Does Coronary Angiography Cause Cognitive Dysfunction?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Karolinska Institutet.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Per Tornvall, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01428947
First received: August 26, 2011
Last updated: September 2, 2011
Last verified: September 2011

August 26, 2011
September 2, 2011
September 2011
February 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 ] [ Designated as safety issue: Yes ]
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 ClinicalTrials.gov Archive Site
Number of patients with cerebral microemboli [ Time Frame: Baseline ] [ Designated as safety issue: Yes ]
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
Not Provided
Not Provided
 
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
Observational Model: Case-Only
Time Perspective: Prospective
Not Provided
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
80
May 2012
February 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
Both
35 Years to 90 Years
No
Contact: Per - Tornvall, MD, PhD +46-8-51772951 ext - per.tornvall@karolinska.se
Sweden
 
NCT01428947
KI-angio-2
No
Per Tornvall, Karolinska Institutet
Karolinska Institutet
Not Provided
Principal Investigator: Per - Tornvall, MD, PhD Karolinska Institutet
Karolinska Institutet
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP