Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

Coronary Artery Disease Clinical Trial

Official title:

Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05403294
• Other study ID #: 2022/02
• Status: Not yet recruiting
• Start date: July 27, 2022
• Est. completion date: November 1, 2022

Study information

• Verified date: July 2022
• Source: TC Erciyes University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 240
• Est. completion date: November 1, 2022
• Est. primary completion date: October 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• open heart surgery
• voluntary patients

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Anthropometry
• Cardiac Surgery
• Cardiometabolic Risk Factors
• Coronary Artery Disease

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
TC Erciyes University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mortality	Number of death at 30 days after surgery	within 30 days of the procedure
Primary	postoperative stroke	Number of patients with postoperative stroke	within 30 days of the procedure
Primary	cardiac arrest	number of patients with cardiac arrest	within 30 days of the procedure
Primary	new atrial fibrillation/flutter	Number of Partients with new atrial fibrillation/flutter	within 30 days of the procedure
Primary	permanent rhythm device insertion	Number of Patients requiring insertion of a permanent device	within 30 days of the procedure
Secondary	prolonged ventilation	number of patients experiencing prolonged postoperative pulmonary ventilation (>24 hours)	within 30 days of the procedure
Secondary	sepsis /deep sternal infection	number of patients with sepsis, deep sternal wound infection or mediastinitis	within 30 days of the procedure
Secondary	pulmonary complications	number of patients with pneumonia or pleural effusion	within 30 days of the procedure
Secondary	renal failure / renal dialysis	number of patient with acute renal failure or worsening renal function result	within 30 days of the procedure
Secondary	total intensive care unit (ICU) hours	total intensive care unit (ICU) hours	within 30 days of the procedure
Secondary	intensive care unit (ICU) readmissions	number of patients with intensive care unit readmission	within 30 days of the procedure