AtherosclerosisNCT02436967
Classification of Carotid Plaque With Computed Tomography With Fast kVp (Kilovolt Peak)-Switching Technique
An observational study of Atherosclerosis and Carotid Stenosis, run by Karolinska Institutet at 1 site in Sweden.
Trial summary
Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Atherosclerosis, Carotid Stenosis
- What is being tested?
- Carotid endarterectomy in clinical healthcare.
- How many people
- 31 participants
- Where
- 1 siteSweden
- Study dates
- Dec 2014to Mar 2021
- 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 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients that are scheduled for CEA (carotid endarterectomy) and volunteer to participate in this study (fulfilling the incl and excl criteria).
Who may be able to join
- 50% stenosis (NASCET) or more based on CTA (CT-angiography),
- MRI or US,
- Scheduled for CEA
- 50 years or older,
- Normal kidney function (estimated GFR (glomerular filtration rate) 60 ml/min or more).
Who cannot join
- Contraindications to iodine contrast media,
- Contraindications to MRI or gadolinium contrast media.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Karolinska Institutet, Karolinska University Hospital
Stockholm, 17176
About this study
Official title: Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI
Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique.
To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.
Read the detailed description
Patients planned for CEA (carotid endarterectomy) due to carotid stenosis will be examined with one extra CT and MRI before surgery. The CEA specimen is stored in the BiKE-registry (a biobank of operated carotid plaque at the Karolinska Institute). In that registry the patients will be given a personal code which is used to identify the CT, MRI and histology data further on.
Approved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.
- Conditions
- Atherosclerosis, Carotid Stenosis
- Being tested
- Carotid endarterectomy in clinical healthcare.
- Medical subject headings
- Atherosclerosis, Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid endarterectomy in clinical healthcare.Other
For the this study itself there is no intervention caused by the extra CT or MRI. The patients are scheduled for surgery as the routine intervention to reduce the risk of a new stroke in clinical practice. The performed extra diagnostic CT and MRI in this study before surgery will compare the vessel wall images with histology regardless of the patients status or medication.
What is being measured
The primary outcome is the main question the study is designed to answer.
Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology
The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks
Measured: 4 weeks
Secondary outcomes (1)
Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI
The time between fast kVp-switching CT and MRI examinations and reporting is usually approximately 1week.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2015 (estimated)
- Study startDec 2014
- Primary completionMar 2021
- Study completionMar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for AtherosclerosisStudies 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
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Staffan Holmin, Karolinska Institutet
- Investigators
- Staffan Holmin, Professor, Principal investigator, Dept of Clinical Neuroscience, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02436967
- Sponsor's protocol ID
- SN 020 DECTA
- Status last verified
- Oct 2023
- First submitted
- 29 Mar 2015
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Stary HC, Chandler AB, Dinsmore RE, Fuster V, Glagov S, Insull W Jr, Rosenfeld ME, Schwartz CJ, Wagner WD, Wissler RW. A definition of advanced types of atherosclerotic lesions and a histological classification of atherosclerosis. A report from the Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation. 1995 Sep 1;92(5):1355-74. doi: 10.1161/01.cir.92.5.1355.
PubMed 7648691Cai JM, Hatsukami TS, Ferguson MS, Small R, Polissar NL, Yuan C. Classification of human carotid atherosclerotic lesions with in vivo multicontrast magnetic resonance imaging. Circulation. 2002 Sep 10;106(11):1368-73. doi: 10.1161/01.cir.0000028591.44554.f9.
PubMed 12221054
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Classification of Carotid Plaque With Computed Tomography With Fast kVp-switching Technique: A Comparison With Histology and 3-Tesla MRI
- ClinicalTrials.gov ID
- NCT02436967
- Acronym / sponsor ID
- SN 020 DECTA
- Conditions
- Atherosclerosis, Carotid Stenosis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- Dec 2014
- Primary completion
- Mar 2021 (actual)
- Study completion
- Mar 2021 (actual)
- First posted
- 7 May 2015 (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.
Classification of carotid plaque vessel wall changes in carotid stenosis accordingly to AHA classification (American Heart Association)- comparison between histology and CT. The CT is performed with a fast kVp-switching dual energy technique.
To compare the ability to detect iodine contrast enhancement in the carotid plaque compared with 3T MRI with gadolinium.
Detailed description
Patients planned for CEA (carotid endarterectomy) due to carotid stenosis will be examined with one extra CT and MRI before surgery. The CEA specimen is stored in the BiKE-registry (a biobank of operated carotid plaque at the Karolinska Institute). In that registry the patients will be given a personal code which is used to identify the CT, MRI and histology data further on.
Approved by regional ethical review board in Stockholm and local radiation comity at Karolinska University Hospital Solna (Dnr K2435-2014). Informed consent from the participating patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients that are scheduled for CEA (carotid endarterectomy) and volunteer to participate in this study (fulfilling the incl and excl criteria).
Key inclusion criteria (5 listed)
- 50% stenosis (NASCET) or more based on CTA (CT-angiography),
- MRI or US,
- Scheduled for CEA
- 50 years or older,
- Normal kidney function (estimated GFR (glomerular filtration rate) 60 ml/min or more).
Key exclusion criteria (2 listed)
- Contraindications to iodine contrast media,
- Contraindications to MRI or gadolinium contrast media.
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 |
|---|---|---|
| Carotid endarterectomy in clinical healthcare.For the this study itself there is no intervention caused by the extra CT or MRI. The patients are scheduled for surgery as the routine intervention to reduce the risk of a new stroke in clinical practice. The performed extra diagnostic CT and MRI in this study before surgery will compare the vessel wall images with histology regardless of the patients status or medication. | Other | – |
Primary outcome
Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology
Time frame: 4 weeks
The time between radiological examination, surgery and histological analysis is usually approximately 4 weeks
1 secondary outcome
Comparison between the ability to detect contrast enhancement in the carotid plaque: Fast kVp-switching CT vs 3T MRI
Time frame: 1 week
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 23 Oct 2023.
- Results publication: PubMed 7648691Stary HC, Chandler AB, Dinsmore RE, Fuster V, Glagov S, Insull W Jr, Rosenfeld ME, Schwartz CJ, Wagner WD, Wissler RW. A definition of advanced types of atherosclerotic lesions and a histological classification of atherosclerosis. A report from the Committee on Vascular Lesions of the Council on Arteriosclerosis, American Heart Association. Circulation. 1995 Sep 1;92(5):1355-74. doi: 10.1161/01.cir.92.5.1355.
- Results publication: PubMed 12221054Cai JM, Hatsukami TS, Ferguson MS, Small R, Polissar NL, Yuan C. Classification of human carotid atherosclerotic lesions with in vivo multicontrast magnetic resonance imaging. Circulation. 2002 Sep 10;106(11):1368-73. doi: 10.1161/01.cir.0000028591.44554.f9.
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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.
Staffan Holmin, Professor principal investigator
Dept of Clinical Neuroscience, 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 Atherosclerosis and Carotid Stenosis, 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 5 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: finished, as of the sponsor's last update on 23 Oct 2023. 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?
Classification of the carotid plaque accordingly to AHA classification: Fast kVp-switching dual energy CT with histology (time frame: 4 weeks). 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 NCT02436967, which also lists 2 linked publications.
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 23 Oct 2023.