Association Between Plasma Melatonin and No-reflow

ST-segment Elevation Myocardial Infarction Clinical Trial

Official title:

Association Between Plasma Melatonin and No-reflow

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03306303
• Other study ID #: MelandNR
• Status: Completed
• Phase: N/A
• First received: October 2, 2017
• Last updated: October 4, 2017
• Start date: January 1, 2014
• Est. completion date: October 1, 2017

Study information

• Verified date: October 2017
• Source: Chinese PLA General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

ST-segment elevation myocardial infarction (STEMI) is an acute manifestation of coronary heart disease, remaining a frequent cause of death. A better understanding of risk factors and pathogenic mechanisms underlying STEMI may help improve the prognosis and life quality of these patients. Melatonin is the chief indoleamine produced by the pineal gland, and a well-known antioxidant and free radical scavenger. Basic studies have showed that melatonin is associated with myocardial infarction and heart failure. However, no study has evaluated whether melatonin is associated with adverse clinical outcomes in STEMI patients.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1700
• Est. completion date: October 1, 2017
• Est. primary completion date: October 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

a diagnosis of STEMI and needed PCI

Exclusion Criteria:

patients with cancer patients who used melatonin

Related Conditions & MeSH terms

• Infarction
• Myocardial Infarction
• ST-segment Elevation Myocardial Infarction

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese PLA General Hospital

References & Publications (3)

Dominguez-Rodriguez A, Abreu-Gonzalez P, Arroyo-Ucar E, Reiter RJ. Decreased level of melatonin in serum predicts left ventricular remodelling after acute myocardial infarction. J Pineal Res. 2012 Oct;53(3):319-23. doi: 10.1111/j.1600-079X.2012.01001.x. Epub 2012 Apr 27. — View Citation

Dominguez-Rodriguez A, Abreu-Gonzalez P, Reiter RJ. The potential usefulness of serum melatonin level to predict heart failure in patients with hypertensive cardiomyopathy. Int J Cardiol. 2014 Jun 15;174(2):415-7. doi: 10.1016/j.ijcard.2014.04.044. Epub 2014 Apr 15. — View Citation

Tutuncu NB, Batur MK, Yildirir A, Tutuncu T, Deger A, Koray Z, Erbas B, Kabakci G, Aksoyek S, Erbas T. Melatonin levels decrease in type 2 diabetic patients with cardiac autonomic neuropathy. J Pineal Res. 2005 Aug;39(1):43-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a change in the prevalence of no-reflow	Thrombolysis in myocardial infarction (TIMI) flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow	mediately after percutaneous coronary intervention (PCI)
Secondary	in-hospital complications	defined as acute heart failure, atrial fibrillation, chest pain or recurrence of myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia	up to 2 weeks after PCI
Secondary	in-hospital major adverse cardiac or cerebrovascular events	the composite of death, nonfatal MI, or stroke	up to 2 weeks after PCI