NCT03656757

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2019

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 31, 2018

Completed
4 days until next milestone

First Posted

Study publicly available on registry

September 4, 2018

Completed
4 months until next milestone

Study Start

First participant enrolled

January 2, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 13, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 13, 2019

Completed
Last Updated

March 21, 2019

Status Verified

March 1, 2019

Enrollment Period

2 months

First QC Date

August 31, 2018

Last Update Submit

March 19, 2019

Conditions

Keywords

Cardiac PowerOscillatory PowerCoronary Artery Bypass GraftArterioventricular Coupling

Outcome Measures

Primary Outcomes (3)

  • Arterioventricular coupling

    The ratio between arterial elastance and ventricular elastance

    1 day

  • Total Cardiac Power

    The amount of energy per second delivered from the left ventricle to the arterial circulation

    1 day

  • Oscillatory Cardiac Power

    The part of total cardiac power which is responsible for acceleration of the blood volume during systole.

    1 day

Secondary Outcomes (3)

  • Cardiac Output

    1 day

  • Heart rate

    1 day

  • Systemic vascular resistance

    1 day

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • Lack of consent
  • Emergency operation
  • Prosthetic aortic valve

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St Olavs Hospital

Trondheim, Norway

Location

MeSH Terms

Conditions

Cardiovascular Diseases

Study Officials

  • Idar Kirkeby-Garstad, md phd

    Norwegian University of Science and Technology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2018

First Posted

September 4, 2018

Study Start

January 2, 2019

Primary Completion

March 13, 2019

Study Completion

March 13, 2019

Last Updated

March 21, 2019

Record last verified: 2019-03

Data Sharing

IPD Sharing
Will not share

Locations