Aortic-Radial Pressure Gradients Post CPB

NCT03142815 | Completed

• 1 other identifier: 201703834
• Study Type: observational
• Target: 90
• Locations: 1 country
• Sites: 1

Brief Summary

This study will examine whether pre-operative, non-invasive arterial stiffness measurements can be used to predict which patients will develop an aortic-to-radial pressure gradient after coronary artery bypass graft (CABG) surgery. A previous small study by Kanazawa, et al. demonstrated in patients who developed an aortic-to-radial pressure gradient after CABG surgery, the pulse wave velocity (PWV) was higher in the aorta and decreased when moving toward the radial artery. In the patients who did not develop a pressure gradient, the PWV started lower in the aorta and increased when moving towards the periphery. The purpose of this investigation is to examine whether pre-operative PWV measurements can be used to identify patients who will develop an aortic to radial pressure gradient after CABG surgery. 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. Also in the presurgical area, a non-invasive cardiac output (CO) measurement will be obtained by using the ICON Device (Osypka Medical, La Jolla, California). This CO value will be used to compare to the CO values obtained invasively in the operating room.

Conditions

Coronary Artery Disease

Keywords

Coronary Artery Bypass Graft (CABG), Arterial stiffness

Outcome Measures

Primary Outcomes (2)

• Comparison of pre-operative carotid-femoral pulse wave velocity (cfPWV)between patients who develop an aortic-to-radial pressure gradient after coronary artery bypass surgery and those who don't develop a pressure gradient

  The study is aimed to compare cfPWV between patients who develop an aortic-to-radial pressure gradient after coronary artery bypass and those who don't who are undergoing coronary artery bypass graft surgery. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device (Atcor, Sydney, Australia)

  1 day (day of surgery)

• Comparison of AI between patients who develop an aortic-to-radial pressure gradient and those who don't a pressure gradient

  The study is aimed to compare AI between patients who develop an aortic-to-radial pressure gradient after coronary artery bypass and those who don't who are undergoing coronary artery bypass graft surgery. Arterial stiffness will be measured by pulse wave velocity (m/s) with a SphygmoCor® device

  1 day (day of surgery)

Secondary Outcomes (5)

• Aortic pressure

  1 day (day of surgery)

• Pulse pressure

  1 day (day of surgery)

• CO

  1 day (day of surgery)

• SVR

  1 day (day of surgery)

• Risk factors

  1 day (day of surgery)

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The study population will include adult patients aged 40-80 years old who are scheduled to undergo elective on-pump coronary artery bypass graft (CABG) surgery.

You may qualify if:

• Adult patients, age 40-80, who are scheduled to undergo elective coronary artery bypass graft (CABG) surgery at the University of Iowa Hospitals and Clinics.

You may not qualify if:

• off-pump CABG surgery, emergency cases, patients who already have a balloon pump or major valvular heart disease, and if preoperative PWV is not obtainable for any reason.

Sponsors & Collaborators

• University of Iowa: lead

Study Sites (1)

University of Iowa Hosptials and Clinics

Iowa City, Iowa, 52242, United States

Location

Related Publications (4)

• Kanazawa M, Fukuyama H, Kinefuchi Y, Takiguchi M, Suzuki T. Relationship between aortic-to-radial arterial pressure gradient after cardiopulmonary bypass and changes in arterial elasticity. Anesthesiology. 2003 Jul;99(1):48-53. doi: 10.1097/00000542-200307000-00011.

  PMID: 12826841 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

• Schmidt C, Theilmeier G, Van Aken H, Korsmeier P, Wirtz SP, Berendes E, Hoffmeier A, Meissner A. Comparison of electrical velocimetry and transoesophageal Doppler echocardiography for measuring stroke volume and cardiac output. Br J Anaesth. 2005 Nov;95(5):603-10. doi: 10.1093/bja/aei224. Epub 2005 Sep 9.

  PMID: 16155037 BACKGROUND

• Zoremba N, Bickenbach J, Krauss B, Rossaint R, Kuhlen R, Schalte G. Comparison of electrical velocimetry and thermodilution techniques for the measurement of cardiac output. Acta Anaesthesiol Scand. 2007 Nov;51(10):1314-9. doi: 10.1111/j.1399-6576.2007.01445.x.

  PMID: 17944633 BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Kenichi Ueda, MD, PhD

  University of Iowa Department of Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: April 28, 2017
• First Posted: May 5, 2017
• Study Start: June 12, 2017
• Primary Completion: March 17, 2020
• Study Completion: March 17, 2020
• Last Updated: May 11, 2023

Record last verified: 2023-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)