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Clinical Trial Summary

The purpose of this study is to identify measures of obesity, functional capacity, and specific biomarkers that may be predictive of obesity and post-operative outcomes.

Clinical Trial Description

Background: Increasing levels of obesity worldwide have led to a rise in the prevalence of obesity-related complications including cardiovascular disease, diabetes, cancers etc. Health care providers believe that obesity has a negative effect on patients undergoing cardiac surgery, with overweight and obese patients being more likely to experience adverse post-operative outcomes. The body mass index (BMI) is the single most used measure for determining obesity classification in clinical practice, without accounting for a patient's level of cardiopulmonary fitness or muscle mass.

Study Design: Patients between the ages of 18 and 75 years undergoing elective cardiac surgery will be consented to participate in this prospective observational trial. Patients are invited to participate in measures of obesity, functional capacity and exercise capacity assessments, quality of life questionnaires, and blood and tissue sampling for biomarker analysis.

Endpoints: Measures other than BMI that could be predictive of short-term and long-term post-operative outcomes. Outcomes of interest include: prolonged length of ventilation, hospital length of stay and all-cause mortality.

Summary: The results of this trial will potentially identify an improved definition of fitness capacity for obese cardiac surgical patients and biomarkers alone or in combination that could identify the potential for adverse outcomes in patients undergoing cardiac surgery. This study will help clinicians better segregate and treat patients pre-operatively based on fitness levels and associated biomarkers. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT03248921
Study type Observational
Source Cardiovascular Research New Brunswick
Contact Ansar Hassan, MD, PhD
Phone 506-648-6102
Status Recruiting
Phase N/A
Start date November 2014
Completion date November 2025

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