- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03656757
The Impact of Altered Arterioventricular Coupling on Central Cardiovascular Energy Delivery
March 19, 2019 updated by: Norwegian University of Science and Technology
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 Overview
Status
Completed
Conditions
Study Type
Observational
Enrollment (Actual)
41
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Trondheim, Norway
- St Olavs hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
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.
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Arterioventricular coupling
Time Frame: 1 day
|
The ratio between arterial elastance and ventricular elastance
|
1 day
|
|
Total Cardiac Power
Time Frame: 1 day
|
The amount of energy per second delivered from the left ventricle to the arterial circulation
|
1 day
|
|
Oscillatory Cardiac Power
Time Frame: 1 day
|
The part of total cardiac power which is responsible for acceleration of the blood volume during systole.
|
1 day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Cardiac Output
Time Frame: 1 day
|
The hearts delivery of volume per minute
|
1 day
|
|
Heart rate
Time Frame: 1 day
|
The amount of heart beats per minute
|
1 day
|
|
Systemic vascular resistance
Time Frame: 1 day
|
The resistance to flow of the arterial tree
|
1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Idar Kirkeby-Garstad, md phd, Norwegian University of Science and Technology
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 2, 2019
Primary Completion (Actual)
March 13, 2019
Study Completion (Actual)
March 13, 2019
Study Registration Dates
First Submitted
August 31, 2018
First Submitted That Met QC Criteria
August 31, 2018
First Posted (Actual)
September 4, 2018
Study Record Updates
Last Update Posted (Actual)
March 21, 2019
Last Update Submitted That Met QC Criteria
March 19, 2019
Last Verified
March 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2017/767
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Cardiovascular Diseases
-
Weill Medical College of Cornell UniversityAmerican Heart AssociationRecruitingCardiovascular | Cardiovascular Health | Cardiovascular (CV) Risk | Cardiovascular Disease (CVD) Risk FactorsUnited States
-
Hull University Teaching Hospitals NHS TrustNot yet recruitingCardiovascular Surgery | Cardiovascular Diseases (CVD)United Kingdom
-
Fu Jen Catholic UniversityRecruitingCardiovascular Disease | Cardiovascular SurgeryTaiwan
-
Medical College of WisconsinNational Center for Complementary and Integrative Health (NCCIH)CompletedCardiovascular Diseases | Cardiovascular Risk Factor | Cardiovascular HealthUnited States
-
Hospital Mutua de TerrassaCompleted
-
IRCCS Policlinico S. DonatoIRCCS San Raffaele; Fondazione Policlinico Universitario Agostino Gemelli IRCCS and other collaboratorsRecruitingCardiovascular Risk | Genetic Cardiovascular RiskItaly
-
Oregon Health and Science UniversityCompletedCardiovascular Disease | Cardiovascular Risk FactorsUnited States
-
Women's College HospitalUniversity Health Network, Toronto; Sunnybrook Health Sciences Centre; Brigham... and other collaboratorsUnknownCARDIOVASCULAR DISEASESCanada, United States
-
Groupe Hospitalier Paris Saint JosephTerminatedCARDIOVASCULAR DISEASESFrance
-
Children's Hospital Medical Center, CincinnatiRecruitingCardiovascular Diseases (CVD)United States