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Association Between Plasma Melatonin and No-reflow

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ClinicalTrials.gov Identifier: NCT03306303
Recruitment Status : Completed
First Posted : October 11, 2017
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Chen Wei Ren, MD, Chinese PLA General Hospital

Study Description
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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.

Condition or disease
ST-segment Elevation Myocardial Infarction

Study Design
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Study Type : Observational
Actual Enrollment : 1700 participants
Observational Model: Cohort
Time Perspective: Other
Official Title: Association Between Plasma Melatonin and No-reflow
Actual Study Start Date : January 1, 2014
Actual Primary Completion Date : October 1, 2017
Actual Study Completion Date : October 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Attack
Drug Information available for: Melatonin

Groups and Cohorts
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Group/Cohort
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


Outcome Measures
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Primary Outcome Measures :
  1. a change in the prevalence of no-reflow [ Time Frame: mediately after percutaneous coronary intervention (PCI) ]
    Thrombolysis in myocardial infarction (TIMI) flow grade of <3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow


Secondary Outcome Measures :
  1. in-hospital complications [ Time Frame: up to 2 weeks after PCI ]
    defined as acute heart failure, atrial fibrillation, chest pain or recurrence of myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia

  2. in-hospital major adverse cardiac or cerebrovascular events [ Time Frame: up to 2 weeks after PCI ]
    the composite of death, nonfatal MI, or stroke


Biospecimen Retention:   Samples Without DNA
melatonin, high-sensitivity C-reactive protein (hsCRP), superoxide dismutase levels

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   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.
Criteria

Inclusion Criteria:

a diagnosis of STEMI and needed PCI

Exclusion Criteria:

patients with cancer patients who used melatonin

Contacts and Locations
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

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Responsible Party: Chen Wei Ren, MD, Doctor, Chinese PLA General Hospital
ClinicalTrials.gov Identifier: NCT03306303    
Other Study ID Numbers: MelandNR
First Posted: October 11, 2017    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Chen Wei Ren, MD, Chinese PLA General Hospital:
melatonin
STEMI
No-reflow
Additional relevant MeSH terms:
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Myocardial Infarction
ST Elevation Myocardial Infarction
Infarction
Ischemia
Pathologic Processes
 Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases