Does Coronary Angiography Cause Cognitive Dysfunction?
This study has been completed.
Sponsor:
Karolinska Institutet
Information provided by (Responsible Party):
Per Tornvall, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01428947
First received: August 26, 2011
Last updated: February 23, 2016
Last verified: February 2016
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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| 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
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01428947
Please refer to this study by its ClinicalTrials.gov identifier: 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 |
| Study First Received: | August 26, 2011 |
| Last Updated: | February 23, 2016 |
Additional relevant MeSH terms:
|
Heart Diseases Coronary Disease Coronary Artery Disease Myocardial Ischemia Heart Valve Diseases |
Cardiovascular Diseases Vascular Diseases Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 25, 2017