AtherosclerosisNCT03685006
Atherosclerosis and Acute Ischemic Stroke Study
An observational study of Atherosclerosis and Inflammation, run by Oslo University Hospital at 1 site in Norway.
Trial summary
A significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaque at the carotid bifurcation. It is now wellknown that inflammation plays a key role in atherogenesis and plaque destabilization. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atherosclerosis, Inflammation, Ischemic Stroke
- How many people
- 500 participants
- Where
- 1 siteNorway
- Study dates
- 1 Jan 2009to 1 Jan 2030
- How long will I take part?
- 1 Year
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with carotid atherosclerosis and/ or cerebrovascular symptoms/ disease.
Who may be able to join
- All patients with an atherosclerotic carotid stenosis >50% admitting one of the study centres as an in-patient or an out-patient will be considered for inclusion.
- Acute stroke patients treated with thrombectomy at Oslo University Hospital will be included even though the carotid stenosis is < 50%.
Who cannot join
- Malign disease
- Inflammatory disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Carotid Atherosclerosis, Inflammation and Ischemic Stroke
A significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaque at the carotid bifurcation. It is now wellknown that inflammation plays a key role in atherogenesis and plaque destabilization. However the identification and characterization of the different inflammatory factors, as well as their relative importance, have not been clarified. This main aim of this study is to identify new risk markers for atherosclerosis and to characterize more precise methods for detection of the unstable carotid plaque with increased stroke-risk.
Read the detailed description
This project include patients with asymptomatic and symptomatic carotid stenosis >50%. Patients with acute ischemic stroke will also be included with carotid artery stenosis <50% (study 3). The patient group will undergo a clinical neurological examination, ultrasound of the neck-arteries and a blood sample. The majority will also have a CT-angiography of the neck arteries and a cerebral MRI or CT. Carotid plaques removed by surgery (carotid end-arterectomy) and thrombs removed by thrombectomy will undergo histological analyses.
Study 1:
Plasma markers will be analysed and compared to clinical symptoms, ultrasound assessment of the plaque, cerebral MRI (or CT).
Study 2:
Results from advanced ultrasound of the carotid plaque including assessment of plaque morphology will be compared to histology of the removed plaque. Plasma markers and clinic will be related to the findings. The correlation between the different diagnostic modalities and the histologic conclusion will be assessed.
Study 3:
This study focus on plasma markers in an acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source. Thrombi removed from the cerebral artery by thrombectomy will undergo histological analysis and the results will be compared to plasma markers and stroke aetiology.
- Conditions
- Atherosclerosis, Inflammation, Ischemic Stroke
- Medical subject headings
- Atherosclerosis, Inflammation, Ischemic Stroke
What is being measured
The primary outcome is the main question the study is designed to answer.
Plasma markers and advanced ultrasound of neck arteries to detect plaque instability, predict stroke risk and correlation to stroke aetiology.
Blood test, ultrasound, cerebral MRI, clinical assessment
Measured: one year
Secondary outcomes (3)
Plasma markers to predict plaque instability
Blood test, ultrasound, cerebral MRI
Measured: At inclusion
Advanced ultrasound for detection of carotid plaque instability
Ultrasound, blood test, cerebral MRI, histology of carotid artery plaques
Measured: At inclusion and after one year
Plasma markers to determine correlation of acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source
Blood tests, ultrasound of neck arteries, cerebral MRI, histology of removed cerebral thrombi
Measured: At inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2018
- Study start1 Jan 2009
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AtherosclerosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
- Target duration
- 1 Year
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Oslo, University Hospital, Akershus, Ostfold Hospital Trust, Vestre Viken Hospital Trust
- Responsible party
- Principal investigator, Mona Skjelland, Oslo University Hospital
- Investigators
- Mona Skjelland, MD/postdoc, Principal investigator, Oslo University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03685006
- Sponsor's protocol ID
- REK 2009/5237
- Status last verified
- Apr 2022
- First submitted
- 10 Aug 2018
- Last updated
- 25 Apr 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Carotid Atherosclerosis, Inflammation and Ischemic Stroke
- ClinicalTrials.gov ID
- NCT03685006
- Acronym / sponsor ID
- REK 2009/5237
- Conditions
- Atherosclerosis, Inflammation, Ischemic Stroke
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- University of Oslo, University Hospital, Akershus, Ostfold Hospital Trust, Vestre Viken Hospital Trust
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Jan 2030 (estimated)
- First posted
- 26 Sep 2018 (actual)
- 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.
A significant proportion of strokes are thromboembolic in nature, arising from atherosclerotic plaque at the carotid bifurcation. It is now wellknown that inflammation plays a key role in atherogenesis and plaque destabilization. However the identification and characterization of the different inflammatory factors, as well as their relative importance, have not been clarified. This main aim of this study is to identify new risk markers for atherosclerosis and to characterize more precise methods for detection of the unstable carotid plaque with increased stroke-risk.
Detailed description
This project include patients with asymptomatic and symptomatic carotid stenosis >50%. Patients with acute ischemic stroke will also be included with carotid artery stenosis <50% (study 3). The patient group will undergo a clinical neurological examination, ultrasound of the neck-arteries and a blood sample. The majority will also have a CT-angiography of the neck arteries and a cerebral MRI or CT. Carotid plaques removed by surgery (carotid end-arterectomy) and thrombs removed by thrombectomy will undergo histological analyses.
Study 1:
Plasma markers will be analysed and compared to clinical symptoms, ultrasound assessment of the plaque, cerebral MRI (or CT).
Study 2:
Results from advanced ultrasound of the carotid plaque including assessment of plaque morphology will be compared to histology of the removed plaque. Plasma markers and clinic will be related to the findings. The correlation between the different diagnostic modalities and the histologic conclusion will be assessed.
Study 3:
This study focus on plasma markers in an acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source. Thrombi removed from the cerebral artery by thrombectomy will undergo histological analysis and the results will be compared to plasma markers and stroke aetiology.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Year
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with carotid atherosclerosis and/ or cerebrovascular symptoms/ disease.
Key inclusion criteria (2 listed)
- All patients with an atherosclerotic carotid stenosis >50% admitting one of the study centres as an in-patient or an out-patient will be considered for inclusion.
- Acute stroke patients treated with thrombectomy at Oslo University Hospital will be included even though the carotid stenosis is < 50%.
Key exclusion criteria (2 listed)
- Malign disease
- Inflammatory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Plasma markers and advanced ultrasound of neck arteries to detect plaque instability, predict stroke risk and correlation to stroke aetiology.
Time frame: one year
Blood test, ultrasound, cerebral MRI, clinical assessment
3 secondary outcomes
Plasma markers to predict plaque instability
Time frame: At inclusion
Advanced ultrasound for detection of carotid plaque instability
Time frame: At inclusion and after one year
Plasma markers to determine correlation of acute ischemic stroke due to a carotid plaque compared to an acute ischemic stroke with a cardial embolic source
Time frame: At inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2022.
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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.
Mona Skjelland, MD/postdoc principal investigator
Oslo University Hospital
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 Atherosclerosis and Inflammation, run by Oslo University Hospital at 1 site in Norway.
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 2 inclusion and 2 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: under way, not looking for participants, as of the sponsor's last update on 25 Apr 2022. 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 Norway. 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?
This study is still under way. Results are not available in the source record yet.
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?
Plasma markers and advanced ultrasound of neck arteries to detect plaque instability, predict stroke risk and correlation to stroke aetiology. (time frame: one year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Apr 2022.