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NCT01428947 Clinical Trial

Does Coronary Angiography Cause Cognitive Dysfunction?

Coronary Heart Disease Clinical Trial

Official title:
Study of Cognitive Function Before and After Coronary Angiography

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01428947
Other study ID # KI-angio-2
Secondary ID
Status Completed
Phase N/A
First received August 26, 2011
Last updated February 23, 2016
Start date September 2011
Est. completion date June 2012

Study information
Verified date February 2016
Source Karolinska Institutet
Contact n/a
Is FDA regulated No
Health authority Sweden: Institutional Review Board
Study type Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 80
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group 35 Years to 90 Years
Eligibility Inclusion Criteria:

- Elective coronary angiography irrespective of cause

Exclusion Criteria:

- Previous CABG, language problems, not willing to participate

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Arterial approach
Randomization to right radial or femoral approach

Locations
Country Name City State
Sweden Cardiology Clinic, Karolinska University Hospital Stockholm

Sponsors (1)
Lead Sponsor Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

References & Publications (1)

Jurga J, Nyman J, Tornvall P, Mannila MN, Svenarud P, van der Linden J, Sarkar N. Cerebral microembolism during coronary angiography: a randomized comparison between femoral and radial arterial access. Stroke. 2011 May;42(5):1475-7. doi: 10.1161/STROKEAHA.110.608638. Epub 2011 Mar 10. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in cognitive dysfunction from baseline to two days after coronary angiography The Montreal Cognitive Assesment test will be performed before, 2 and 30 days after coronary angiography Baseline and two days Yes
Secondary Number of patients with cerebral microemboli 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. Baseline Yes
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