ClinicalTrials.gov
ClinicalTrials.gov Menu

Does Coronary Angiography Cause Cognitive Dysfunction?

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.
ClinicalTrials.gov Identifier: NCT01428947
Recruitment Status : Completed
First Posted : September 5, 2011
Last Update Posted : February 24, 2016
Sponsor:
Information provided by (Responsible Party):
Per Tornvall, Karolinska Institutet

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
The purpose of the study is to study if coronary angiography cause cognitive dysfunction.

Condition or disease Intervention/treatment
Coronary Heart Disease Heart Valve Diseases Procedure: Arterial approach

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.

Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type : Observational
Actual Enrollment : 80 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Study of Cognitive Function Before and After Coronary Angiography
Study Start Date : September 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012
Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
Coronary angiography
Patents scheduled for elective coronary angiography
 Procedure: Arterial approach
Randomization to right radial or femoral approach
Other Name: Coronary arteriography


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   35 Years to 90 Years   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations 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 Posted: September 5, 2011    Key Record Dates
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