Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
|ClinicalTrials.gov Identifier: NCT01262222|
Recruitment Status : Active, not recruiting
First Posted : December 17, 2010
Last Update Posted : September 8, 2017
|Condition or disease||Intervention/treatment|
|High Risk for Postoperative Cardiovascular Events||Other: endothelial function testing|
|Study Type :||Observational|
|Estimated Enrollment :||200 participants|
|Official Title:||Endothelial Dysfunction in Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events|
|Study Start Date :||December 2010|
|Estimated Primary Completion Date :||December 2018|
|Estimated Study Completion Date :||December 2018|
pts undergoing major surg procedure referred to cardiology
Patients deemed to be at intermediate to high risk for postoperative cardiovascular events by clinical criteria will be the subject of this study. Cardiac risk will be determined according to the Revised Cardiac Risk Index (RCRI). RH-PAT testing and BNP evaluation will take place within 30 days before surgery and may occur on separate days. The blood may be drawn on the day of the RH-PAT testing or at a time of routine blood drawing within the 30 day period. After surgery the patient will be monitored and examined in the PACU for evidence of cardiac events.
Other: endothelial function testing
After obtaining informed consent, eligible patients will undergo endothelial function testing using the Endo-PAT 2000 (Itamar Medical) device. This PAT device applied to the finger tip will be used to measure change in blood flow in one arm at rest and after a 5 minute occlusion of the brachial artery with a blood pressure cuff. The other arm will serve as the patient's own control. After the cuff is deflated, blood flow normally increases in the arm for a period of time (flow mediated dilatation). In patients with abnormal endothelial function, this increase in blood flow is damped. The ratio of flow in the ischemic finger to the nonischemic finger (RH-PAT) will then be correlated with postoperative cardiac events.
- 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.
- To obtain preliminary information on whether abnormal FMD adds predictive information beyond risk algorithms [ Time Frame: 1 year ]proposed by the American Heart Association/American College of Cardiology.
- To determine whether abnormal flow mediated dilation (FMD) correlates to abnormal brain natriuretic enzyme BNP levels prior to surgery. [ Time Frame: 1 year ]
- To survey whether FMD prior to surgery is affected by treatment with chemotherapy and/or radiation prior to major cancer surgery [ Time Frame: 1 year ]
Biospecimen Retention: Samples Without DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01262222
|United States, New York|
|Memorial Sloan Kettering Cancer Center|
|New York, New York, United States, 10065|
|Principal Investigator:||Michael Baum, MD||Memorial Sloan Kettering Cancer Center|