Does Coronary Angiography Cause Cognitive Dysfunction?

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01428947
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : February 24, 2016
Information provided by (Responsible Party):
Per Tornvall, Karolinska Institutet

August 26, 2011
September 5, 2011
February 24, 2016
September 2011
June 2012   (Final data collection date for primary outcome measure)
Change in cognitive dysfunction from baseline to two days after coronary angiography [ Time Frame: Baseline and two days ]
The Montreal Cognitive Assesment test will be performed before, 2 and 30 days after coronary angiography
Same as current
Complete list of historical versions of study NCT01428947 on Archive Site
Number of patients with cerebral microemboli [ Time Frame: 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.
Same as current
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Does Coronary Angiography Cause Cognitive Dysfunction?
Study of Cognitive Function Before and After Coronary Angiography
The purpose of the study is to study if coronary angiography cause cognitive dysfunction.
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.
Observational Model: Case-Only
Time Perspective: Prospective
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Probability Sample
Patients scheduled for elective coronary angiography at one center
  • Coronary Heart Disease
  • Heart Valve Diseases
Procedure: Arterial approach
Randomization to right radial or femoral approach
Other Name: Coronary arteriography
Coronary angiography
Patents scheduled for elective coronary angiography
Intervention: Procedure: Arterial approach
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.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 2012
June 2012   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Elective coronary angiography irrespective of cause

Exclusion Criteria:

  • Previous CABG, language problems, not willing to participate
Sexes Eligible for Study: All
35 Years to 90 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
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Per Tornvall, Karolinska Institutet
Karolinska Institutet
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Principal Investigator: Per - Tornvall, MD, PhD Karolinska Institutet
Karolinska Institutet
February 2016