NCT03592732

Brief Summary

The principal aim of the present study is to analyze adiponectin, omentin-1, apelin and visfatin plasma levels in patients with and without AF in an effort to identify their potential role in the development of AF.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 29, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 28, 2018

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 19, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 29, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 29, 2021

Completed
Last Updated

February 1, 2021

Status Verified

January 1, 2021

Enrollment Period

2.8 years

First QC Date

June 28, 2018

Last Update Submit

January 29, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • adiponectin, omentin-1, apelin and visfatin plasma levels

    adiponectin, omentin-1, apelin and visfatin plasma levels calculation by the Eliza method

    blood sample collection analysis (day zero

Study Arms (2)

A

Patients with atrial fibrillation

Other: Blood sample

B

Patients without atrial fibrillation

Other: Blood sample

Interventions

Blood sample

AB

Eligibility Criteria

AgeUp to 85 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All participants will undergo either electrocardiogram or 24-hour Holter monitoring. AF patients will be divided into the following three groups: paroxysmal AF, persistent AF and permanent AF.Blood samples will be collected after 12-hour overnight fasting. Plasma adiponectin, omentin-1, apelin and visfatin levels will be measured by the Elisa method. Natriuretic peptide, C-reactive protein (CRP) and parameters concerning lipid profile (total cholesterol, triglycerides, low-density cholesterol, high-density cholesterol), glycemic profile (plasma glucose, hemoglobin A1c) and renal function (urea, creatinine) will be measured by standardized enzymatic methods as well. Transthoracic echocardiography will be performed in every patient.

You may qualify if:

  • healthy subjects without atrial fibrillation and subjects with paroxysmal, persistent or permanent atrial fibrillation

You may not qualify if:

  • Patients with coronary artery disease, acute coronary syndrome, heart failure (EF\<50%), cardiomyopathy, cancer, significant valvular disease, rheumatic heart disease, chronic kidney disease (eGRF\<30) or stroke will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

LAIKO General Hospital, Athens, Greece

Athens, 11522, Greece

RECRUITING

MeSH Terms

Conditions

Atrial FibrillationObesityObesity, AbdominalEndocrine System Diseases

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and Symptoms

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Elias Sanidas, MD, PhD

    Dept. of Cardiology, ESH Excellence Center, LAIKO General Hospital, Athens, Greece

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Maria Velliou, MD

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

June 28, 2018

First Posted

July 19, 2018

Study Start

March 29, 2018

Primary Completion

January 29, 2021

Study Completion

January 29, 2021

Last Updated

February 1, 2021

Record last verified: 2021-01

Locations