Clinical trial NCT00259194: Observation and Prediction of Complications After Coronary Angiography
Official title: Observation and Prediction of Complications After Coronary Angiography
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Arteriosclerosis
Myocardial Ischemia
Keywords: Coronary angiography
Complications
Observation
Lead sponsor: Herning Hospital
Sponsor class: OTHER
Collaborators: name: The Medical Research Fund of the County of Ringkøbing
First posted: 2005-11-29
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility 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.

Primary outcomes:
measure: Incidence of bleeding complications
timeFrame: 4 days
measure: Model to predict bleeding complications
timeFrame: 4 days
measure: Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications
timeFrame: 4 days
Secondary outcomes:
Other outcomes:
Locations:
city: Herning
country: Denmark
facility: Coronary Angiography Laboratory
city: Herning
country: Denmark
facility: Dept. of Med., Sect. of Cardology, Herning Hospital
Study officials:
affiliation: Dept. of Med., Section of Cardiol., Herning Hospital, DK-7400 Herning
name: Ole May, Dr.,Ph.D.
role: STUDY_CHAIR
References:
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.
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.