Observation and Prediction of Complications After Coronary Angiography

Myocardial Ischemia Clinical Trial

— OPKAT  

Official title:

Observation and Prediction of Complications After Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00259194
• Other study ID #: OPKAT
• Status: Completed
• Phase: N/A
• First received: November 28, 2005
• Last updated: June 8, 2009
• Start date: December 2005
• Est. completion date: December 2007

Study information

• Verified date: June 2009
• Source: Herning Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Regional Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1000
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Arteriosclerosis
• Coronary Arteriosclerosis
• Coronary Artery Disease
• Myocardial Ischemia

Intervention

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

Locations

Country	Name	City	State
Denmark	Coronary Angiography Laboratory	Herning
Denmark	Dept. of Med., Sect. of Cardology, Herning Hospital	Herning

Sponsors (2)

Lead Sponsor	Collaborator
Herning Hospital	The Medical Research Fund of the County of Ringkøbing

Country where clinical trial is conducted

Denmark, 

References & Publications (2)

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. E — View 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.15 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of bleeding complications		4 days	Yes
Primary	Model to predict bleeding complications		4 days	Yes
Primary	Assess if lying still in bed the first 2 hours after angiography affect the incidence of bleeding complications		4 days	Yes