective: -To assess feasibility of this pilot trial -To assess side effects of exenatide during acute myocardial infarction;Primary end point(s): Infarct size measured as the final infarct size on DE MRI at 4 months as a percentage of the area at risk on T2 weighed MRI at 3-5 days.;Main Objective: The primary objective is to determine whether additional treatment with exenatide in patients with acute myocardial infarction and treated with primary PCI, leads to a more preserved left ventricular function, compared to placebo in addition to primary PCI. Primairy endpoint: Infarct size measured as the final infarct size on Delayed Enhancement (DE) MRI at 4 months as a percentage of the area at risk on T2 weighed MRI at 3-5 days. | — |
Countries
Netherlands
Outcome results
None listed