Effect of additional treatment with exenatide in patients with an acute myocardial infarction: the EXAMI trial)

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 40

Inclusion Criteria

- >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)
- Time from onset of complaints at least 2 hours at presentation.
- Delay between onset of sustained chestpain and PCI < 6 hours.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

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

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

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