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Completed

NCT Number: NCT01428947

Does Coronary Angiography Cause Cognitive Dysfunction?

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

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Key information

Conditions

Coronary Heart Disease Cardiovascular Diseases Coronary Disease Heart Diseases Heart Valve Diseases Myocardial Ischemia Vascular Diseases

Age range

35 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Cardiology Clinic, Karolinska University Hospital

Stockholm, 17176, Sweden

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Elective coronary angiography irrespective of cause

Exclusion criteria

  • Previous CABG, language problems, not willing to participate

Treatment and study plan

Arterial approach

Procedure

Randomization to right radial or femoral approach

Other names: Coronary arteriography

Primary outcomes

  1. 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

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

Study of Cognitive Function Before and After Coronary Angiography

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Sep 5, 2011
Registry last updated
Feb 24, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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