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Does Coronary Angiography Cause Cognitive Dysfunction?

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01428947
First Posted: September 5, 2011
Last Update Posted: February 24, 2016
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.
Information provided by (Responsible Party):
Per Tornvall, Karolinska Institutet
  Purpose
The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

Condition Intervention
Coronary Heart Disease Heart Valve Diseases Procedure: Arterial approach

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Cognitive Function Before and After Coronary Angiography

Further study details as provided by Per Tornvall, Karolinska Institutet:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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.


Enrollment: 80
Study Start Date: September 2011
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Coronary angiography
Patents scheduled for elective coronary angiography
Procedure: Arterial approach
Randomization to right radial or femoral approach
Other Name: Coronary arteriography

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients scheduled for elective coronary angiography at one center
Criteria

Inclusion Criteria:

  • Elective coronary angiography irrespective of cause

Exclusion Criteria:

  • Previous CABG, language problems, not willing to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01428947


Locations
Sweden
Cardiology Clinic, Karolinska University Hospital
Stockholm, Sweden, 17176
Sponsors and Collaborators
Karolinska Institutet
Investigators
Principal Investigator: Per - Tornvall, MD, PhD Karolinska Institutet
  More Information

Publications:
Responsible Party: Per Tornvall, Docent, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01428947     History of Changes
Other Study ID Numbers: KI-angio-2
First Submitted: August 26, 2011
First Posted: September 5, 2011
Last Update Posted: February 24, 2016
Last Verified: February 2016

Additional relevant MeSH terms:
Heart Diseases
Coronary Disease
Coronary Artery Disease
Myocardial Ischemia
Cognitive Dysfunction
Heart Valve Diseases
Cardiovascular Diseases
Vascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Cognition Disorders
Neurocognitive Disorders
Mental Disorders