Does Coronary Angiography Cause Cognitive Dysfunction?

Completed

• Conditions: Coronary Heart Disease; Heart Valve Diseases
• Interventions: Procedure: Arterial approach

• Registration Number: NCT01428947
• Lead Sponsor: Karolinska Institutet

Brief Summary

The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

Detailed Description

We have previously shown, using transcranial doppler, that coronary angiography cause cerebral microembolism. Cerebral microemboli were more common using the radial than femoral approach. Previously, cerebral microembolism has been associated with new cerebral lesions on MRI. The clinical significance of these new lesions is not determined. The primary aim of this pilot study is to see if coronary angiography cause cognitive dysfunction determined by the MoCA-test. A secondary aim is to relate cognitive dysfunction to cerebral microembolism measured by transcranial doppler. A third aim is to study potential differences between the femoral and radial approaches.

Study Timeline

• Study First Submitted: 2011-08-26
• Study Start: 2011-09
• Study First Submitted QC: 2011-09-02
• Study First Posted: 2011-09-05
• Primary Completion: 2012-06
• Study Completion: 2012-06
• Status Verified: 2016-02
• Last Update Submitted: 2016-02-23
• Last Update Posted: 2016-02-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Elective coronary angiography irrespective of cause

Exclusion Criteria

• Previous CABG, language problems, not willing to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Coronary angiography	Arterial approach	Patents scheduled for elective coronary angiography

Primary Outcome Measures

Name	Time	Method
Change in cognitive dysfunction from baseline to two days after coronary angiography	Baseline and two days	The Montreal Cognitive Assesment test will be performed before, 2 and 30 days after coronary angiography

Secondary Outcome Measures

Name	Time	Method
Number of patients with cerebral microemboli	Baseline	Cerebral microembolism will be studied by transcraniell doppler at the time of angiography. Findings will be related to change in cognitive function between baseline and two days.

Trial Locations

Locations (1)

Cardiology Clinic, Karolinska University Hospital; 🇸🇪 Stockholm, Sweden