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Observation and Prediction of Complications After Coronary Angiography (OPKAT)

This study has been completed.
Sponsor:
Collaborator:
The Medical Research Fund of the County of Ringkøbing
Information provided by:
Herning Hospital
ClinicalTrials.gov Identifier:
NCT00259194
First received: November 28, 2005
Last updated: June 8, 2009
Last verified: June 2009
History of Changes
  Purpose

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 Intervention
Coronary Arteriosclerosis
Myocardial Ischemia
 Behavioral: Moving
Behavioral: No Moving

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Observation and Prediction of Complications After Coronary Angiography

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Herning Hospital:

Primary Outcome Measures:
  • Incidence of bleeding complications [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • Model to predict bleeding complications [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]
  • Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications [ Time Frame: 4 days ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 1000
Study Start Date: December 2005
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00259194

Locations
Denmark
Dept. of Med., Sect. of Cardology, Herning Hospital
Herning, Denmark, 7400
Coronary Angiography Laboratory
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
  More Information

Publications:

ClinicalTrials.gov Identifier: NCT00259194     History of Changes
Other Study ID Numbers: OPKAT
Study First Received: November 28, 2005
Last Updated: June 8, 2009
Health Authority: Denmark: The Regional Committee on Biomedical Research Ethics

Keywords provided by Herning Hospital:
Coronary angiography
Complications
Observation

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

ClinicalTrials.gov processed this record on May 19, 2013