Coronary Artery DiseaseNCT03142815
Aortic-Radial Pressure Gradients Post CPB
An observational study of Coronary Artery Disease, run by University of Iowa at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2017to 17 Mar 2020
- 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Iowa Hosptials and Clinics
Iowa City, Iowa, 52242
About this study
Official title: Correlation Between Arterial Stiffness and Aortic-to-radial Pressure Gradient After Cardiopulmonary Bypass
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.
Read the detailed description
The purpose of the study is determine if there is a relationship between pre-operative vascular characteristics including, carotid-femoral pulse wave velocity (cfPWV), Augmentation Index(AI) and central aortic pressure, and the development of a pressure gradient between the aorta and radial artery after cardiopulmonary bypass.
The procedures necessary to achieve the desired outcomes are as follows. The first measurement made by the research team will be pre-operative cardiac output (CO) measurement. The ICON device is a non-invasive device that measures CO, or the amount of blood that your heart pumps per minute. This device utilizes four stickers that are attached to skin, two on the left side of the neck and two located on the left side of the chest. These stickers function similarly to electrocardiogram (EKG) stickers that measure the electrical activity of your heart. After attachment of the stickers, the ICON device will be used to make a measurement of CO, which takes 1-2 minutes. After the measurement, the stickers will be removed and the ICON device will not be used again in the study.
Secondly, pre-operative cfPWV, AI, and central aortic pressure measurements will be made. The Sphygmocor device will be utilized to make the pre-operative cfPWV, AI and central aortic pressure measurements. First, the AI measurements will be made using a non-invasive blood pressure cuff placed on the right arm. The patient's blood pressure will be measured twice in a row with this special blood pressure cuff. The blood pressure cuff on the right arm will be removed and then a cuff will be placed around the right thigh. Measurements will be made with a paper ruler from the patient's neck to the cuff on their leg. To make the cfPWV measurements, the cuff on the thigh will inflate while a pressure probe will be placed on the skin of the patient's right neck. Four measurements of cfPWV will be made with this technique.
The intraoperative central aortic pressure measurement will be accomplished with the help of the cardiothoracic surgeon. The surgeon will place a catheter in the aorta as part of the coronary artery bypass grafting surgery. This catheter will be connected to the artificial heart-lung machine. Prior to turning on the heart-lung machine, the pressure in the aorta will be measured with this catheter. This is the standard of care for this type of surgery and will not delay the surgery. After the artificial heart-lung machine is turned off but before the catheter is removed from the aorta, the pressure will once again be measured.
In order to measure intraoperative CO values, we will utilize the pulmonary artery (PA) catheter that was placed at the beginning of the surgery.. The patient will have a catheter placed in the right side of the neck that will travel through the heart and into a branch of the artery that goes from the heart to the lungs. This catheter will have the ability to measure the amount of blood that is pumped from the heart per minute. At the same times that the pressure in the aorta is measured (as above), the amount of blood that is pumped from the heart per minute will be measured.
Lastly measurement of peripheral artery blood pressure will be accomplished with a right radial arterial catheter. Prior to the start of surgery, the patient will receive a special catheter in the radial artery of their right arm. This is the standard of care for blood pressure monitoring in this type of surgery. At the same times during the surgery that the pressure is being measured from the aortic catheter, the pressure will be measured from the catheter in the right radial artery.
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft (CABG), Arterial stiffness
- Medical subject headings
- Coronary Artery Disease
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 1 day (day of surgery)
Secondary outcomes (5)
Aortic pressure
Central aortic pressure will be measured before and after bypass.
Measured: 1 day (day of surgery)
Pulse pressure
Pulse pressure will be measured.
Measured: 1 day (day of surgery)
CO
Cardiac Output before and after coronary artery bypass
Measured: 1 day (day of surgery)
SVR
Systemic vascular resistance before and after coronary artery bypass
Measured: 1 day (day of surgery)
Risk factors
Pre-operative risk factors will be examined for any indication of development of aortic-to-radial pressure gradient after coronary artery bypass graft surgery.
Measured: 1 day (day of surgery)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start12 Jun 2017
- Primary completion17 Mar 2020
- Study completion17 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Iowa
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenichi Ueda, University of Iowa
- Investigators
- Kenichi Ueda, MD, PhD, Principal investigator, University of Iowa Department of Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142815
- Sponsor's protocol ID
- 201703834
- Status last verified
- May 2023
- First submitted
- 28 Apr 2017
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan currently to share IPD with other researchers.
Publications
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.
PubMed 12826841O'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.
PubMed 15699456Schmidt 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.
PubMed 16155037Zoremba 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.
PubMed 17944633
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Correlation Between Arterial Stiffness and Aortic-to-radial Pressure Gradient After Cardiopulmonary Bypass
- ClinicalTrials.gov ID
- NCT03142815
- Acronym / sponsor ID
- 201703834
- Conditions
- Coronary Artery Disease
- Keywords
- Coronary Artery Bypass Graft (CABG), Arterial stiffness
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of IowaUniversity, hospital or other
- Study start
- 12 Jun 2017 (actual)
- Primary completion
- 17 Mar 2020 (actual)
- Study completion
- 17 Mar 2020 (actual)
- First posted
- 5 May 2017 (actual)
- 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.
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.
Detailed description
The purpose of the study is determine if there is a relationship between pre-operative vascular characteristics including, carotid-femoral pulse wave velocity (cfPWV), Augmentation Index(AI) and central aortic pressure, and the development of a pressure gradient between the aorta and radial artery after cardiopulmonary bypass.
The procedures necessary to achieve the desired outcomes are as follows. The first measurement made by the research team will be pre-operative cardiac output (CO) measurement. The ICON device is a non-invasive device that measures CO, or the amount of blood that your heart pumps per minute. This device utilizes four stickers that are attached to skin, two on the left side of the neck and two located on the left side of the chest. These stickers function similarly to electrocardiogram (EKG) stickers that measure the electrical activity of your heart. After attachment of the stickers, the ICON device will be used to make a measurement of CO, which takes 1-2 minutes. After the measurement, the stickers will be removed and the ICON device will not be used again in the study.
Secondly, pre-operative cfPWV, AI, and central aortic pressure measurements will be made. The Sphygmocor device will be utilized to make the pre-operative cfPWV, AI and central aortic pressure measurements. First, the AI measurements will be made using a non-invasive blood pressure cuff placed on the right arm. The patient's blood pressure will be measured twice in a row with this special blood pressure cuff. The blood pressure cuff on the right arm will be removed and then a cuff will be placed around the right thigh. Measurements will be made with a paper ruler from the patient's neck to the cuff on their leg. To make the cfPWV measurements, the cuff on the thigh will inflate while a pressure probe will be placed on the skin of the patient's right neck. Four measurements of cfPWV will be made with this technique.
The intraoperative central aortic pressure measurement will be accomplished with the help of the cardiothoracic surgeon. The surgeon will place a catheter in the aorta as part of the coronary artery bypass grafting surgery. This catheter will be connected to the artificial heart-lung machine. Prior to turning on the heart-lung machine, the pressure in the aorta will be measured with this catheter. This is the standard of care for this type of surgery and will not delay the surgery. After the artificial heart-lung machine is turned off but before the catheter is removed from the aorta, the pressure will once again be measured.
In order to measure intraoperative CO values, we will utilize the pulmonary artery (PA) catheter that was placed at the beginning of the surgery.. The patient will have a catheter placed in the right side of the neck that will travel through the heart and into a branch of the artery that goes from the heart to the lungs. This catheter will have the ability to measure the amount of blood that is pumped from the heart per minute. At the same times that the pressure in the aorta is measured (as above), the amount of blood that is pumped from the heart per minute will be measured.
Lastly measurement of peripheral artery blood pressure will be accomplished with a right radial arterial catheter. Prior to the start of surgery, the patient will receive a special catheter in the radial artery of their right arm. This is the standard of care for blood pressure monitoring in this type of surgery. At the same times during the surgery that the pressure is being measured from the aortic catheter, the pressure will be measured from the catheter in the right radial artery.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Time frame: 1 day (day of surgery)
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)
Comparison of AI between patients who develop an aortic-to-radial pressure gradient and those who don't a pressure gradient
Time frame: 1 day (day of surgery)
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
5 secondary outcomes
Aortic pressure
Time frame: 1 day (day of surgery)
Pulse pressure
Time frame: 1 day (day of surgery)
CO
Time frame: 1 day (day of surgery)
SVR
Time frame: 1 day (day of surgery)
Risk factors
Time frame: 1 day (day of surgery)
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 11 May 2023.
- Background: PubMed 12826841Kanazawa 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.
- Background: PubMed 15699456O'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.
- Background: PubMed 16155037Schmidt 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.
- Background: PubMed 17944633Zoremba 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.
- Individual participant dataSharing planned: No. There is no plan currently to share IPD with other researchers.
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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.
Kenichi Ueda, MD, PhD principal investigator
University of Iowa Department of Anesthesia
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 Coronary Artery Disease, run by University of Iowa 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 1 inclusion and 1 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 11 May 2023. 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?
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 (time frame: 1 day (day of surgery)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03142815, which also lists 4 linked publications.
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 11 May 2023.