Pulse Wave Velocity as a Predictor for Postoperative Cardiovascular Events

NCT03223441 | Completed

• 1 other identifier: 201502761
• Study Type: observational
• Target: 543
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-Op Complication; Arterial Stiffness

Keywords

Pulse wave velocity; anesthesia

Outcome Measures

Primary Outcomes (1)

• Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't

  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)

  One month after surgery

Secondary Outcomes (3)

• Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't

  7 days

• Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't

  6 months

• Comparison of vascular stiffness between patients who develop a postoperative adverse cardiac event and those who don't

  1 year

Eligibility Criteria

• Age: 40 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients who are undergoing surgery and aged 40 and above

You may qualify if:

• Elective major surgery (scheduled \> 4hours) patients, age 40 and up, will be recruited.
• GENERAL SURGERY- cholecystectomy, esophagectomy, gastric or bowel resection, gastric sleeve resections, liver resection, pancreatectomy, pheochromocytoma excision;
• HEAD \& NECK SURGERY- laryngectomy radical neck dissection;
• NEUROSURGERY- craniotomy for brain tumor resection;
• ORTHOPEDIC SURGERY- total hip, total knee, total shoulder repair;
• SPINE SURGERY- multilevel lumbar or thoracic laminectomy, spinal stenosis decompression and stabilization;
• THORACIC SURGERY- open lobectomy, pneumonectomy
• UROLOGY- cystoprostatectomy, nephrectomy, and prostatectomy
• VASCULAR SURGERY- carotic endarterectomy, endovascular or open AAA repair, aortofemoral bypass, axillo-femoral bypass;
• GYNECOLOGY SURGERY- hysterectomy
• At least ONE readily palpable CAROTID, RADIAL and FEMORAL artery pulse;
• A signed informed consent form

You may not qualify if:

• Cardiac surgery
• Emergency surgical procedure;
• Poorly or nonpalpable carotic, radial and/or femoral pulses;
• A history of dizziness or fainting from carotic artery palpation
• Atrial fibrillation or flutter

Sponsors & Collaborators

• Kenichi Ueda: lead

Study Sites (1)

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (7)

• Barodka VM, Joshi BL, Berkowitz DE, Hogue CW Jr, Nyhan D. Review article: implications of vascular aging. Anesth Analg. 2011 May;112(5):1048-60. doi: 10.1213/ANE.0b013e3182147e3c. Epub 2011 Apr 7.

  PMID: 21474663 BACKGROUND

• HARKNESS ML, HARKNESS RD, MCDONALD DA. The collagen and elastin content of the arterial wall in the dog. Proc R Soc Lond B Biol Sci. 1957 Jun 25;146(925):541-51. doi: 10.1098/rspb.1957.0029. No abstract available.

  PMID: 13441679 BACKGROUND

• O'Rourke MF, Nichols WW. Aortic diameter, aortic stiffness, and wave reflection increase with age and isolated systolic hypertension. Hypertension. 2005 Apr;45(4):652-8. doi: 10.1161/01.HYP.0000153793.84859.b8. Epub 2005 Feb 7. No abstract available.

  PMID: 15699456 BACKGROUND

• Williams B, Lacy PS, Thom SM, Cruickshank K, Stanton A, Collier D, Hughes AD, Thurston H, O'Rourke M; CAFE Investigators; Anglo-Scandinavian Cardiac Outcomes Trial Investigators; CAFE Steering Committee and Writing Committee. Differential impact of blood pressure-lowering drugs on central aortic pressure and clinical outcomes: principal results of the Conduit Artery Function Evaluation (CAFE) study. Circulation. 2006 Mar 7;113(9):1213-25. doi: 10.1161/CIRCULATIONAHA.105.595496. Epub 2006 Feb 13.

  PMID: 16476843 BACKGROUND

• London GM, Asmar RG, O'Rourke MF, Safar ME; REASON Project Investigators. Mechanism(s) of selective systolic blood pressure reduction after a low-dose combination of perindopril/indapamide in hypertensive subjects: comparison with atenolol. J Am Coll Cardiol. 2004 Jan 7;43(1):92-9. doi: 10.1016/j.jacc.2003.07.039.

  PMID: 14715189 BACKGROUND

• Lee TH, Marcantonio ER, Mangione CM, Thomas EJ, Polanczyk CA, Cook EF, Sugarbaker DJ, Donaldson MC, Poss R, Ho KK, Ludwig LE, Pedan A, Goldman L. Derivation and prospective validation of a simple index for prediction of cardiac risk of major noncardiac surgery. Circulation. 1999 Sep 7;100(10):1043-9. doi: 10.1161/01.cir.100.10.1043.

  PMID: 10477528 BACKGROUND

• Gupta PK, Gupta H, Sundaram A, Kaushik M, Fang X, Miller WJ, Esterbrooks DJ, Hunter CB, Pipinos II, Johanning JM, Lynch TG, Forse RA, Mohiuddin SM, Mooss AN. Development and validation of a risk calculator for prediction of cardiac risk after surgery. Circulation. 2011 Jul 26;124(4):381-7. doi: 10.1161/CIRCULATIONAHA.110.015701. Epub 2011 Jul 5.

  PMID: 21730309 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Postoperative Complications

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Associate Professor

Study Record Dates

• First Submitted: July 1, 2017
• First Posted: July 21, 2017
• Study Start: June 1, 2015
• Primary Completion: February 1, 2018
• Study Completion: February 1, 2018
• Last Updated: April 17, 2018

Record last verified: 2018-04

Locations

US (1)