NCT03306303

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,700

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2014

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2017

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

October 2, 2017

Completed
9 days until next milestone

First Posted

Study publicly available on registry

October 11, 2017

Completed
Last Updated

October 11, 2017

Status Verified

October 1, 2017

Enrollment Period

3.8 years

First QC Date

October 2, 2017

Last Update Submit

October 4, 2017

Conditions

ST-segment Elevation Myocardial Infarction

Keywords

melatoninSTEMINo-reflow

Outcome Measures

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

    mediately after percutaneous coronary intervention (PCI)

Secondary Outcomes (2)

  • in-hospital complications

    up to 2 weeks after PCI

  • in-hospital major adverse cardiac or cerebrovascular events

    up to 2 weeks after PCI

Study Arms (4)

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

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability 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.

You may qualify if:

  • a diagnosis of STEMI and needed PCI

You may not qualify if:

  • patients with cancer patients who used melatonin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related 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.

    PMID: 22537272BACKGROUND

  • 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.

    PMID: 24768380BACKGROUND

  • 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.

    PMID: 15978056BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

melatonin, high-sensitivity C-reactive protein (hsCRP), superoxide dismutase levels

MeSH Terms

Conditions

ST Elevation Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

October 2, 2017

First Posted

October 11, 2017

Study Start

January 1, 2014

Primary Completion

October 1, 2017

Study Completion

October 1, 2017

Last Updated

October 11, 2017

Record last verified: 2017-10

Data Sharing

IPD Sharing
Will not share