Intracoronary and systemic melatonin to patients with acute myocardial infarction: protocol for the IMPACT trial.
BACKGROUND
Ischaemia-reperfusion injury following acute myocardial infarctions (AMI) is an unavoidable consequence of the primary percutaneous coronary intervention (pPCI) procedure. A pivotal mechanism in ischaemia-reperfusion injury is the production of reactive oxygen species following reperfusion. The endogenous hormone, melatonin, works as an antioxidant and could potentially minimise the ischaemia-reperfusion injury. Given intracoronarily, it enables melatonin to work directly at the site of reperfusion. We wish to test if melatonin, as an antioxidant, can minimise the reperfusion injury following pPCI in patients with AMI.


METHODS
The IMPACT trial is a multicentre, randomised, double-blinded, placebo-controlled study. We wish to include 2 × 20 patients with ST-elevation myocardial infarctions undergoing pPCI within six hours from symptom onset. The primary end-point is the Myocardial Salvage Index assessed by cardiovascular magnetic resonance imaging on day 4 (± 1) after pPCI. The secondary end-points are high-sensitivity troponin, creatinekinase myocardial band and clinical events.


CONCLUSIONS
The aim of the IMPACT trial is to evaluate the effect of melatonin on reperfusion injuries following pPCI. Owing to its relatively non-toxic profile, melatonin is an easily implementable drug in the clinical setting, and melatonin has the potential to reduce morbidity in patients with AMI.


BACKGROUND
This study received no financial support from the industry.


BACKGROUND
www.clinicaltrials.gov, clinical trials identifier: NCT01172171.
Department of Surgery, Herlev Hospital, Herlev Ringvej 75, 2730 Herlev, Denmark. nathoel@yahoo.dk.
Natalie L
NL
Halladin
Sarah Ekeløf
SE
Busch
Svend Eggert
SE
Jensen
Henrik Steen
HS
Hansen
Tomas
T
Zaremba
Jens
J
Aarøe
Jacob
J
Rosenberg
Ismail
I
Gögenur
D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000975:Antioxidants / Q000627:therapeutic use*; D002985:Clinical Protocols; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007275:Injections, Intravenous; D008297:Male; D008550:Melatonin / Q000627:therapeutic use*; D008875:Middle Aged; D009203:Myocardial Infarction / Q000150:complications* / Q000628:therapy; D062645:Percutaneous Coronary Intervention; D015427:Reperfusion Injury / Q000209:etiology / Q000517:prevention & control*; D012107:Research Design; D016896:Treatment Outcome; D055815:Young Adult
D000975:Antioxidants; D008550:Melatonin