Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events

July 12, 2018 updated by: Memorial Sloan Kettering Cancer Center

Endothelial Dysfunction in Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
67

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New York
      • New York, New York, United States, 10065
        • Memorial Sloan Kettering Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
1 year

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
1 year
To determine whether abnormal flow mediated dilation (FMD) correlates to abnormal brain natriuretic enzyme BNP levels prior to surgery.
Time Frame: 1 year
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
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Memorial Sloan Kettering Cancer Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Michael Baum, MD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2010

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 11, 2018

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 11, 2018

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 15, 2010

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 16, 2010

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 17, 2010

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 13, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 12, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2018

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 10-206

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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