Coronary Artery DiseaseNCT02001090
Vascular Function on the First Day After Cardiac Surgery
An observational study of Coronary Artery Disease, run by Norwegian University of Science and Technology at 1 site in Norway.
Trial summary
This study examines the flow mediated dilation (FMD) of the brachial artery before and after cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough obstructing blood flow with a cuff around the forearm for five minutes. Read more about this study
- Who is it for?
- Ages 30 years and older
- Conditions the study is for
- Coronary Artery Disease
- How many people
- 25 participants
- Where
- 1 siteNorway
- Study dates
- Dec 2013to 29 Apr 2014
- 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 30 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing coronary artery bypass surgery.
Who may be able to join
- admitted for coronary artery bypass surgery
Who cannot join
- Ongoing treatment with nitrates or RAAS inhibiting drugs
- unstable coronary syndrome
- unstable circulation/shock
- renal failure
- hepatic failure
- autoimmune or inflammatory disease
- untreated hypertension.
Trial locations and contacts
1 site in 1 country.
About this study
This study examines the flow mediated dilation (FMD) of the brachial artery before and after cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured before surgery and on the first morning after the operation.
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac Surgical Procedures, Heart-Lung Machine, Coronary Artery Bypass, Brachial Artery, Vasodilation, Regional Blood Flow, Ultrasonography
- Medical subject headings
- Coronary Artery Disease, Aneurysm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| CABG patients | Patients undergoing cardiac surgery for coronary artery disease with the use of heart-lung machine in St Olavs Hospital Trondheim University Hospital. |
What is being measured
The primary outcome is the main question the study is designed to answer.
flow mediated dilation of the brachial artery
Transitory change in FMD as a consequence of cardiac surgery with use of extra corporal circulation.
Measured: one day
Secondary outcomes (1)
Reactive hyperemia
Transitory change in reactive hyperemia after five minutes of occlusion of forearm blood flow as a consequence of cardiac surgery with the use of extra corporal circulation.
Measured: one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2013 (estimated)
- Study startDec 2013
- Primary completion29 Apr 2014
- Study completion29 Apr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Artery DiseaseStudies of the same condition, open and under way.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 25 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., Study director, Department of Cardiothoracic Anesthesiolgy and Intensive Care, St. Olav's Hospital, Trondheim, Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001090
- Sponsor's protocol ID
- REK nr 2013/1758
- Status last verified
- Sep 2017
- First submitted
- 27 Nov 2013
- Last updated
- 19 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Dedichen HH, Hisdal J, Skogvoll E, Aadahl P, Kirkeby-Garstad I. Reduced reactive hyperemia may explain impaired flow-mediated dilation after on-pump cardiac surgery. Physiol Rep. 2017 May;5(10):e13274. doi: 10.14814/phy2.13274.
PubMed 28554963
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vascular Function on the First Day After Cardiac Surgery
- ClinicalTrials.gov ID
- NCT02001090
- Acronym / sponsor ID
- REK nr 2013/1758
- Conditions
- Coronary Artery Disease
- Keywords
- Cardiac Surgical Procedures, Heart-Lung Machine, Coronary Artery Bypass, Brachial Artery, Vasodilation, Regional Blood Flow, Ultrasonography
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Norwegian University of Science and TechnologyUniversity, hospital or other
- Collaborators
- St. Olavs Hospital
- Study start
- Dec 2013 (actual)
- Primary completion
- 29 Apr 2014 (actual)
- Study completion
- 29 Apr 2014 (actual)
- First posted
- 4 Dec 2013 (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.
This study examines the flow mediated dilation (FMD) of the brachial artery before and after cardiac surgery. FMD is measured with ultrasound technique. Increased flow is achieved trough obstructing blood flow with a cuff around the forearm for five minutes. FMD is measured before surgery and on the first morning after the operation.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CABG patients | – | –Patients undergoing cardiac surgery for coronary artery disease with the use of heart-lung machine in St Olavs Hospital Trondheim University Hospital. |
Who may qualify
- Ages
- 30 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing coronary artery bypass surgery.
Key inclusion criteria (1 listed)
- admitted for coronary artery bypass surgery
Key exclusion criteria (7 listed)
- Ongoing treatment with nitrates or RAAS inhibiting drugs
- unstable coronary syndrome
- unstable circulation/shock
- renal failure
- hepatic failure
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
flow mediated dilation of the brachial artery
Time frame: one day
Transitory change in FMD as a consequence of cardiac surgery with use of extra corporal circulation.
1 secondary outcome
Reactive hyperemia
Time frame: one 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 19 Sep 2017.
- Results publication: PubMed 28554963Dedichen HH, Hisdal J, Skogvoll E, Aadahl P, Kirkeby-Garstad I. Reduced reactive hyperemia may explain impaired flow-mediated dilation after on-pump cardiac surgery. Physiol Rep. 2017 May;5(10):e13274. doi: 10.14814/phy2.13274.
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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. study director
Department of Cardiothoracic Anesthesiolgy and Intensive Care, St. Olav's Hospital, Trondheim, Norway
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 Artery Disease, 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 1 inclusion and 7 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 19 Sep 2017. 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?
flow mediated dilation of the brachial artery (time frame: one day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02001090, which also lists 1 linked publication.
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 19 Sep 2017.