An observational study in Obesity, Cardiac Disease and Cardiovascular Syndromes, Metabolic, sponsored by Cardiovascular Research New Brunswick. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Cardiovascular Research New Brunswick · Observational
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.
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.
6,570 studies on the registry are indexed under Obesity; 1,718 are open to participants now.
This study's planned enrollment of 610 is above the median of 132 across 1,338 observational studies indexed under Obesity.
Browse Obesity studies →Cardiovascular Research New Brunswick is the lead sponsor of 4 studies on the registry; none are open to participants now.
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All patients scheduled to undergo elective, first-time cardiac surgery will be considered for eligibility to participate in the study. As well, a patient whose BMI is less than 18.5 kg/m2 and classified as underweight by the World Health Organization will be excluded. Only those patients who are classified as being normal weight range or overweight and/or obese may be considered for eligibility to participate as defined by the study objectives regarding post-operative cardiac surgery outcomes in obese patients. Patients in the normal weight range classification will be included as a baseline control participant cohort. Finally, patients over the age of 75 will be excluded so as to eliminate the role that advanced age may play in affecting functional capacity.
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Exclusion Criteria:
Cardiac surgery patients will be segregated into the high-fit group based on 6 minute walk test distance and other measures of functional capacity
Procedure: cardiac surgery
Cardiac surgery patients will be segregated into the low-fit group based on 6 minute walk test distance and other measures of functional capacity
Procedure: cardiac surgery
cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery
Prolonged Hospitalization
A length of stay of more than 5 days
Time frame: post-operative day (POD) 30
Prolonged ventilation > 24 hours
mechanical ventilation for more than 24 hours of invasive (via endotracheal tube or tracheostomy) and/or noninvasive (facial/nasal interface) methods of delivery
Time frame: post-operative day (POD) 30
all cause mortality
Patient death, either in hospital or long-term
Time frame: post-operative day (POD) 30 and 1 year post-op
non fatal myocardial infarction
Transmural, Subendocardial infarction
Time frame: post-operative day (POD) 30 and 1 year post-op
Stroke
Transient, permanent
Time frame: post-operative day (POD) 30
Respiratory complications
Pleural effusion, pneumonia
Time frame: post-operative day (POD) 30
Prolonged ICU length of stay
length of stay of more than 48 hours
Time frame: post-operative day (POD) 30
Re-operation for any cause
re-operation due to complications, bleeding and/or other reasons
Time frame: post-operative day (POD) 30 and 1 year post-op
Atrial fibrillation
post-op occurrence requiring treatment
Time frame: post-operative day (POD) 30 and 1 year post-op
Post-operative length of stay and disposition on discharge
home, home with care, transfer to other facility, or expired
Time frame: post-operative day (POD) 30 and 1 year post-op
Wound infection
infection of sternum or other incisional access sites
Time frame: post-operative day (POD) 30
Plan to share: Undecided
This study is active, not recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Cardiovascular Research New Brunswick