Status:
UNKNOWN
Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)
Lead Sponsor:
Amsterdam UMC, location VUmc
Conditions:
Patients With a First Acute Myocardial Infarction to be Treated With Primary Percutaneous Coronary Intervention (PCI).
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
Myocardial infarction (MI) causes loss of myocytes and may lead to loss of ventricular function, morbidity and mortality. The most effective therapy is early reperfusion of the ischemic myocardium by ...
Eligibility Criteria
Inclusion
- \>18 and \< 80 years of age
- First myocardial infarction
- ST elevation of more than one mm in at least 2 separate leads on the electrocardiogram (ECG)
- Delay between onset of sustained chestpain and PCI \< 6 hours.
Exclusion
- 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 \< 30ml/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
Key Trial Info
Start Date :
November 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT01254123
Start Date
November 1 2009
Last Update
December 6 2010
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
VU Medical Center
Amsterdam, Netherlands, 1081 HV