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

Memorial Sloan Kettering Cancer Center1 site in 1 country67 target enrollmentDecember 2010

ConditionsHigh Risk for Postoperative Cardiovascular Events

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: High Risk for Postoperative Cardiovascular Events
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 67
Locations: 1
Primary Endpoint: To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD).
Status: Completed
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

December 2010

End Date

July 11, 2018

Last Updated

7 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Memorial Sloan Kettering Cancer Center

Responsible Party

Sponsor

Eligibility Criteria

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

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

Outcomes

Primary Outcomes

To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD).

Time Frame: 1 year

Identifies patients at high risk of cardiovascular complications after major thoracic or abdominal cancer surgery.

Secondary Outcomes

To obtain preliminary information on whether abnormal FMD adds predictive information beyond risk algorithms(1 year)
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)