Epicardial Fat in Cardiovascular Diseases

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Gianluca Iacobellis，University of Miami

Tracking Information

First Submitted Date ^ICMJE

September 30, 2018

First Posted Date ^ICMJE

October 2, 2018

Last Update Posted Date

October 3, 2018

Actual Study Start Date ^ICMJE

September 1, 2018

Estimated Primary Completion Date

December 31, 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

EAT pro-arrhythmogenic genes[ Time Frame: 24 hours ]

Differences in pro-arrhythmogenic transcriptome between peri-atrial EAT, peri coronary EAT and SAT in patients with and without AF

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

EAT thermoregulatory genes[ Time Frame: 24 hours ]
Differences in peri-coronary EAT thermoregulatory transcriptome in patients with and without CAD

Descriptive Information

Brief Title ^ICMJE

Epicardial Fat in Cardiovascular Diseases

Official Title ^ICMJE

Epicardial Fat as Brown and Arrhythmogenic Fat in Coronary Artery Disease

Brief Summary

Epicardial adipose tissue (EAT) is the visceral fat depot of the heart. EAT transcriptome is unique when compared to subcutaneous fat. EAT is a highly inflammatory tissue enriched with genes involved in inflammation, endothelial function, immune signaling and thermoregulation. EAT has been correlated with coronary artery disease (CAD) and atrial fibrillation (AF), although the mechanisms of the interplay of EAT with these two major cardiovascular diseases have not been fully understood. Whether EAT may act as brown fat and whether this may be affected by the presence of CAD is currently unknown. Whether the postulated thermoregulatory function of the EAT is correlated to the presence and severity of CAD is unknown EAT is though to play a role in the development and recurrence of AF. Recent studies showed that EAT has a unique transcriptome with genes encoding for pro-arrhythmogenic proteins. EAT is located in different areas of the heart. Whether regional EAT depots may have different genetic profile and functions is unknown. Whether peri-atrial EAT may have unique effects on cardiac muscle activity distinct from other EAT sub-depots is unknown. Peri left atrial EAT and pericoronary EAT will be collected from patients who are undergoing elective cardiac surgery as standard care. EAT transcriptome will be analysed with RNA- sequencing analysis (RNA-seq) and quantitative real time polymerase chain reaction (qRT-PCR) . Immunofluorescence and immunoblot will be also performed on fat samples.

Detailed Description

Study Type ^ICMJE

Observational

Study Phase

Study Design ^ICMJE

Allocation:
Intervention Model:
Intervention Model Description:
Masking: Observational
Masking Description:
Primary Purpose:

Condition ^ICMJE

Intervention ^ICMJE

Procedure: Coronary artery bypass grafting (CABG)
CABG, as part of the standard medical care
Procedure: Valve replacement
cardiac surgery for aortic or mitral valve replacement as part of their standard medical care

Study Arms

: AF + CAD
Patients with clinically and angiographically established CAD and Atrial Fibrillation (AF) who require CABG, as part of the standard medical care
: (no AF + CAD)
Patients with clinically and angiographically established CAD without AF who require CABG, as part of the standard medical care
: Control (no CAD, no AF)
subjects who have no history, clinical signs of either CAD or AF, randomly selected, who will undergo cardiac surgery for aortic or mitral valve replacement as part of their standard medical care

Recruitment Information

Recruitment Status ^ICMJE

Recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

June 30, 2020

Estimated Primary Completion Date

December 31, 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria: - Patients with paroxysmal or persistent AF (Group 1). Paroxysmal AF is defined per the guidelines as recurrent AF (2 episodes) that terminates spontaneously within 7 days. Persistent AF is defined per the guidelines as continuous AF that is sustained beyond 7 days (or AF in which a decision is made to cardiovert the patient after ≥48 hours of AF, but prior to 7 days). - Patients with clinically and angiographically established CAD who require CABG, as part of the standard medical care (Group 1 and 2); - age > 18 years old; - absence of signs and history of CAD in the control group. The absence or presence of CAD will be determined by the cardiologists and cardiac surgeons based on clinical history, pre-operative coronary angiography and other routine tests (All groups). Exclusion Criteria: - Acute or chronic infective diseases; - cancer or chemotherapy; - history of pulmonary, (pulmonary embolism, etc) renal or liver diseases, - hypo- and hyperthyroidism, - drug abuse; - patients with a life expectancy <1 year - Pregnant or breast-feeding women

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

Gianluca Iacobellis，University of Miami

Study Sponsor ^ICMJE

University of Miami

Collaborators ^ICMJE

Investigators ^ICMJE

PRS Account

University of Miami

Verification Date

September 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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