Acute Myocardial Infarction Clinical Trial
Official title:
Intracoronary Injection of Melatonin for Patients With ST-elevation Myocardial Infarction: a Placebo Controlled Randomized Study
In Denmark, 12.000 people a year, is struck by acute myocardial infarction. A third of these
cannot be saved before treatment is possible.
Despite quick and effective reperfusion of the coronary arteries using PCI (Percutaneous
Coronary Intervention) after an acute ST-elevation myocardial infarction, substantial
morbidity and mortality remain. Infarct size is an important determinant of the short-and
long-term outcome after acute myocardial infarction. The most widely used and most effective
proven therapy to limit infarct size is the early reperfusion induced by or PCI.
Although beneficial in terms of myocardial salvage, reperfusion itself may contribute to
additional damage of the myocardium; the damage due to the combined processes is known as
"ischemia-reperfusion injury". The pathogenesis of myocardial ischemia-reperfusion injury is
a multifactorial process involving the interaction of multiple mechanisms. Numerous studies
indicate that there are three pivotal factors in the pathogenesis of ischemia-reperfusion
injury: elevated oxidative damage, depressed energy metabolism, and altered calcium
homeostasis.
Partially reduced species of oxygen, including the superoxide anion radical, hydroxyl
radical, and hydrogen peroxide, are generated intracellularly as by-product of oxygen
metabolism. These reactive oxygen species cause peroxidation af membrane lipids,
denaturation of proteins, and modification of DNA, all of which ultimately can lead to cell
death. In mammals, cell damage induced by partially reduced oxygen species can also initiate
local inflammatory responses, which then lead to further oxidant-mediated tissue injury.
Melatonin is mainly known for its role as an endogenously produced circadian hormone.
For the last twenty years, increasing evidence has proven melatonin to be a very potent
direct and indirect antioxidant.
Recent experimental studies have documented the beneficial effects of melatonin in reducing
tissue damage and limiting cardiac pathophysiology in models of experimental
ischemia-reperfusion.
Primary hypothesis: Melatonin given to patients undergoing PCI can reduce the myocardial
damage sustained by ischemia-reperfusion.
Status | Completed |
Enrollment | 41 |
Est. completion date | December 2016 |
Est. primary completion date | June 2016 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years and older |
Eligibility |
Inclusion criteria: - Adults who are able to give informed consent - 1 significant coronary occlusion (>2mm) with TIMI 0-1 expected to undergo PCI. - The occlusion must be ECG-verified with new ST-elevations = 0.2 mV in V2-V3 and/or = 0.1 in the other leads or a new onset left bundle branch block. - Having onset of symptoms of qualifying AMI and undergo PCI within 6 hours. - If the patients do not fulfill the ECG inclusion criteria they can still be included if the primary PCI reveals an acute coronary occlusion (>2mm) with TIMI 0-1. Exclusion criteria: - Patients with prior myocardial infarction - more than one significant occlusion - prehospital thrombolysis - known history of renal failure - history of autoimmune diseases - pregnancy, fertile women or breastfeeding - severe concurrent illness with reduced short-term prognosis - pacemaker - claustrophobia - cardiogenic shock - metals in the body - atrial fibrillation - BMI = 40. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Denmark | Aalborg University Hospital | Aalborg | |
Denmark | Odense University Hospital | Odense |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | MRI of the heart | Focusing on quantification infarct size, area at risk and myocardial salvage index | day 4 after pci (+/- 1 day) | No |
Secondary | Creatinin Kinase Myocardial Band (CK-MB) | CK-MB is a cardiac enzyme, which is elevated when the myocardium is damaged. | 96 Hours after pci | No |
Secondary | Clinical events | Death, sustained ventricular arrhythmias, resuscitation from cardiac arrest, cardiogenic shock, heart failure, major bleedings, stroke, need for revascularization, recurrent ischemia, re-infarctions and re-hospitalization. | Within 90 days of pci | No |
Secondary | High-sensitive Troponin T (Hs-TnT) or High-sensitive TnI | Troponin T/I is a cardiac enzyme, which rises when the myocardium is damaged. To determine whether melatonin treatment reduces infarct size as determined by the concentration of Troponin T/I (area under the curve) in the blood, it will be measured daily for the first 4 days after infarction. | 96 hours after pci | No |
Secondary | plasma level of melatonin | An assessment of the endogenous level of plasma melatonin | after pci | No |
Secondary | Oxidative markers in plasma | 24 hours after pci | No |
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