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Observation and Prediction of Complications After Coronary Angiography (OPKAT)

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ClinicalTrials.gov Identifier: NCT00259194
Recruitment Status : Completed
First Posted : November 29, 2005
Last Update Posted : June 11, 2009
Sponsor:
Collaborator:
The Medical Research Fund of the County of Ringkøbing
Information provided by:
Herning Hospital

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:

  1. 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
  2. Establish a model to predict in wich patient to expect a bleeding complication.
  3. Assess if the alternative observation is associated with more bleeding complications compared to standard observation.

Condition or disease Intervention/treatment Phase
Coronary Arteriosclerosis Myocardial Ischemia Behavioral: Moving Behavioral: No Moving Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Observation and Prediction of Complications After Coronary Angiography
Study Start Date : December 2005
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Arm Intervention/treatment
Active Comparator: Alternative Observation
Moving in bed during observation after coronary angiography
Behavioral: Moving
The patients are allowed to lift their head, arms and legs during the 2 hours.

Experimental: Standard Observation
No moving in bed during observation after coronary angiography
Behavioral: No Moving
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 Measures :
  1. Incidence of bleeding complications [ Time Frame: 4 days ]
  2. Model to predict bleeding complications [ Time Frame: 4 days ]
  3. Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications [ Time Frame: 4 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Coronary angiography by the femoral access, where the arterial lumen is reached.
  2. Only attempted puncture at one side.
  3. Age >= 18 years.

Exclusion Criteria:

  1. Conditions that makes observation in the department impossible.
  2. Dementia or other reasons to expect lack of compliance.
  3. Previous participation in the project.
  4. Implanted vascular prothesis at puncture site.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00259194


Locations
Denmark
Coronary Angiography Laboratory
Herning, Denmark, 7400
Dept. of Med., Sect. of Cardology, Herning Hospital
Herning, Denmark, 7400
Sponsors and Collaborators
Herning Hospital
The Medical Research Fund of the County of Ringkøbing
Investigators
Study Chair: Ole May, Dr.,Ph.D. Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning

Publications of Results:
ClinicalTrials.gov Identifier: NCT00259194     History of Changes
Other Study ID Numbers: OPKAT
First Posted: November 29, 2005    Key Record Dates
Last Update Posted: June 11, 2009
Last Verified: June 2009

Keywords provided by Herning Hospital:
Coronary angiography
Complications
Observation

Additional relevant MeSH terms:
Ischemia
Myocardial Ischemia
Coronary Artery Disease
Arteriosclerosis
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Coronary Disease
Arterial Occlusive Diseases