Cardiovascular DiseasesNCT03656757
The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery
An observational study of Cardiovascular Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study will assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases
- How many people
- 41 participants
- Where
- 1 siteNorway
- Study dates
- 2 Jan 2019to 13 Mar 2019
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The population undergoing elective coronary artery bypass grafting typically have multiple cardiovascular risk factors such as hypertension, hyperlipidaemia, diabetes and smoking.
Who may be able to join
- Elective Coronary Artery Bypass Graft patients
- No contraindications to transoesophageal Echo
- Ejection fraction 40% or over
Who cannot join
- Lack of consent
- Emergency operation
- Prosthetic aortic valve
Trial locations and contacts
1 site in 1 country.
About this study
This study will assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. Measurements will be taken just after induction of anaesthesia and repeated just after the end of the operation. The total energy delivered by the heart will be calculated by multiplying a pressure curve from the artery in the hand with the instantaneous ultrasound recorded cardiac output flow curve. The energy responsible for the acceleration of the blood volume, known as oscillatory power will also be calculated. The energy transfer will be calculated using a mathematical model based upon other ultrasound and blood pressure recorded variables. We would like to see if any alteration in energy delivered is in part due to impairment in energy transfer or alteration of fraction of oscillatory power rather than a change in total energy production. We would also like to study if there are changes in the oscillatory power after cardiac bypass surgery. The patients will be sampled sequentially into the study. We are not aware of any such studies undertaken in humans previously.
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiac Power, Oscillatory Power, Coronary Artery Bypass Graft, Arterioventricular Coupling
- Medical subject headings
- Cardiovascular Diseases
What is being measured
The primary outcome is the main question the study is designed to answer.
Arterioventricular coupling
The ratio between arterial elastance and ventricular elastance
Measured: 1 day
Total Cardiac Power
The amount of energy per second delivered from the left ventricle to the arterial circulation
Measured: 1 day
Oscillatory Cardiac Power
The part of total cardiac power which is responsible for acceleration of the blood volume during systole.
Measured: 1 day
Secondary outcomes (3)
Cardiac Output
The hearts delivery of volume per minute
Measured: 1 day
Heart rate
The amount of heart beats per minute
Measured: 1 day
Systemic vascular resistance
The resistance to flow of the arterial tree
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2018
- Study start2 Jan 2019
- Primary completion13 Mar 2019
- Study completion13 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Norwegian University of Science and TechnologyThe sponsor's other registered studies.
- 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
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian University of Science and Technology
- Sponsor type
- University, hospital or other
- Collaborators
- St. Olavs Hospital
- Responsible party
- Sponsor
- Investigators
- Idar Kirkeby-Garstad, md phd, Principal investigator, Norwegian University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03656757
- Sponsor's protocol ID
- 2017/767
- Status last verified
- Mar 2019
- First submitted
- 31 Aug 2018
- Last updated
- 21 Mar 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery
- ClinicalTrials.gov ID
- NCT03656757
- Acronym / sponsor ID
- 2017/767
- Conditions
- Cardiovascular Diseases
- Keywords
- Cardiac Power, Oscillatory Power, Coronary Artery Bypass Graft, Arterioventricular Coupling
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- 2 Jan 2019 (actual)
- Primary completion
- 13 Mar 2019 (actual)
- Study completion
- 13 Mar 2019 (actual)
- First posted
- 4 Sep 2018 (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 assess the amount of energy that the heart will deliver to the central circulation and the efficiency of that energy transfer, in patients undergoing a coronary artery bypass graft operation. Measurements will be taken just after induction of anaesthesia and repeated just after the end of the operation. The total energy delivered by the heart will be calculated by multiplying a pressure curve from the artery in the hand with the instantaneous ultrasound recorded cardiac output flow curve. The energy responsible for the acceleration of the blood volume, known as oscillatory power will also be calculated. The energy transfer will be calculated using a mathematical model based upon other ultrasound and blood pressure recorded variables. We would like to see if any alteration in energy delivered is in part due to impairment in energy transfer or alteration of fraction of oscillatory power rather than a change in total energy production. We would also like to study if there are changes in the oscillatory power after cardiac bypass surgery. The patients will be sampled sequentially into the study. We are not aware of any such studies undertaken in humans previously.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The population undergoing elective coronary artery bypass grafting typically have multiple cardiovascular risk factors such as hypertension, hyperlipidaemia, diabetes and smoking.
Key inclusion criteria (3 listed)
- Elective Coronary Artery Bypass Graft patients
- No contraindications to transoesophageal Echo
- Ejection fraction 40% or over
Key exclusion criteria (3 listed)
- Lack of consent
- Emergency operation
- Prosthetic aortic valve
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
Arterioventricular coupling
Time frame: 1 day
The ratio between arterial elastance and ventricular elastance
Total Cardiac Power
Time frame: 1 day
The amount of energy per second delivered from the left ventricle to the arterial circulation
Oscillatory Cardiac Power
Time frame: 1 day
The part of total cardiac power which is responsible for acceleration of the blood volume during systole.
3 secondary outcomes
Cardiac Output
Time frame: 1 day
Heart rate
Time frame: 1 day
Systemic vascular resistance
Time frame: 1 day
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 21 Mar 2019.
- Individual participant dataSharing planned: No
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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.
Idar Kirkeby-Garstad, md phd principal investigator
Norwegian University of Science and Technology
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 Cardiovascular Diseases, run by Norwegian University of Science and Technology at 1 site in Norway.
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 3 inclusion and 3 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 21 Mar 2019. 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 Norway. 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?
Arterioventricular coupling (time frame: 1 day). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 21 Mar 2019.