Status:
COMPLETED
Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
Lead Sponsor:
Memorial Sloan Kettering Cancer Center
Conditions:
High Risk for Postoperative Cardiovascular Events
Eligibility:
All Genders
50+ years
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 complicat...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
December 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
July 11 2018
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT01262222
Start Date
December 1 2010
End Date
July 11 2018
Last Update
July 13 2018
Active Locations (1)
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1
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065