Role of Exosomes Derived From Epicardial Fat in Atrial Fibrillation
1 other identifier
interventional
35
1 country
1
Brief Summary
Exosome plays an important role in the pathophysiology of the cardiovascular system. Since the field of cardiovascular exosome is still in its infancy, there are no available data regarding to its role in cardiac arrhythmias. The current study investigates the role of epicardial fat derived exosomes in patients who suffer from atrial fibrillation.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable atrial-fibrillation
Started Jan 2018
Typical duration for not_applicable atrial-fibrillation
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 21, 2018
CompletedFirst Submitted
Initial submission to the registry
March 20, 2018
CompletedFirst Posted
Study publicly available on registry
March 27, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 21, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
January 21, 2022
CompletedApril 8, 2021
April 1, 2021
4 years
March 20, 2018
April 6, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Exosomes quantity excreted from the epicardial fat (nm)
The differences in the quantity of exosomes derived epicardial fat in patients with and without atrial fibrillation. The exosome isolation will be done by using ultra centrifuge for cells and cells debris removal. Then the exosomes will examined by the Malvern NanoSight device both for particle size and concentration measurement.
9 days
Secondary Outcomes (1)
Inflammatory cytokines secretion from epicardial fat
9 days
Study Arms (2)
Atrial fibrillation
OTHERAn epicardial fat biopsy will be taken from patients with chronic atrial fibrillation or paroxysmal atrial fibrillation who undergo any cardiac surgery
Control
OTHERAn epicardial fat biopsy will be taken from patients without any history of atrial fibrillation who undergo any cardiac surgery
Interventions
A 1 cm (\~0.5 g) of epicardial pat biopsy from the area of the pulmonary artery
Eligibility Criteria
You may qualify if:
- Age ≥ 18 years
- Undergoing an elective cardiac surgery
You may not qualify if:
- Undergoing a non-elective surgery
- Suffering from severe renal impairment prior to surgery (creatinine clearance \<30 mL/min)
- Experienced hepatic dysfunction other than mild
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sheba medical center
Ramat Gan, 52621, Israel
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eilon Ram, MD
Sheba Medical Center
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER GOV
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Resident in cardiac surgery, Principal Investigator
Study Record Dates
First Submitted
March 20, 2018
First Posted
March 27, 2018
Study Start
January 21, 2018
Primary Completion
January 21, 2022
Study Completion
January 21, 2022
Last Updated
April 8, 2021
Record last verified: 2021-04