In-human Validation of a Technique for Measuring Central Aortic Hemodynamics With Peripheral Arterial Waveforms

NCT01567748 | Completed DMC

• 1 other identifier: 00021889
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

Central aortic blood pressure (BP) and flow are generally more informative about the health condition of the heart and the arterial system compared with BP measured in peripheral locations (e.g. arm or leg). However, their clinical impact has been limited due to the cost, risk and discomfort associated with their measurements. Peripheral BP is attractive because it can be measured relatively easily than central aortic BP. However, peripheral BP is not as useful as central aortic BP since the shape of its waveform is different from that of central aortic BP. The applicant recently developed two innovative methods, the "Individualized Transfer Functions (ITF)," which is able to estimate the central aortic BP waveform of a patient using the measurements of peripheral BP waveform(s). The methods were successfully validated using animal and simulated human subjects. The objective of the proposed research project is to examine the validity of these innovative methods in human subjects. Cardiovascular disease accounts for 1/3 of all deaths and more than $22 billion healthcare-related cost in Canada every year. The proposed research project will make significant contribution in improving clinical care by the potential of ITF in detection and diagnostics of cardiovascular disease. In fact, the proposed research project is a key initial step towards our long-term research objective of non-invasive cardiovascular disease diagnostics. The success of the proposed research project will demonstrate that ITF can serve as a low-cost, non-invasive and convenient alternative for central aortic BP measurement, which can further be used for the development of detection and diagnostics methods for a number of cardiovascular diseases (e.g. aortic valve impairment and peripheral arterial disease) by virtue of the relevant health and disease conditions of central and peripheral arterial vessels that ITF can deliver.

Conditions

Coronary Artery Disease

Keywords

CABG; Coronary Artery Bypass; Central Aortic Pressure; Peripheral Arterial Waveform

Outcome Measures

Primary Outcomes (1)

• Validate ITF Methodology

  We will collect the relevant circulatory (BP) data and apply these data to validate the Individualized Transfer Function (ITF) methodology

  Intra Operatively

Study Arms (1)

Hemodynamics Measured

The following additional research related procedures will be performed in patients recruited into the study: 1) a small cuff will be placed on one the finger of each subject to measure the pulse in the finger (Finapres); 2) a cannula will be placed in the femoral artery by the surgeon to measure femoral artery pressure; 3) for a period of two minutes immediately before and after the cardiopulmonary bypass a small cannula (the size of a pencil tip) will be inserted by the surgeon under direct vision into the aorta and 4) the information from each of these cannula will be recorded on a computer for later study.

Procedure: BP Measurements at aorta, radial and femoral locations

Interventions

BP Measurements at aorta, radial and femoral locations PROCEDURE

The following additional research related procedures will be performed in patients recruited into the study: 1) a small cuff will be placed on one the finger of each subject to measure the pulse in the finger (Finapres); 2) a cannula will be placed in the femoral artery by the surgeon to measure femoral artery pressure; 3) for a period of two minutes immediately before and after the cardiopulmonary bypass a small cannula (the size of a pencil tip) will be inserted by the surgeon under direct vision into the aorta and 4) the information from each of these cannula will be recorded on a computer for later study.

Hemodynamics Measured

Eligibility Criteria

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

Study Population

This study is looking at those individuals undergoing Coronary Artery Bypass surgery requiring CPB, between the age of 18-80, with a BMI \< 35.

You may qualify if:

• Written informed consent
• Age 18 through 80 years, inclusive
• Scheduled for coronary artery bypass surgery with CPB

You may not qualify if:

• Scheduled for heart surgery other than coronary artery bypass surgery
• Females of childbearing potential
• Emergency surgery
• BMI \> 35

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta Hospital/Mazankowski Alberta Heart Institute

Edmonton, Alberta, T6G 2G3, Canada

Location

Related Publications (5)

• Safar ME, Jankowski P. Central blood pressure and hypertension: role in cardiovascular risk assessment. Clin Sci (Lond). 2009 Feb;116(4):273-82. doi: 10.1042/CS20080072.

  PMID: 19138169 BACKGROUND

• Papaioannou TG, Protogerou AD, Stamatelopoulos KS, Vavuranakis M, Stefanadis C. Non-invasive methods and techniques for central blood pressure estimation: procedures, validation, reproducibility and limitations. Curr Pharm Des. 2009;15(3):245-53. doi: 10.2174/138161209787354203.

  PMID: 19149616 BACKGROUND

• J.O. Hahn et al., 2009, ASME Journal of Dynamic Systems, Measurement and Control 131: 051009

  BACKGROUND

• J.O. Hahn et al., 2009, Control Engineering Practice 17: 1318-1328

  BACKGROUND

• Hahn JO, Reisner AT, Asada HH. Estimation of pulse transit time using two diametric blood pressure waveform measurements. Med Eng Phys. 2010 Sep;32(7):753-9. doi: 10.1016/j.medengphy.2010.04.017. Epub 2010 May 26.

  PMID: 20537933 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

• Barry A Finegan, MB

  University of Alberta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Clinical Professor, Department of Anesthesiology

Study Record Dates

• First Submitted: February 14, 2012
• First Posted: March 30, 2012
• Study Start: January 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: April 1, 2014
• Last Updated: December 5, 2014

Record last verified: 2014-12

Locations

CA (1)