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The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery

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ClinicalTrials.gov Identifier: NCT03656757
Recruitment Status : Completed
First Posted : September 3, 2018
Last Update Posted : March 21, 2019
Sponsor:
Collaborator:
St. Olavs Hospital
Information provided by (Responsible Party):
Norwegian University of Science and Technology

Brief 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. 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.

Condition or disease
Cardiovascular Diseases

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Study Type : Observational
Actual Enrollment : 41 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery
Actual Study Start Date : January 2, 2019
Actual Primary Completion Date : March 13, 2019
Actual Study Completion Date : March 13, 2019



Primary Outcome Measures :
  1. Arterioventricular coupling [ Time Frame: 1 day ]
    The ratio between arterial elastance and ventricular elastance

  2. Total Cardiac Power [ Time Frame: 1 day ]
    The amount of energy per second delivered from the left ventricle to the arterial circulation

  3. Oscillatory Cardiac Power [ Time Frame: 1 day ]
    The part of total cardiac power which is responsible for acceleration of the blood volume during systole.


Secondary Outcome Measures :
  1. Cardiac Output [ Time Frame: 1 day ]
    The hearts delivery of volume per minute

  2. Heart rate [ Time Frame: 1 day ]
    The amount of heart beats per minute

  3. Systemic vascular resistance [ Time Frame: 1 day ]
    The resistance to flow of the arterial tree



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
The population undergoing elective coronary artery bypass grafting typically have multiple cardiovascular risk factors such as hypertension, hyperlipidaemia, diabetes and smoking.
Criteria

Inclusion Criteria:

  • Elective Coronary Artery Bypass Graft patients
  • No contraindications to transoesophageal Echo
  • Ejection fraction 40% or over

Exclusion Criteria:

  • Lack of consent
  • Emergency operation
  • Prosthetic aortic valve

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03656757


Locations
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Norway
St Olavs Hospital
Trondheim, Norway
Sponsors and Collaborators
Norwegian University of Science and Technology
St. Olavs Hospital
Investigators
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Principal Investigator: Idar Kirkeby-Garstad, md phd Norwegian University of Science and Technology

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Responsible Party: Norwegian University of Science and Technology
ClinicalTrials.gov Identifier: NCT03656757     History of Changes
Other Study ID Numbers: 2017/767
First Posted: September 3, 2018    Key Record Dates
Last Update Posted: March 21, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Norwegian University of Science and Technology:
Cardiac Power
Oscillatory Power
Coronary Artery Bypass Graft
Arterioventricular Coupling

Additional relevant MeSH terms:
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Cardiovascular Diseases