Clinical trial NCT01262222: Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
Official title: Endothelial Dysfunction in Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: High Risk for Postoperative Cardiovascular Events
Keywords: Predictive Value For Postoperative Cardiac Events
Endothelial Dysfunction
10-206
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2010-12-17
Enrollment: 67
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients scheduled for major intrathoracic or intraabdominal surgery who meet inclusion criteria and are seen either in preoperative cardiology consultation or by another pre-surgical service such as general medicine will be eligible for screening.

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.


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
* 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.

Primary outcomes:
measure: To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD).
timeFrame: 1 year
Secondary outcomes:
measure: To obtain preliminary information on whether abnormal FMD adds predictive information beyond risk algorithms
timeFrame: 1 year
measure: To determine whether abnormal flow mediated dilation (FMD) correlates to abnormal brain natriuretic enzyme BNP levels prior to surgery.
timeFrame: 1 year
measure: To survey whether FMD prior to surgery is affected by treatment with chemotherapy and/or radiation prior to major cancer surgery
timeFrame: 1 year
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michael Baum, MD
role: PRINCIPAL_INVESTIGATOR
References: