High Risk for Postoperative Cardiovascular EventsNCT01262222
Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
An observational study of High Risk for Postoperative Cardiovascular Events, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- High Risk for Postoperative Cardiovascular Events
- What is being tested?
- endothelial function testing
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2010to 11 Jul 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
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- 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."
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Being tested
- endothelial function testing
- Keywords
- Predictive Value For Postoperative Cardiac Events, Endothelial Dysfunction, 10-206
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endothelial function testingOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: endothelial function testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD).
Identifies patients at high risk of cardiovascular complications after major thoracic or abdominal cancer surgery.
Measured: 1 year
Secondary outcomes (3)
To obtain preliminary information on whether abnormal FMD adds predictive information beyond risk algorithms
proposed by the American Heart Association/American College of Cardiology.
Measured: 1 year
To determine whether abnormal flow mediated dilation (FMD) correlates to abnormal brain natriuretic enzyme BNP levels prior to surgery.
Measured: 1 year
To survey whether FMD prior to surgery is affected by treatment with chemotherapy and/or radiation prior to major cancer surgery
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2010 (estimated)
- Study startDec 2010
- Primary completion11 Jul 2018
- Study completion11 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for High Risk for Postoperative Cardiovascular EventsStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Baum, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01262222
- Sponsor's protocol ID
- 10-206
- Status last verified
- Jul 2018
- First submitted
- 15 Dec 2010
- Last updated
- 13 Jul 2018
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Dysfunction in Patients Undergoing Major Cancer Surgery: Incidence and Predictive Value for Postoperative Cardiac Events
- ClinicalTrials.gov ID
- NCT01262222
- Acronym / sponsor ID
- 10-206
- Keywords
- Predictive Value For Postoperative Cardiac Events, Endothelial Dysfunction, 10-206
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- 11 Jul 2018 (actual)
- Study completion
- 11 Jul 2018 (actual)
- First posted
- 17 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| pts undergoing major surg procedure referred to cardiology | – | Other: endothelial function testingPatients 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. |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (52 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endothelial function testingAfter 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. | Other | pts undergoing major surg procedure referred to cardiology |
Primary outcome
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.
3 secondary outcomes
To obtain preliminary information on whether abnormal FMD adds predictive information beyond risk algorithms
Time frame: 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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Memorial Sloan-Kettering Cancer CenterLink provided by the sponsor.
Related trials for High Risk for Postoperative Cardiovascular Events
RecruitingObservational study
Preoperative Exercise Testing and Perioperative Outcomes
Postoperative Complications (Cardiopulmonary)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Baum, MD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of High Risk for Postoperative Cardiovascular Events, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 52 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine whether endothelial dysfunction as measured by abnormal flow mediated dilation (FMD). (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2018.