Coronary ArteriosclerosisOPKATNCT00259194
Observation and Prediction of Complications After Coronary Angiography
A study testing Moving and No Moving in people with Coronary Arteriosclerosis and Myocardial Ischemia, run by Herning Hospital at 2 sites in Denmark.
Trial summary
Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Arteriosclerosis, Myocardial Ischemia
- What is being tested?
- Moving and No Moving
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,000 participants
- Where
- 2 sitesDenmark
- Study dates
- Dec 2005to Dec 2007
- Phase
- Interventional
- 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
Who may be able to join
- Coronary angiography by the femoral access, where the arterial lumen is reached.
- Only attempted puncture at one side.
- Age >= 18 years.
Who cannot join
- Conditions that makes observation in the department impossible.
- Dementia or other reasons to expect lack of compliance.
- Previous participation in the project.
- Implanted vascular prothesis at puncture site.
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Coronary Angiography Laboratory
Herning, 7400
Dept. of Med., Sect. of Cardology, Herning Hospital
Herning, 7400
About this study
Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. The investigators apply pressure over the puncture site using a sand bag in the first hour. The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). In the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation.
The study has three aims:
Read more
- To establish the incidence of bleeding complications:
- Frequency of hematoma (> 5 cm)
- Frequency of pseudoaneurysms
- Frequency of bleeding demanding surgery
- Frequency of bleeding demanding transfusion
- Establish a model to predict in wich patient to expect a bleeding complication.
- Assess if the alternative observation is associated with more bleeding complications compared to standard observation.
- Conditions
- Coronary Arteriosclerosis, Myocardial Ischemia
- Being tested
- Moving, No Moving
- Keywords
- Coronary angiography, Complications, Observation
- Medical subject headings
- Coronary Artery Disease, Myocardial Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MovingBehavioural
The patients are allowed to lift their head, arms and legs during the 2 hours.
No MovingBehavioural
The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours.
| Study group | Role | What they receive |
|---|---|---|
| Alternative Observation | Active comparator | Moving in bed during observation after coronary angiography Receives: Behavioral: Moving |
| Standard Observation | Experimental | No moving in bed during observation after coronary angiography Receives: Behavioral: No Moving |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of bleeding complications
Measured: 4 days
Model to predict bleeding complications
Measured: 4 days
Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2005 (estimated)
- Study startDec 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Coronary ArteriosclerosisStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Herning Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- The Medical Research Fund of the County of Ringkøbing
- Investigators
- Ole May, Dr.,Ph.D., Study chair, Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00259194
- Sponsor's protocol ID
- OPKAT
- Acronym
- OPKAT
- Status last verified
- Jun 2009
- First submitted
- 28 Nov 2005
- Last updated
- 11 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
May O, Schlosser H, Skytte L. A high blood pressure predicts bleeding complications and a longer hospital stay after elective coronary angiography using the femoral approach. J Interv Cardiol. 2009 Apr;22(2):175-8. doi: 10.1111/j.1540-8183.2009.00427.x. Epub 2009 Feb 24.
PubMed 19245381May O, Schlosser H, Skytte L. A randomized trial assessing the influence of lying still or being allowed to move in the observation period following coronary angiography using the femoral approach. J Interv Cardiol. 2008 Aug;21(4):347-9. doi: 10.1111/j.1540-8183.2008.00359.x. Epub 2008 May 29.
PubMed 18513345
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observation and Prediction of Complications After Coronary Angiography
- ClinicalTrials.gov ID
- NCT00259194
- Acronym / sponsor ID
- OPKAT / OPKAT
- Conditions
- Coronary Arteriosclerosis, Myocardial Ischemia
- Keywords
- Coronary angiography, Complications, Observation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Herning HospitalUniversity, hospital or other
- Collaborators
- The Medical Research Fund of the County of Ringkøbing
- Study start
- Dec 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Nov 2005 (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.
Coronary angiography via the femoral artery is regarded as a safe procedure, but bleeding complications are often seen. To avoid/reduce bleeding complications digital compression is applied in the area of puncture during approximately 20 minutes and the patient is in the investigators' department observed in bed for 2 hours. The investigators apply pressure over the puncture site using a sand bag in the first hour. The patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours (standard observation). In the present study the patients are randomized between standard observation and an alternative observation, where the patients are allowed to lift their head, arms and legs during the 2 hours, otherwise as standard observation.
The study has three aims:
- To establish the incidence of bleeding complications:
- Frequency of hematoma (> 5 cm)
- Frequency of pseudoaneurysms
- Frequency of bleeding demanding surgery
- Frequency of bleeding demanding transfusion
- Establish a model to predict in wich patient to expect a bleeding complication.
- Assess if the alternative observation is associated with more bleeding complications compared to standard observation.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Alternative Observation | Active comparator | Behavioral: MovingMoving in bed during observation after coronary angiography |
| Standard Observation | Experimental | Behavioral: No MovingNo moving in bed during observation after coronary angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Coronary angiography by the femoral access, where the arterial lumen is reached.
- Only attempted puncture at one side.
- Age >= 18 years.
Key exclusion criteria (4 listed)
- Conditions that makes observation in the department impossible.
- Dementia or other reasons to expect lack of compliance.
- Previous participation in the project.
- Implanted vascular prothesis at puncture site.
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 |
|---|---|---|
| MovingThe patients are allowed to lift their head, arms and legs during the 2 hours. | Behavioural | Alternative Observation |
| No MovingThe patients are told not to move, to keep their legs and upper arms down and not to lift the head from the pillow in these 2 hours. | Behavioural | Standard Observation |
Primary outcome
Incidence of bleeding complications
Time frame: 4 days
Model to predict bleeding complications
Time frame: 4 days
Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
Time frame: 4 days
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 11 Jun 2009.
- Results publication: PubMed 19245381May O, Schlosser H, Skytte L. A high blood pressure predicts bleeding complications and a longer hospital stay after elective coronary angiography using the femoral approach. J Interv Cardiol. 2009 Apr;22(2):175-8. doi: 10.1111/j.1540-8183.2009.00427.x. Epub 2009 Feb 24.
- Results publication: PubMed 18513345May O, Schlosser H, Skytte L. A randomized trial assessing the influence of lying still or being allowed to move in the observation period following coronary angiography using the femoral approach. J Interv Cardiol. 2008 Aug;21(4):347-9. doi: 10.1111/j.1540-8183.2008.00359.x. Epub 2008 May 29.
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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.
Ole May, Dr.,Ph.D. study chair
Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Moving and No Moving in people with Coronary Arteriosclerosis and Myocardial Ischemia, run by Herning Hospital at 2 sites in Denmark.
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 3 inclusion and 4 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 11 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Denmark. 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?
Incidence of bleeding complications (time frame: 4 days). The study lists 3 primary outcomes in all. 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 NCT00259194, which also lists 2 linked publications.
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 11 Jun 2009.