Does Coronary Angiography Cause Cognitive Dysfunction?

NCT ID: NCT01428947

Last Updated: 2016-02-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-09-30

Study Completion Date

2012-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Coronary Heart Disease Heart Valve Diseases

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Coronary angiography

Patents scheduled for elective coronary angiography

Arterial approach

Intervention Type PROCEDURE

Randomization to right radial or femoral approach

Interventions

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Arterial approach

Randomization to right radial or femoral approach

Intervention Type PROCEDURE

Other Intervention Names

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Coronary arteriography

Eligibility Criteria

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Inclusion Criteria

* Elective coronary angiography irrespective of cause

Exclusion Criteria

* Previous CABG, language problems, not willing to participate
Minimum Eligible Age

35 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Karolinska Institutet

OTHER

Sponsor Role lead

Responsible Party

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Per Tornvall

Docent

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Per - Tornvall, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Karolinska Institutet

Locations

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Cardiology Clinic, Karolinska University Hospital

Stockholm, , Sweden

Site Status

Countries

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Sweden

References

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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.

Reference Type BACKGROUND
PMID: 21393589 (View on PubMed)

Other Identifiers

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KI-angio-2

Identifier Type: -

Identifier Source: org_study_id

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