Observation and Prediction of Complications After Coronary Angiography — OPKAT  

Myocardial Ischemia Clinical Trial

Official title: Observation and Prediction of Complications After Coronary Angiography

Status Completed

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.

Clinical Trial Description

n/a

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

• NCT number: NCT00259194
• Study type: Interventional
• Source: Herning Hospital
• Status: Completed
• Phase: N/A
• Start date: December 2005
• Completion date: December 2007