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

50 Years
Open (Enrolling)
High Risk for Postoperative Cardiovascular Events

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Trial Information

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

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

- 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.

Type of Study:


Study Design:

Observational Model: Case-Only, Time Perspective: Prospective

Outcome Measure:

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

Outcome Description:

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

Outcome Time Frame:

1 year

Safety Issue:


Principal Investigator

Michael Baum, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Memorial Sloan-Kettering Cancer Center


United States: Institutional Review Board

Study ID:




Start Date:

December 2010

Completion Date:

December 2014

Related Keywords:

  • High Risk for Postoperative Cardiovascular Events
  • Predictive Value For Postoperative Cardiac Events
  • Endothelial Dysfunction
  • 10-206



Memorial Sloan Kettering Cancer Center New York, New York  10021