Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events

Completed

• Conditions: High Risk for Postoperative Cardiovascular Events

• Registration Number: NCT01262222
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

The purpose of this study is to look at a new method for finding out if patients have a risk of heart complications from surgery. At the present, to find out if patients have a risk of heart complications from surgery, look at whether the patient has heart disease, diabetes, kidney problems, and stroke. The investigators hope that this study will confirm a new, safe test to help us predict the risk of surgery.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2010-12-15
• Study First Submitted QC: 2010-12-16
• Study First Posted: 2010-12-17
• Status Verified: 2018-07
• Primary Completion: 2018-07-11
• Study Completion: 2018-07-11
• Last Update Submitted: 2018-07-12
• Last Update Posted: 2018-07-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 67

Inclusion Criteria

• Age 50 or older
• Undergoing High Risk Cancer Surgery (Patient must be undergoing one of the following procedures NOTE: All open or robotic forms of the following procedures meet the eligibility criteria. GMT/ Hepatobiliary
• Pancreatic Resection
• Retroperitoneal Sarcomas
• Shoulder (Forequarter) Amputation
• Esophagectomy, Esophagogastrectomy
• Pheochromocytoma
• Liver Resection (with or without Bile Duct Resection) Orthopedics
• Spine Resections (with or without Spinal Fusion)
• Metastatic Disease Requiring Total Hip Replacement
• Total Shoulder Replacement / Forequarter Amputation
• Hemipelvectomy
• Sacrectomy Thoracic
• Extrapleural Pneumonectomy
• Pleurectomy and Decortication
• Pneumonectomy
• Esophagogastrectomy
• Mediastinal Tumor Resection
• Pancoast Tumor
• Completion Pneumonectomy
• Lobectomy (post-induction chemotherapy; or severe COPD)
• Segmentectomy Colorectal/ GYN
• Colon Resection with possible Sacrectomy
• Pelvic Exenteration
• Advanced ovarian cancer resection with or without liver resection Urology
• Radical Cystectomy
• Open Radical Prostatectomy
• Nephrectomy with Vena Caval Resection Head & Neck
• Thyroid Resection with Mediastinal involvement
• Major head and neck cancer resection with Free Flap reconstruction Other
• Unclassified Major Surgery at the Discretion of the PI
• Postoperative stay likely to be 2 or more days
• Patients willing to tolerate inflation of a blood pressure cuff for 5 minutes
• Patients willing to cut long nails in order to wear finger probe.
• Patients with one or more of the following RCRI risk factors:
• History of ischemic heart disease (any)
• History of myocardial infarction
• History of positive exercise test
• Current complaint of chest pain considered secondary to myocardial ischemia
• Use of nitrate therapy
• ECG with pathological Q waves
• History of congestive heart failure (any)
• History of congestive heart failure
• Pulmonary edema
• Paroxysmal nocturnal dyspnea
• Bilateral rales or S3 gallop
• Chest radiograph showing pulmonary vascular redistribution
• History of cerebrovascular disease (any)
• History of transient ischemic attack (TIA) or stroke
• Preoperative treatment with insulin
• Preoperative serum creatinine > 2.0 mg/dL
• Evidence of peripheral vascular disease other than cerebral vascular disease (Although peripheral vascular disease is not strictly a RCRI risk factor, Fleisher indicates: "It would not be inappropriate to assume that any atherosclerotic class of disease is equivalent to ischemic heart disease for risk purposes."

Exclusion Criteria

• Medical conditions precluding use of arm blood pressure measurements such as prior lymphadenectomy, vascular shunts for dialysis or upper extremity occlusive vascular disease
• Patients undergoing emergency surgery
• Any of the following active conditions
• Unstable coronary syndromes
• Uncompensated heart failure; worsening or new onset CHF
• Significant arrhythmias
• Atrial fibrillation, presently
• High grade AV block
• Symptomatic ventricular arrhythmias or new ventricular arrhythmias
• Supraventricular arrhythmias with poor rate control
• Symptomatic bradycardia
• Severe valvular disease
• Severe aortic stenosis (mean transvalvular gradient >40mmHg)
• Symptomatic mitral stenosis
• Any other condition that at the judgment of the investigator might require additional evaluation and treatment before surgery.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD).	1 year	Identifies patients at high risk of cardiovascular complications after major thoracic or abdominal cancer surgery.

Secondary Outcome Measures

Name	Time	Method
To obtain preliminary information on whether abnormal FMD adds predictive information beyond risk algorithms	1 year	proposed by the American Heart Association/American College of Cardiology.
To determine whether abnormal flow mediated dilation (FMD) correlates to abnormal brain natriuretic enzyme BNP levels prior to surgery.	1 year
To survey whether FMD prior to surgery is affected by treatment with chemotherapy and/or radiation prior to major cancer surgery	1 year

Trial Locations

Locations (1)

Memorial Sloan Kettering Cancer Center; 🇺🇸 New York, New York, United States