Coronary DiseaseNCT02765607
Circulatory Oscillations in Post Cardiac Surgery Patients
An observational study of Coronary Disease, run by St. Olavs Hospital at 1 site in Norway.
Trial summary
In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Disease
- What is being tested?
- Heart surgery
- Type of treatment
- Surgery or procedure
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- Mar 2016to Dec 2017
- 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: Patients scheduled for routine coronary artery bypass graft (CABG) surgery.
Who may be able to join
- patients scheduled for routine coronary artery bypass graft (CABG) surgery, single procedure only
Who cannot join
- no sinus or pacemaker rhythm
- ejection fraction below 0.5
- serious valvular disease
- right ventricular failure
- pulmonary hypertension
- serious postoperative bleeding
Trial locations and contacts
1 site in 1 country.
About this study
In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.
- Conditions
- Coronary Disease
- Being tested
- Heart surgery
- Keywords
- Blood circulation, Cardiac surgical procedures, Homeostasis
- Medical subject headings
- Coronary Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Heart surgeryProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency and amplitude of oscillations of electrocardiogram (ECG)
analyzed by continuous wavelet transform
Measured: First day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2016 (estimated)
- Study startMar 2016
- Primary completionDec 2017
- Study completionDec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronary DiseaseStudies of the same condition, open and under way.
- More trials run by St. Olavs HospitalThe 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Olavs Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Responsible party
- Sponsor
- Investigators
- Nils K Skjaervold, PhD, Principal investigator, Trondheim University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02765607
- Sponsor's protocol ID
- 2015/2019
- Status last verified
- Feb 2018
- First submitted
- 19 Apr 2016
- Last updated
- 7 Feb 2018
- 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 7 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circulatory Oscillations in Post Cardiac Surgery Patients
- ClinicalTrials.gov ID
- NCT02765607
- Acronym / sponsor ID
- 2015/2019
- Conditions
- Coronary Disease
- Keywords
- Blood circulation, Cardiac surgical procedures, Homeostasis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- St. Olavs HospitalUniversity, hospital or other
- Collaborators
- Norwegian University of Science and Technology
- Study start
- Mar 2016 (actual)
- Primary completion
- Dec 2017 (actual)
- Study completion
- Dec 2017 (actual)
- First posted
- 6 May 2016 (estimated)
- 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.
In this observational study investigators examine the presence of circulatory oscillations in blood pressure, heart rate, and doppler laser flow before and after planned cardiac surgery.
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
- Patients scheduled for routine coronary artery bypass graft (CABG) surgery.
Key inclusion criteria (1 listed)
- patients scheduled for routine coronary artery bypass graft (CABG) surgery, single procedure only
Key exclusion criteria (6 listed)
- no sinus or pacemaker rhythm
- ejection fraction below 0.5
- serious valvular disease
- right ventricular failure
- pulmonary hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Heart surgery | Procedure or surgery | – |
Primary outcome
Frequency and amplitude of oscillations of electrocardiogram (ECG)
Time frame: First day
analyzed by continuous wavelet transform
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 7 Feb 2018.
- 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.
Nils K Skjaervold, PhD principal investigator
Trondheim University Hospital
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 Disease, run by St. Olavs Hospital 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 1 inclusion and 6 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 7 Feb 2018. 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?
Frequency and amplitude of oscillations of electrocardiogram (ECG) (time frame: First day). 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 7 Feb 2018.