Effect of Additional Treatment With EXenatide in Patients With an Acute Myocardial Infarction (the EXAMI Trial)
NCT ID: NCT01254123
Last Updated: 2010-12-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE3
40 participants
INTERVENTIONAL
2009-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
A total of 40 patients will be included in this single centre prospective randomised placebo controlled two-arm pilot study. Patients who are to undergo a primary PCI for a first acute ST elevation myocardial infarction are randomly assigned to placebo or Exenatide 5ug bolus in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours for 72 hours. Blood samples are obtained for assessment of enzymatic infarct size and Exenatide levels. Side effects of Exenatide are stringently monitored. Cardiac function will be measured using Cardiac Magnetic Resonance Imaging (CMRI) and 3D echocardiography at 1 week and 4 months post MI. Infarct size will be assessed by means of the final infarct size at 4 months post MI as a percentage of the area at risk at 1 week post MI. Furthermore we will compare the RNA profile of both groups.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Exenatide
Exenatide infusion
On arrival to our cardiac care unit (CCU) and after informed consent patients will be randomized to Exenatide infusion or Placebo infusion. Patients in the Exenatide group will immediately be treated be with Exenatide iv, 5ug bolus in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours.
Exenatide preparation: Byetta injection pens containing 1,2 ml (concentration 0,25 mg/ml; 60 doses of 5 μg) will be obtained. 3 doses (15 μg) will be diluted in 49 ml saline and 1 ml Human Serum Albumen (Cealb 200g/L, 10ml) to get a total of 50 ml containing 15 μg exenatide (or 300 ng exenatide / ml). A 50cc syringe will be placed in a pump system that is connected with a cannula in the patient's vein. The infusionrate will be 33,3 ml/hr for the first 30 minutes, followed by an infusion rate of 2,8 ml/hr for 72 hours. New 50cc syringes will be made every 8 hours.
Placebo
Placebo infusion.
On arrival to our cardiac care unit (CCU) and after informed consent patients will be randomized to Exenatide infusion or Placebo infusion. Patients in the placebo group will immediately be treated with placebo infusion.
Placebo preparation: 49ml saline and 1ml Human Serum Albumen (Cealb 200g/L, 10ml) to get a total of 50 ml will be placed in a 50cc syringe and placed in a pump system that is connected with a cannula in the patient's vein. The infusionrate will be 33,3 ml/hr for the first 30 minutes, followed by an infusion rate of 2,8 ml/hr for 72 hours. New 50cc syringes will be made every 8 hours.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Exenatide infusion
On arrival to our cardiac care unit (CCU) and after informed consent patients will be randomized to Exenatide infusion or Placebo infusion. Patients in the Exenatide group will immediately be treated be with Exenatide iv, 5ug bolus in 30 minutes, followed by a continuous Exenatide infusion of 20ug/ 24 hours.
Exenatide preparation: Byetta injection pens containing 1,2 ml (concentration 0,25 mg/ml; 60 doses of 5 μg) will be obtained. 3 doses (15 μg) will be diluted in 49 ml saline and 1 ml Human Serum Albumen (Cealb 200g/L, 10ml) to get a total of 50 ml containing 15 μg exenatide (or 300 ng exenatide / ml). A 50cc syringe will be placed in a pump system that is connected with a cannula in the patient's vein. The infusionrate will be 33,3 ml/hr for the first 30 minutes, followed by an infusion rate of 2,8 ml/hr for 72 hours. New 50cc syringes will be made every 8 hours.
Placebo infusion.
On arrival to our cardiac care unit (CCU) and after informed consent patients will be randomized to Exenatide infusion or Placebo infusion. Patients in the placebo group will immediately be treated with placebo infusion.
Placebo preparation: 49ml saline and 1ml Human Serum Albumen (Cealb 200g/L, 10ml) to get a total of 50 ml will be placed in a 50cc syringe and placed in a pump system that is connected with a cannula in the patient's vein. The infusionrate will be 33,3 ml/hr for the first 30 minutes, followed by an infusion rate of 2,8 ml/hr for 72 hours. New 50cc syringes will be made every 8 hours.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 Criteria
* 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
18 Years
80 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Amsterdam UMC, location VUmc
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Yolande Appelman, Dr.
Role: PRINCIPAL_INVESTIGATOR
Dept. of Cardiology VU Medical Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
VU Medical Center
Amsterdam, , Netherlands
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Yolande Appelman, Dr.
Role: primary
References
Explore related publications, articles, or registry entries linked to this study.
Huang M, Wei R, Wang Y, Su T, Li Q, Yang X, Chen X. Protective effect of glucagon-like peptide-1 agents on reperfusion injury for acute myocardial infarction: a meta-analysis of randomized controlled trials. Ann Med. 2017 Nov;49(7):552-561. doi: 10.1080/07853890.2017.1306653. Epub 2017 Mar 31.
Scholte M, Timmers L, Bernink FJ, Denham RN, Beek AM, Kamp O, Diamant M, Horrevoets AJ, Niessen HW, Chen WJ, van Rossum AC, van Royen N, Doevendans PA, Appelman Y. Effect of additional treatment with EXenatide in patients with an Acute Myocardial Infarction (EXAMI): study protocol for a randomized controlled trial. Trials. 2011 Nov 8;12:240. doi: 10.1186/1745-6215-12-240.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NL28593.029.09
Identifier Type: -
Identifier Source: org_study_id