Effects of Melatonin on Reperfusion Injury

Reperfusion Injury, Myocardial Clinical Trial

Official title:

Effects of Melatonin on Reperfusion Injury in Patients With ST-segment Elevation Myocardial Infarction Undergoing Primary Percutaneous Coronary Intervention

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03303378
• Other study ID #: MelonRI
• Status: Recruiting
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 4, 2017
• Start date: November 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: October 2017
• Source: Chinese PLA General Hospital
• Contact: wei ren chen, M.D.
• Phone: +8610-66876231
• Email: chen_weiren[@]sina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Acute myocardial infarction is a major cause of mortality and morbidity. Primary percutaneous coronary intervention (pPCI) is currently the most effective treatment strategy in acute myocardial infarction. However, a sizable number of patients fail to restore optimal myocardial reperfusion, mostly because of the 'no-reflow' phenomenon. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Several studies have shown that melatonin protects against ischemia/reperfusion injury (IRI). In our previous study, melatonin markedly reduced infarcted area, improved cardiac function and reduced lactate dehydrogenase release in rats. The investigators planned to research the cardioprotective effects of intravenous melatonin administered prior to reperfusion and continued after restoration of coronary blood flow in patients with ST segment elevation myocardial infarction undergoing pPCI.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 190
• Est. completion date: November 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

ST segment elevation myocardial infarction undergoing primary percutaneous poronary intervention

Exclusion Criteria:

• unconscious at presentation

• had cardiogenic shock

• had a history of myocardial infarction

• stent thrombosis

• renal insufficiency

• had previously undergone coronary artery bypass surgery

Related Conditions & MeSH terms

• Myocardial Infarction
• Myocardial Reperfusion Injury
• Reperfusion Injury
• Reperfusion Injury, Myocardial
• Wounds and Injuries

Intervention

Drug:
• melatonin (Helsinn Chemical Co, Biasca, Switzerland)
Patients will receive a total intravenous melatonin (Helsinn Chemical Co, Biasca, Switzerland) dose of 11.61 mg (aproximately 166 µg/kg). The dose will be distributed in a volume of 500 ml of an isotonic and sterile solution of 100 µM melatonin during 150 min with a drip rate of 4.2 ml/min. The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).
• Placebos
The temporal distribution of perfusion will be: 30 min previous to percutaneous revascularization and remainder doses in a subsequent 120 min (1 h during the angioplasty +60 min post-intervention).

Locations

Country	Name	City	State
China	PLA General Hospital	Beijing	Beijing

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

Country where clinical trial is conducted

China, 

References & Publications (3)

Dominguez-Rodriguez A, Abreu-Gonzalez P, de la Torre-Hernandez JM, Consuegra-Sanchez L, Piccolo R, Gonzalez-Gonzalez J, Garcia-Camarero T, Del Mar Garcia-Saiz M, Aldea-Perona A, Reiter RJ; MARIA Investigators. Usefulness of Early Treatment With Melatonin — View Citation

Dominguez-Rodriguez A, Abreu-Gonzalez P, Garcia-Gonzalez MJ, Kaski JC, Reiter RJ, Jimenez-Sosa A. A unicenter, randomized, double-blind, parallel-group, placebo-controlled study of Melatonin as an Adjunct in patients with acute myocaRdial Infarction under — View Citation

Zhou H, Zhang Y, Hu S, Shi C, Zhu P, Ma Q, Jin Q, Cao F, Tian F, Chen Y. Melatonin protects cardiac microvasculature against ischemia/reperfusion injury via suppression of mitochondrial fission-VDAC1-HK2-mPTP-mitophagy axis. J Pineal Res. 2017 Aug;63(1). — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The salvage index	The salvage index measured by cardiac magnetic resonance	3 months after primary percutaneous coronary intervention
Secondary	The final infarct size	The final infarct size measured by cardiac magnetic resonance	3 months after primary percutaneous coronary intervention
Secondary	major adverse cardiovascular events (MACE)	recurrent myocardial infarction, recurrent angina, revascularization, heart failure, cardiac death.	3 months after primary percutaneous coronary intervention
Secondary	treatment-emergent adverse events (TEAEs)	hypoglycemia, nausea	3 months after primary percutaneous coronary intervention