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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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16 December 2017 |
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Main ID: |
NCT03360981 |
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Date of registration:
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28/11/2017 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Epicardial Fat and Clinical Outcomes After Coronary Artery Bypass Grafting in Diabetics vs. Non Diabetics
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Scientific title:
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Epicardial Fat Evaluation to Predict Clinical Outcomes in Patients Affected by Coronary Artery Disease and Treated by Coronary Artery Bypass Grafting: Diabetic vs. Non Diabetic Patients, and Incretin Therapy Effect; The EPI.FAT.IN Study |
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Date of first enrolment:
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September 20, 2017 |
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Target sample size:
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150 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT03360981 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Single (Participant).
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Phase:
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Phase 4
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Countries of recruitment
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Italy
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Contacts
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Name:
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Raffaele R Marfella, MD, PhD |
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Address:
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Telephone:
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00390815665110 |
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Email:
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raffaele.marfella@unicampania.it |
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Affiliation:
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Name:
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Raffaele Marfella, MD, PhD |
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Address:
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Telephone:
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3336664543 |
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Email:
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raffaele.marfella@unicampania.it |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- patients aged >18, <75, left ventricle ejection fraction (LVEF) >50%, multivessel
coronary disease detected by coronarography, indication to receive a CABG, stable CAD.
All diabetics and non diabetics.
Exclusion Criteria:
- acute myocardial infarction, heart failure, neoplastic disease, chronic diseases that
may affect the inflammatory profile both systemic and epicardial (cancer, chronic
intestinal inflammation, hepatitis, AIDS); life expectancy < 6 months, previous CABG
and/or other open heart surgery intervention, acute coronary syndrome
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Diabetes
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Coronary Artery Disease
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Intervention(s)
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Drug: Incretins
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Primary Outcome(s)
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All cause mortality
[Time Frame: 12 months]
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cardiac mortality
[Time Frame: 12 months]
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Major adverse cardiac events (MACE)
[Time Frame: 12 months]
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Secondary Outcome(s)
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serum microRNAs and epicardial fat microRNAs,
[Time Frame: 12 months]
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molecular markers (Sirtuin 1, 6, etc) to predict study endpoints
[Time Frame: 12 months]
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stem cells isolated in epicardial fat.
[Time Frame: 12 months]
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Secondary ID(s)
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28.11.2017.1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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