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CompletedNCT00259194OPKATUpdated Jun 11, 2009

Observation and Prediction of Complications After Coronary Angiography

An interventional study of Moving and No Moving in Coronary Arteriosclerosis and Myocardial Ischemia, sponsored by Herning Hospital. Completed at 2 sites in Denmark. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-06-11.

Sponsored by Herning Hospital · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.
02

Conditions studied

  • Coronary Arteriosclerosis
  • Myocardial Ischemia

Keywords

  • Coronary angiography
  • Complications
  • Observation
03

In context

Myocardial Ischemia

3,233 studies on the registry are indexed under Myocardial Ischemia; 396 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 120 across 1,895 interventional studies indexed under Myocardial Ischemia.

Browse Myocardial Ischemia studies →

Lead sponsor

Herning Hospital is the lead sponsor of 19 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
1,000 participants (estimated)

Study arms

  • Active comparator
    Alternative Observation

    Moving in bed during observation after coronary angiography

    Behavioral: Moving

  • Experimental
    Standard Observation

    No moving in bed during observation after coronary angiography

    Behavioral: No Moving

Interventions

  • BehavioralMoving

    The patients are allowed to lift their head, arms and legs during the 2 hours.

  • BehavioralNo 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.

06

What researchers measure

Primary outcomes

  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

07

Study locations

2 sites
  • Coronary Angiography Laboratory
    Herning, 7400, Denmark
  • Dept. of Med., Sect. of Cardology, Herning Hospital
    Herning, 7400, Denmark
08

References and documents

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 19245381 ↗
  • 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. PubMed 18513345 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 11, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00259194
Lead sponsor
Herning Hospital
Collaborators
The Medical Research Fund of the County of Ringkøbing
First posted
Nov 29, 2005
Start date
Dec 2005
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Jun 11, 2009

Study contacts

Ole May, Dr.,Ph.D.
study chair · Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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