Ignite Creation Date:
2025-12-24 @ 7:47 PM
Ignite Modification Date:
2026-01-06 @ 4:26 AM
Study NCT ID:
NCT03306303
Status:
COMPLETED
Last Update Posted:
2017-10-11
First Post:
2017-10-02
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Association Between Plasma Melatonin and No-reflow
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000072657', 'term': 'ST Elevation Myocardial Infarction'}], 'ancestors': [{'id': 'D009203', 'term': 'Myocardial Infarction'}, {'id': 'D017202', 'term': 'Myocardial Ischemia'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D007238', 'term': 'Infarction'}, {'id': 'D007511', 'term': 'Ischemia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009336', 'term': 'Necrosis'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'melatonin, high-sensitivity C-reactive protein (hsCRP), superoxide dismutase levels'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 1700}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2014-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-10', 'completionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-10-04', 'studyFirstSubmitDate': '2017-10-02', 'studyFirstSubmitQcDate': '2017-10-04', 'lastUpdatePostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'a change in the prevalence of no-reflow', 'timeFrame': 'mediately after percutaneous coronary intervention (PCI)', 'description': 'Thrombolysis in myocardial infarction (TIMI) flow grade of \\<3 with a myocardial blush grade of 0-1 was defined as angiographic no-reflow'}], 'secondaryOutcomes': [{'measure': 'in-hospital complications', 'timeFrame': 'up to 2 weeks after PCI', 'description': 'defined as acute heart failure, atrial fibrillation, chest pain or recurrence of myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia'}, {'measure': 'in-hospital major adverse cardiac or cerebrovascular events', 'timeFrame': 'up to 2 weeks after PCI', 'description': 'the composite of death, nonfatal MI, or stroke'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['melatonin', 'STEMI', 'No-reflow'], 'conditions': ['ST-segment Elevation Myocardial Infarction']}, 'referencesModule': {'references': [{'pmid': '22537272', 'type': 'BACKGROUND', 'citation': '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': '24768380', 'type': 'BACKGROUND', '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. No abstract available.'}, {'pmid': '15978056', 'type': 'BACKGROUND', '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. doi: 10.1111/j.1600-079X.2005.00213.x.'}]}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\na diagnosis of STEMI and needed PCI\n\nExclusion Criteria:\n\npatients with cancer patients who used melatonin'}, 'identificationModule': {'nctId': 'NCT03306303', 'briefTitle': 'Association Between Plasma Melatonin and No-reflow', 'organization': {'class': 'OTHER', 'fullName': 'Chinese PLA General Hospital'}, 'officialTitle': 'Association Between Plasma Melatonin and No-reflow', 'orgStudyIdInfo': {'id': 'MelandNR'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Quartile 1 of plasma melatonin', 'description': 'Quartile 1 of plasma melatonin'}, {'label': 'Quartile 2 of plasma melatonin', 'description': 'Quartile 2 of plasma melatonin'}, {'label': 'Quartile 3 of plasma melatonin', 'description': 'Quartile 3 of plasma melatonin'}, {'label': 'Quartile 4 of plasma melatonin', 'description': 'Quartile 4 of plasma melatonin'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Chinese PLA General Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Doctor', 'investigatorFullName': 'Chen Wei Ren, MD', 'investigatorAffiliation': 'Chinese PLA General Hospital'}}}}