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| Name | Class |
|---|---|
| Horizon Health Network | OTHER |
| Maritime Heart Centre | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| High-Fit obese | Cardiac surgery patients will be segregated into the high-fit group based on 6 minute walk test distance and other measures of functional capacity |
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| Low-Fit obese | Cardiac surgery patients will be segregated into the low-fit group based on 6 minute walk test distance and other measures of functional capacity |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| cardiac surgery | Procedure | cardiac surgery including non-emergency, elective coronary artery bypass grafting surgery with or without valve surgery, aortic or mitral valve surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Prolonged Hospitalization | A length of stay of more than 5 days | 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 | post-operative day (POD) 30 |
| Measure | Description | Time Frame |
|---|---|---|
| all cause mortality | Patient death, either in hospital or long-term | post-operative day (POD) 30 and 1 year post-op |
| non fatal myocardial infarction | Transmural, Subendocardial infarction |
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Inclusion Criteria:
· Provide informed consent
Exclusion Criteria:
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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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| Name | Affiliation | Role |
|---|---|---|
| Ansar Hassan, MD, PhD | New Brunswick Heart Centre, Department of Cardiac Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saint John Regional Hospital | Saint John | New Brunswick | E2L 4L2 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30833313 | Background | Aguiar C, MacLeod J, Yip A, Melville S, Legare JF, Pulinilkunnil T, Kienesberger P, Brunt K, Hassan A. Impact of Obesity on Postoperative Outcomes following cardiac Surgery (The OPOS study): rationale and design of an investigator-initiated prospective study. BMJ Open. 2019 Mar 3;9(3):e023418. doi: 10.1136/bmjopen-2018-023418. | |
| 32671100 |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D006331 | Heart Diseases |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006348 | Cardiac Surgical Procedures |
| ID | Term |
|---|---|
| D013504 | Cardiovascular Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D019616 | Thoracic Surgical Procedures |
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The following biological samples have been approved for collection: 4 types of adipose tissue (subcutaneous adipose tissue; epicardial adipose tissue; pericardial adipose tissue; peri-aortic adipose tissue); atrial appendage tissue sample; and 8-10mL blood sample (plasma and serum sample).
| post-operative day (POD) 30 and 1 year post-op |
| Stroke | Transient, permanent | post-operative day (POD) 30 |
| Respiratory complications | Pleural effusion, pneumonia | post-operative day (POD) 30 |
| Prolonged ICU length of stay | length of stay of more than 48 hours | post-operative day (POD) 30 |
| Re-operation for any cause | re-operation due to complications, bleeding and/or other reasons | post-operative day (POD) 30 and 1 year post-op |
| Atrial fibrillation | post-op occurrence requiring treatment | 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 | post-operative day (POD) 30 and 1 year post-op |
| Wound infection | infection of sternum or other incisional access sites | post-operative day (POD) 30 |
| Sarkar S, Legere S, Haidl I, Marshall J, MacLeod JB, Aguiar C, Lutchmedial S, Hassan A, Brunt KR, Kienesberger P, Pulinilkunnil T, Legare JF. Serum GDF15, a Promising Biomarker in Obese Patients Undergoing Heart Surgery. Front Cardiovasc Med. 2020 Jun 24;7:103. doi: 10.3389/fcvm.2020.00103. eCollection 2020. |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D002318 | Cardiovascular Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |