Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

NCT05403294 | Unknown

• 1 other identifier: 2022/02
• Study Type: observational
• Target: 240
• Locations: 0 countries
• Sites: N/A

Brief Summary

Obesity is associated with a number of risk factors for cardiovascular disease. Body mass index (BMI) is the most commonly recommended and used anthropometric measure to classify general obesity in clinical and epidemiological studies. It is widely accepted that obesity increases the risk of heart disease and is thought to be a risk factor for adverse outcomes after cardiac surgery. However, recent studies show paradoxical results, wherein obese patients can experience fewer adverse events and lower mortality than patients with normal-low body mass index(BMI) . The discriminative capacity of BMI has been criticized because it cannot distinguish muscle mass from fat mass, or reflect fat distribution . Alternatively, abdominal obesity indices, such as waist circumference (WC) and waist-to-height ratio (WHtR), have been suggested to be better predictor of cardiometabolic abnormalities because they modulate the limitation of BMI. However, they were insufficient in studies.For this reason, scientists turned to find a new anthropometric formula that could better detect obesity-related mortality and morbidity and they developed 2 new methods. Body Shape İndex (ABSI) is calculated using waist circumference, BMI and height parameters. Body Roundness İndex (BRI) is calculated using waist circumference and height parameters. These new indices may reflect visceral adiposity and strongly predict cardiovascular risk, postsurgical outcomes and resource utilisation.

Conditions

Coronary Artery Disease; Cardiometabolic Risk Factors; Cardiac Anesthesia; Cardiac Surgery; Anthropometry

Outcome Measures

Primary Outcomes (5)

• mortality

  Number of death at 30 days after surgery

  within 30 days of the procedure

• postoperative stroke

  Number of patients with postoperative stroke

  within 30 days of the procedure

• cardiac arrest

  number of patients with cardiac arrest

  within 30 days of the procedure

• new atrial fibrillation/flutter

  Number of Partients with new atrial fibrillation/flutter

  within 30 days of the procedure

• permanent rhythm device insertion

  Number of Patients requiring insertion of a permanent device

  within 30 days of the procedure

Secondary Outcomes (6)

• prolonged ventilation

  within 30 days of the procedure

• sepsis /deep sternal infection

  within 30 days of the procedure

• pulmonary complications

  within 30 days of the procedure

• renal failure / renal dialysis

  within 30 days of the procedure

• total intensive care unit (ICU) hours

  within 30 days of the procedure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients over the age of 18 who have undergone open heart surgery

You may qualify if:

• open heart surgery
• voluntary patients

You may not qualify if:

• emergency surgery
• off-pump or robotic surgery
• surgery requiring deep hypothermic circulatory arrest
• reluctant patients

Sponsors & Collaborators

• TC Erciyes University: lead

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: May 2, 2022
• First Posted: June 3, 2022
• Study Start: July 27, 2022
• Primary Completion: October 1, 2022
• Study Completion: November 1, 2022
• Last Updated: July 28, 2022

Record last verified: 2022-07