Coronary Heart DiseaseNCT01428947
Does Coronary Angiography Cause Cognitive Dysfunction?
An observational study of Coronary Heart Disease and Heart Valve Diseases, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
The purpose of the study is to study if coronary angiography cause cognitive dysfunction. Read more about this study
- Who is it for?
- Ages 35 to 90 years
- Conditions the study is for
- Coronary Heart Disease, Heart Valve Diseases
- What is being tested?
- Arterial approach
- Type of treatment
- Surgery or procedure
- How many people
- 80 participants
- Where
- 1 siteSweden
- Study dates
- Sep 2011to Jun 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients scheduled for elective coronary angiography at one center
Who may be able to join
- Elective coronary angiography irrespective of cause
Who cannot join
- Previous CABG, language problems, not willing to participate
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Cardiology Clinic, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: Study of Cognitive Function Before and After Coronary Angiography
The purpose of the study is to study if coronary angiography cause cognitive dysfunction.
Read the 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.
- Conditions
- Coronary Heart Disease, Heart Valve Diseases
- Being tested
- Arterial approach
- Medical subject headings
- Coronary Disease, Heart Valve Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial approachProcedure or surgery
Also called Coronary arteriography
Randomization to right radial or femoral approach
| Study group | Role | What they receive |
|---|---|---|
| Coronary angiography | Patents scheduled for elective coronary angiography Receives: Procedure: Arterial approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in cognitive dysfunction from baseline to two days after coronary angiography
The Montreal Cognitive Assesment test will be performed before, 2 and 30 days after coronary angiography
Measured: Baseline and two days
Secondary outcomes (1)
Number of patients with cerebral microemboli
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2011 (estimated)
- Study startSep 2011
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Per Tornvall, Karolinska Institutet
- Investigators
- Per - Tornvall, MD, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01428947
- Sponsor's protocol ID
- KI-angio-2
- Status last verified
- Feb 2016
- First submitted
- 26 Aug 2011
- Last updated
- 24 Feb 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Jurga J, Nyman J, Tornvall P, Mannila MN, Svenarud P, van der Linden J, Sarkar N. Cerebral microembolism during coronary angiography: a randomized comparison between femoral and radial arterial access. Stroke. 2011 May;42(5):1475-7. doi: 10.1161/STROKEAHA.110.608638. Epub 2011 Mar 10.
PubMed 21393589
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Cognitive Function Before and After Coronary Angiography
- ClinicalTrials.gov ID
- NCT01428947
- Acronym / sponsor ID
- KI-angio-2
- Conditions
- Coronary Heart Disease, Heart Valve Diseases
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Sep 2011
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 5 Sep 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to study if coronary angiography cause cognitive dysfunction.
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
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Coronary angiography | – | Procedure: Arterial approachPatents scheduled for elective coronary angiography |
Who may qualify
- Ages
- 35 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients scheduled for elective coronary angiography at one center
Key inclusion criteria (1 listed)
- Elective coronary angiography irrespective of cause
Key exclusion criteria (1 listed)
- Previous CABG, language problems, not willing to participate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Arterial approachAlso: Coronary arteriographyRandomization to right radial or femoral approach | Procedure or surgery | Coronary angiography |
Primary outcome
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
1 secondary outcome
Number of patients with cerebral microemboli
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2016.
- Background: PubMed 21393589Jurga J, Nyman J, Tornvall P, Mannila MN, Svenarud P, van der Linden J, Sarkar N. Cerebral microembolism during coronary angiography: a randomized comparison between femoral and radial arterial access. Stroke. 2011 May;42(5):1475-7. doi: 10.1161/STROKEAHA.110.608638. Epub 2011 Mar 10.
Related trials for Coronary Heart Disease
RecruitingPhase 2/3
Efficacy, Safety, and Pharmacokinetics of Vericiguat in Pediatric Participants With Heart Failure Due to Left Ventricular Systolic Dysfunction (MK-1242-036)
Heart Failure, Left Ventricular Systolic Dysfunction
RecruitingPhase 4
Efficacy and Safety of a Half-dose Bolus of r-SAK Prior to Primary PCI in ST-elevation Myocardial Infarction
ST Elevation Myocardial Infarction
Active, not recruitingPhase 4
Women's IschemiA TRial to Reduce Events In Non-ObstRuctive CAD
Coronary Artery Disease
Active, not recruiting
VOLT CE Mark Study
Atrial Arrhythmia, Atrial Fibrillation
Recruiting
SYMmetric Valve fraME Expansion To Reduce hYpoattenuated Leaflet Thickening After Balloon-expandable TAVI: the SYMMETRY Trial
Aortic Valve Stenosis and/or Insufficiency, Hypoattenuated Leaflet Thickening
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Per - Tornvall, MD, PhD principal investigator
Karolinska Institutet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Heart Disease and Heart Valve Diseases, run by Karolinska Institutet at 1 site in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Feb 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in cognitive dysfunction from baseline to two days after coronary angiography (time frame: Baseline and two days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01428947, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Feb 2016.