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Pulse Wave Velocity as a Predictor for Postoperative Cardiovascular Events

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ClinicalTrials.gov Identifier: NCT03223441
Recruitment Status : Completed
First Posted : July 21, 2017
Last Update Posted : April 17, 2018
Sponsor:
Information provided by (Responsible Party):
Kenichi Ueda, University of Iowa

Brief Summary:

Vascular stiffness increases as a person ages, due to the repetitive stress that is put on the vascular system which causes changes in the elasticity of the vessel walls. The increased stiffness of the arteries puts added stress on the circulatory system. This rise in stiffness has been shown to be associated with an increased risk of cardiovascular events, in both presumably healthy patients, as well as elderly patients The current method for assessing perioperative cardiac risk is the Goldman's Revised Cardiac Risk Index (RCRI). This method, however, does not include a direct measurement of arterial stiffness. Applanation tonometry is a non-invasive technique that has been shown to reliably provide indices of arterial stiffness While the use of applanation tonometry has been widely studied in general medicine, it is has not been studied for pre-operative risk assessment in surgical patients.

The purpose of this investigation is to examine whether aortic stiffness is an independent risk factor for developing cardiovascular related adverse events in patients who are having major surgery under general anesthesia.

Applanation tonometry will be performed on the right carotid and femoral arteries to assess carotid-femoral pulse wave velocity, a surrogate for aortic stiffness. (SphygmoCor system, AtCor Medical, Sydney, Australia). The measurement will be obtained before induction of general anesthesia in the presurgical area. Patients' medical history, intraoperative hemodynamics, and any postoperative complications will be recorded to determine significant correlations and relationships. This information will potentially help identify future patients that might be at greater risk of developing an adverse cardiovascular event following their surgical procedure.


Condition or disease
Post-Op Complication Arterial Stiffness

  Show Detailed Description

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Study Type : Observational
Actual Enrollment : 543 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Pulse Wave Velocity as a Predictor for Postoperative Cardiovascular Events
Study Start Date : June 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : February 2018



Primary Outcome Measures :
  1. Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't [ Time Frame: One month after surgery ]
    The study is aimed to compare arterial stiffness between patients who develop postoperative adverse cardiac complications and those who don't in patients who are undergoing major elective surgery. This includes coronary artery disease, congestive heart failure, cereberal artery disease, thrombolic event, carotid artery disease, kidney injury, valvular disease, significant EKG changes, respiratory failure and death. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device (Atcor, Sydney, Australia)


Secondary Outcome Measures :
  1. Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't [ Time Frame: 7 days ]
    The study is aimed to compare arterial stiffness between patients who develop postoperative adverse cardiac complications and those who don't in patients who are undergoing major elective surgery. This includes coronary artery disease, congestive heart failure, cerebral artery disease, thrombolic event, carotid artery disease, kidney injury, valvular disease, significant EKG changes, respiratory failure and death. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device (Atcor, Sydney, Australia)

  2. Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't [ Time Frame: 6 months ]
    The study is aimed to compare arterial stiffness between patients who develop postoperative adverse cardiac complications and those who don't in patients who are undergoing major elective surgery. This includes new onset from 6 month coronary artery disease, congestive heart failure, cerebral artery disease, thrombolic event, carotid artery disease, kidney injury, valvular disease, significant EKG changes, respiratory failure and death. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device (Atcor, Sydney, Australia)

  3. Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't [ Time Frame: 1 year ]
    The study is aimed to compare arterial stiffness between patients who develop postoperative adverse cardiac complications and those who don't in patients who are undergoing major elective surgery. This includes coronary artery disease, congestive heart failure, cerbral artery disease, thrombolic event, carotid artery disease, kidney injury, valvular disease, significant EKG changes, respiratory failure and death. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device (Atcor, Sydney, Australia)



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Ages Eligible for Study:   40 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients who are undergoing surgery and aged 40 and above
Criteria

Inclusion Criteria:

Elective major surgery (scheduled > 4hours) patients, age 40 and up, will be recruited.

  1. Surgical procedures and conditions that would meet INCLUSION criteria:

    1. GENERAL SURGERY- cholecystectomy, esophagectomy, gastric or bowel resection, gastric sleeve resections, liver resection, pancreatectomy, pheochromocytoma excision;
    2. HEAD & NECK SURGERY- laryngectomy radical neck dissection;
    3. NEUROSURGERY- craniotomy for brain tumor resection;
    4. ORTHOPEDIC SURGERY- total hip, total knee, total shoulder repair;
    5. SPINE SURGERY- multilevel lumbar or thoracic laminectomy, spinal stenosis decompression and stabilization;
    6. THORACIC SURGERY- open lobectomy, pneumonectomy
    7. UROLOGY- cystoprostatectomy, nephrectomy, and prostatectomy
    8. VASCULAR SURGERY- carotic endarterectomy, endovascular or open AAA repair, aortofemoral bypass, axillo-femoral bypass;
    9. GYNECOLOGY SURGERY- hysterectomy
  2. At least ONE readily palpable CAROTID, RADIAL and FEMORAL artery pulse;
  3. A signed informed consent form

Exclusion Criteria:

  1. Cardiac surgery
  2. Emergency surgical procedure;
  3. Poorly or nonpalpable carotic, radial and/or femoral pulses;
  4. A history of dizziness or fainting from carotic artery palpation
  5. Atrial fibrillation or flutter

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03223441


Locations
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United States, Iowa
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States, 52242
Sponsors and Collaborators
Kenichi Ueda

Additional Information:
Publications:

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Responsible Party: Kenichi Ueda, Clinical Associate Professor, University of Iowa
ClinicalTrials.gov Identifier: NCT03223441     History of Changes
Other Study ID Numbers: 201502761
First Posted: July 21, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018

Keywords provided by Kenichi Ueda, University of Iowa:
Pulse wave velocity
anesthesia

Additional relevant MeSH terms:
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Postoperative Complications
Pathologic Processes