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Does Coronary Angiography Cause Cognitive Dysfunction?

This study is not yet open for participant recruitment.
Verified September 2011 by Karolinska Institutet
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
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 80
Study Start Date: September 2011
Estimated Study Completion Date: May 2012
Estimated Primary Completion Date: February 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

Ages Eligible for Study:   35 Years to 90 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01428947

Contacts
Contact: Per - Tornvall, MD, PhD +46-8-51772951 ext - per.tornvall@karolinska.se

Locations
Sweden
Cardiology Clinic, Karolinska University Hospital Not yet recruiting
Stockholm, Sweden, 17176
Contact: Per - Tornvall, MD, PhD     +46-8-51772951 ext -     per.tornvall@karolinska.se    
Sub-Investigator: Nondita - Sarkar, MD, PhD            
Sub-Investigator: Juliane - Jurga, MD            
Sub-Investigator: Jan - van der Linden, MD, PhD            
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
Study First Received: August 26, 2011
Last Updated: September 2, 2011
Health Authority: Sweden: Institutional Review Board

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Heart Diseases
Heart Valve Diseases
 Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases

ClinicalTrials.gov processed this record on May 22, 2013