Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
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| First Received Date ICMJE | December 15, 2010 | ||||||||
| Last Updated Date | November 29, 2012 | ||||||||
| Start Date ICMJE | December 2010 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD). [ Time Frame: 1 year ] [ Designated as safety issue: No ] Identifies patients at high risk of cardiovascular complications after major thoracic or abdominal cancer surgery. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||||||
| Change History | Complete list of historical versions of study NCT01262222 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events | ||||||||
| Official Title ICMJE | Endothelial Dysfunction in Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events | ||||||||
| 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. |
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| Detailed Description | Not Provided | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Retention: Samples Without DNA Description: blood draw |
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| 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. |
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| Condition ICMJE | High Risk for Postoperative Cardiovascular Events | ||||||||
| Intervention ICMJE | 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. |
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| Study Group/Cohort (s) | 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.
Intervention: Other: endothelial function testing |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 200 | ||||||||
| Estimated Completion Date | December 2013 | ||||||||
| Estimated Primary Completion Date | December 2013 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 50 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01262222 | ||||||||
| Other Study ID Numbers ICMJE | 10-206 | ||||||||
| Has Data Monitoring Committee | Not Provided | ||||||||
| Responsible Party | Memorial Sloan-Kettering Cancer Center | ||||||||
| Study Sponsor ICMJE | Memorial Sloan-Kettering Cancer Center | ||||||||
| Collaborators ICMJE | Not Provided | ||||||||
| Investigators ICMJE |
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| Information Provided By | Memorial Sloan-Kettering Cancer Center | ||||||||
| Verification Date | November 2012 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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