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CompletedNCT03306303Updated Oct 11, 2017

Association Between Plasma Melatonin and No-reflow

An observational study in ST-segment Elevation Myocardial Infarction, sponsored by Chinese PLA General Hospital. Completed. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2017-10-11.

Sponsored by Chinese PLA General Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
1,700
Ages
18 Years to 80 Years
Sex
All
01

Study 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.

02

Conditions studied

  • ST-segment Elevation Myocardial Infarction

Keywords

  • melatonin
  • STEMI
  • No-reflow
03

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

PLA general hospital (PLAGH) is a large national tertiary-care center in the Beijing, China. The investigators enrolled all patients consecutively hospitalized in PLAGH, with a diagnosis of STEMI and needed PCI.

Inclusion criteria

a diagnosis of STEMI and needed PCI

Exclusion criteria

Exclusion Criteria:

patients with cancer patients who used melatonin

04

Study design

Observational model
Cohort
Time perspective
Other
Enrollment
1,700 participants (actual)
Patient registry
No
Biospecimen retention
Samples without dna

Groups and cohorts

  • Quartile 1 of plasma melatonin

    Quartile 1 of plasma melatonin

  • Quartile 2 of plasma melatonin

    Quartile 2 of plasma melatonin

  • Quartile 3 of plasma melatonin

    Quartile 3 of plasma melatonin

  • Quartile 4 of plasma melatonin

    Quartile 4 of plasma melatonin

05

What researchers measure

Primary outcomes

  1. 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

    Time frame: mediately after percutaneous coronary intervention (PCI)

Secondary outcomes

  1. 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

    Time frame: up to 2 weeks after PCI

  2. in-hospital major adverse cardiac or cerebrovascular events

    the composite of death, nonfatal MI, or stroke

    Time frame: up to 2 weeks after PCI

06

Study locations

No study locations are listed for this record.

07

References and documents

Publications

  • 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. PubMed 22537272 ↗
  • 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. No abstract available. PubMed 24768380 ↗
  • 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. doi: 10.1111/j.1600-079X.2005.00213.x. PubMed 15978056 ↗

Individual participant data

Plan to share: No

08

Registry details

Key details

Study ID
NCT03306303
Lead sponsor
Chinese PLA General Hospital
Responsible party
Chen Wei Ren, MD (Doctor, Chinese PLA General Hospital) — Principal investigator
First posted
Oct 11, 2017
Start date
Jan 1, 2014
Primary completion
Oct 1, 2017
Completion
Oct 1, 2017
Last update
Oct 11, 2017

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Oct 2017. You cannot join it, but the record below documents what was studied.

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