NCT07467941

Brief Summary

Obesity has become a major public health problem in both developed and developing countries, with a continuous increase particularly since the 1980s. Moreover, it is a well-established metabolic risk factor for diabetes mellitus, hypertension, and various types of cancer, as well as cardiovascular diseases such as heart failure and coronary artery disease. Body mass index (BMI) is calculated by dividing body weight in kilograms by the square of height in meters and is widely used as an indicator of obesity. However, BMI does not quantitatively reflect body fat distribution and fails to account for components such as skeletal muscle and bone mass. Therefore, interest in assessing body fat distribution has increased, and in recent years, studies evaluating the correlation between anthropometric, biochemical, and anatomical measurements and clinical outcomes have become more frequent. In particular, it is acknowledged that abdominal obesity cannot be accurately represented by BMI alone and is primarily associated with visceral adipose tissue (VAT). The aim of this study is to evaluate the association between preoperative visceral and subcutaneous adipose tissue measurements (VAT and SAT), assessed by ultrasonography in patients scheduled for open-heart surgery, and the development of postoperative atrial fibrillation.

Trial Health

65
Monitor

Trial Health Score

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

Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
7mo left

Started Apr 2026

Shorter than P25 for all trials

Status
not yet recruiting

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 Progress25%
Apr 2026Jan 2027

First Submitted

Initial submission to the registry

March 8, 2026

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 12, 2026

Completed
20 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2026

Expected
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 22, 2027

Last Updated

March 12, 2026

Status Verified

March 1, 2026

Enrollment Period

9 months

First QC Date

March 8, 2026

Last Update Submit

March 8, 2026

Conditions

Keywords

Atrial Fibrillation (AF)Visceral Adipose TissueCABG

Outcome Measures

Primary Outcomes (1)

  • Effect of visceral adipose tissue thickness on postoperative atrial fibrillation

    Preoperative ultrasound-guided measurement of visceral adipose tissue thickness will be performed. The association between visceral fat thickness and the development of postoperative atrial fibrillation will be evaluated.

    Within 7 days after coronary artery bypass graft surgery or until hospital discharge

Study Arms (2)

Group 1: Postoperative AF Group

Visceral and subcutaneous adipose tissue thickness in patients who develop postoperative atrial fibrillation after coronary artery bypass graft surgery.

Other: Postoperative AF Group

Group 2: Non-AF Group

Visceral and subcutaneous adipose tissue thickness in patients who do not develop postoperative atrial fibrillation after coronary artery bypass graft surgery.

Other: Non-AF Group

Interventions

In patients undergoing coronary artery bypass graft surgery, ultrasound-guided measurements of visceral and subcutaneous adipose tissue will be performed preoperatively. The relationship between adipose tissue thickness and the development of postoperative atrial fibrillation will be evaluated by comparing patients who develop AF with those who do not.

Group 1: Postoperative AF Group

In patients undergoing coronary artery bypass graft surgery, ultrasound-guided measurements of visceral and subcutaneous adipose tissue will be performed preoperatively. The relationship between adipose tissue thickness and the development of postoperative atrial fibrillation will be evaluated by comparing patients who develop AF with those who do not.

Group 2: Non-AF Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients (≥18 years) scheduled for coronary artery bypass graft surgery.

You may qualify if:

  • Elective isolated coronary artery bypass graft surgery (on-pump)
  • Age ≥18 years, planned prospectively in 300 patients

You may not qualify if:

  • Patients requiring urgent or emergency surgery
  • Off-pump coronary artery bypass graft surgery
  • Surgeries other than isolated coronary artery bypass graft
  • Patients in whom abdominal ultrasound measurement cannot be performed (e.g., due to severe deformity, wounds, edema)
  • Active malignancy
  • eGFR \<30 mL/min
  • Advanced-stage chronic obstructive pulmonary disease (COPD)
  • Preoperative atrial fibrillation or atrial flutter
  • Patients who do not provide written informed consent for the study

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

OZGE PEKSEN KIZILISIK

CONTACT

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Anesthesiology and Reanimation Specialist, M.D.

Study Record Dates

First Submitted

March 8, 2026

First Posted

March 12, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 22, 2026

Study Completion (Estimated)

January 22, 2027

Last Updated

March 12, 2026

Record last verified: 2026-03