We are updating the design of this site. Learn more.
Show more
ClinicalTrials.gov
ClinicalTrials.gov Menu

Observation and Prediction of Complications After Coronary Angiography (OPKAT)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00259194
First Posted: November 29, 2005
Last Update Posted: June 11, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
The Medical Research Fund of the County of Ringkøbing
Information provided by:
Herning Hospital
  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
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Observation and Prediction of Complications After Coronary Angiography

Further study details as provided by Herning Hospital:

Primary Outcome Measures:
  • 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 ]

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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
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.
  Contacts and Locations
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
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00259194     History of Changes
Other Study ID Numbers: OPKAT
First Submitted: November 28, 2005
First Posted: November 29, 2005
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