Clinical Trial Details
Braintumor Website

[Information provided by: ClinicalTrials.gov, which provides patients, family members, and members of the public easy and free access to information on clinical studies for a wide range of diseases and conditions.]

NCT01262222 : Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
PhaseN/A
AgesMin: 50 Years Max: N/A
Eligibility
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.
LinksPermanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT01262222      |      Link to official Clinicaltrials.gov listing
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