Does Coronary Angiography Cause Cognitive Dysfunction?
This study is not yet open for participant recruitment.
Verified September 2011 by Karolinska Institutet
Sponsor:
Karolinska Institutet
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
| Tracking Information | |||||
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| First Received Date ICMJE | August 26, 2011 | ||||
| Last Updated Date | September 2, 2011 | ||||
| Start Date ICMJE | September 2011 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01428947 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
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. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Does Coronary Angiography Cause Cognitive Dysfunction? | ||||
| Official Title ICMJE | Study of Cognitive Function Before and After Coronary Angiography | ||||
| Brief Summary | The purpose of the study is to study if coronary angiography cause cognitive dysfunction. |
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| 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. |
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Case-Only Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients scheduled for elective coronary angiography at one center |
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| Condition ICMJE |
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| Intervention ICMJE | Procedure: Arterial approach
Randomization to right radial or femoral approach
Other Name: Coronary arteriography |
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| Study Group/Cohort (s) | Coronary angiography
Patents scheduled for elective coronary angiography
Intervention: Procedure: Arterial approach |
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| Publications * | 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. Epub 2011 Mar 10. | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Not yet recruiting | ||||
| Estimated Enrollment ICMJE | 80 | ||||
| Estimated Completion Date | May 2012 | ||||
| Estimated Primary Completion Date | February 2012 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 35 Years to 90 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE |
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| Location Countries ICMJE | Sweden | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01428947 | ||||
| Other Study ID Numbers ICMJE | KI-angio-2 | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Per Tornvall, Karolinska Institutet | ||||
| Study Sponsor ICMJE | Karolinska Institutet | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | Karolinska Institutet | ||||
| Verification Date | September 2011 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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