Observation and Prediction of Complications After Coronary Angiography (OPKAT)
Primary Purpose
Coronary Arteriosclerosis, Myocardial Ischemia
Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Moving
No Moving
Sponsored by
About this trial
This is an interventional prevention trial for Coronary Arteriosclerosis focused on measuring Coronary angiography, Complications, Observation
Eligibility Criteria
Inclusion Criteria: Coronary angiography by the femoral access, where the arterial lumen is reached. Only attempted puncture at one side. Age >= 18 years. Exclusion Criteria: 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.
Sites / Locations
- Coronary Angiography Laboratory
- Dept. of Med., Sect. of Cardology, Herning Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Alternative Observation
Standard Observation
Arm Description
Moving in bed during observation after coronary angiography
No moving in bed during observation after coronary angiography
Outcomes
Primary Outcome Measures
Incidence of bleeding complications
Model to predict bleeding complications
Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
Secondary Outcome Measures
Full Information
NCT ID
NCT00259194
First Posted
November 28, 2005
Last Updated
June 8, 2009
Sponsor
Herning Hospital
Collaborators
The Medical Research Fund of the County of Ringkøbing
1. Study Identification
Unique Protocol Identification Number
NCT00259194
Brief Title
Observation and Prediction of Complications After Coronary Angiography
Acronym
OPKAT
Official Title
Observation and Prediction of Complications After Coronary Angiography
Study Type
Interventional
2. Study Status
Record Verification Date
June 2009
Overall Recruitment Status
Completed
Study Start Date
December 2005 (undefined)
Primary Completion Date
December 2007 (Actual)
Study Completion Date
December 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Herning Hospital
Collaborators
The Medical Research Fund of the County of Ringkøbing
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Coronary Arteriosclerosis, Myocardial Ischemia
Keywords
Coronary angiography, Complications, Observation
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Alternative Observation
Arm Type
Active Comparator
Arm Description
Moving in bed during observation after coronary angiography
Arm Title
Standard Observation
Arm Type
Experimental
Arm Description
No moving in bed during observation after coronary angiography
Intervention Type
Behavioral
Intervention Name(s)
Moving
Intervention Description
The patients are allowed to lift their head, arms and legs during the 2 hours.
Intervention Type
Behavioral
Intervention Name(s)
No Moving
Intervention Description
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.
Primary Outcome Measure Information:
Title
Incidence of bleeding complications
Time Frame
4 days
Title
Model to predict bleeding complications
Time Frame
4 days
Title
Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
Time Frame
4 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Coronary angiography by the femoral access, where the arterial lumen is reached.
Only attempted puncture at one side.
Age >= 18 years.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ole May, Dr.,Ph.D.
Organizational Affiliation
Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning
Official's Role
Study Chair
Facility Information:
Facility Name
Coronary Angiography Laboratory
City
Herning
ZIP/Postal Code
7400
Country
Denmark
Facility Name
Dept. of Med., Sect. of Cardology, Herning Hospital
City
Herning
ZIP/Postal Code
7400
Country
Denmark
12. IPD Sharing Statement
Citations:
PubMed Identifier
19245381
Citation
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.
Results Reference
result
PubMed Identifier
18513345
Citation
May 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.
Results Reference
result
Learn more about this trial
Observation and Prediction of Complications After Coronary Angiography
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