Coronary Artery Disease Clinical Trial
Official title:
Impact of New Anthropometric Indices on Outcomes After Cardiac Surgery
Verified date | July 2022 |
Source | TC Erciyes University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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 |
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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TC Erciyes University |
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 |
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