Carotid StenosesSPACENCT00514644
Stroke and Panorama - Analyzing Carotid Endocalcifications (SPACE)
A study testing Carotid ultrasound examination and Panorama examination in people with Carotid Stenoses, run by Umeå University at 1 site in Sweden.
Trial summary
The odontological radiology method Panorama is known to be able to spot calcifications in the area of the carotid arteries. The calcifications could be carotid stenoses which is affiliated with an increased risk of stroke. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Carotid Stenoses
- What is being tested?
- Carotid ultrasound examination and Panorama examination
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 266 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2007to Feb 2010
- Phase
- Interventional
- 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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Panorama to Ultrasound arm:
- Calcifications in the area of the carotid arteries seen och panorama
- Ultrasound to Panorama arm:
- Known carotid stenosis > 50%
- Must undergo carotid endoarterectomy after the panoramic examination
Who cannot join
- Panorama to Ultrasound arm:
- Previous cerebrovascular symptoms
- Below 18 or above 75 years of age
- Ultrasound to Panorama arm:
- Below 18 or above 90 years of age
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Stroke and Panorama - Analyzing Carotid Endocalcifications
The odontological radiology method Panorama is known to be able to spot calcifications in the area of the carotid arteries. The calcifications could be carotid stenoses which is affiliated with an increased risk of stroke. The study aims to investigate if panorama examinations can be used as a starting point for further investigation of the carotid arteries.
Read the detailed description
We intend to examinate 100 consecutive persons that have calcifications in the area of the carotid arteries with carotid duplex-ultrasound. The prevalence of carotid stenoses > 50% (According to the NASCET criteria) in this group is the primary result of interest, answering the most fundamental question - should persons with calcifications in the area of the carotid arteries seen on panorama be screened with ultrasound in order to find asymptomatic carotid stenoses? Since the publication of the ACST and the ACAS studies it is clear that some of these patients might have indications for surgery.
A second part of the study aims to more fully understand what it is that the panorama examination reveals. In this part will 100 patients that are going to undergo surgery to remove their carotid stenoses will be examined with panorama. The carotid plaque that is removed during the surgery will be examined radiologically.
Primary endpoint:
- Subpopulation prevalence of carotid stenoses > 50% in persons with calcifications in the area of the carotid arteries seen in a panoramic examination.
Secondary endpoints:
- Statistical data (sensitivity, specificity, accuracy, likelihood ratio and predictive values) for panorama to find carotid stenoses with ultrasound as gold standard.
- Qualitative description of the relationship between panoramic calcification images and the removed carotid plaques.
AMENDMENT JUNE 2011: The different arms of the study will be published seperately.
- Conditions
- Carotid Stenoses
- Being tested
- Carotid ultrasound examination, Panorama examination
- Keywords
- Panorama, Carotid stenoses
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carotid ultrasound examinationOther
Ultrasonographic examination of the carotid arteries to determine the grade of carotid stenosis.
Panorama examinationOther
Examination with the odontological radiological method "Panorama", including a frontal verification image
| Study group | Role | What they receive |
|---|---|---|
| Panorama to Ultrasound | Experimental | 100 asymptotic patients that have findings of calcifications in the area of the carotid arteries when examined with panorama. These persons are examined with carotid ultrasound. Receives: Other: Carotid ultrasound examination |
| Ultrasound to Panorama | Experimental | 100 patients with a known carotid stenosis seen on ultrasound will be examined with panorama before any intervention is made. These patients must undergo surgery to be finally included. Receives: Other: Panorama examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2007 (estimated)
- Study startAug 2007
- Primary completionNov 2009
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Carotid StenosesStudies of the same condition, open and under way.
- More trials run by Umeå UniversityThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 266 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umeå University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elias Johansson, Umeå University
- Investigators
- Per G Wester, Prof., Principal investigator, Umea UniversityJan Ahlqvist, Docent, Principal investigator, Umea UniversityEva Levring Jäghagen, Lector, Principal investigator, Umea UniversityElias P Johansson, PhD Student, Principal investigator, Umea University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514644
- Sponsor's protocol ID
- EJ-8404
- Acronym
- SPACE
- Status last verified
- Jan 2012
- First submitted
- 9 Aug 2007
- Last updated
- 10 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Publications
Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923.
PubMed 10796451Yin D, Carpenter JP. Cost-effectiveness of screening for asymptomatic carotid stenosis. J Vasc Surg. 1998 Feb;27(2):245-55. doi: 10.1016/s0741-5214(98)70355-6.
PubMed 9510279Almog DM, Horev T, Illig KA, Green RM, Carter LC. Correlating carotid artery stenosis detected by panoramic radiography with clinically relevant carotid artery stenosis determined by duplex ultrasound. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Dec;94(6):768-73. doi: 10.1067/moe.2002.128965.
PubMed 12464905Friedlander AH, Garrett NR, Chin EE, Baker JD. Ultrasonographic confirmation of carotid artery atheromas diagnosed via panoramic radiography. J Am Dent Assoc. 2005 May;136(5):635-40; quiz 682-3. doi: 10.14219/jada.archive.2005.0235.
PubMed 15966651Johansson EP, Ahlqvist J, Garoff M, Karp K, Jaghagen EL, Wester P. Ultrasound screening for asymptomatic carotid stenosis in subjects with calcifications in the area of the carotid arteries on panoramic radiographs: a cross-sectional study. BMC Cardiovasc Disord. 2011 Jul 13;11:44. doi: 10.1186/1471-2261-11-44.
PubMed 21752238
Study at a glance
From the registry record, last updated by the sponsor on 10 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stroke and Panorama - Analyzing Carotid Endocalcifications
- ClinicalTrials.gov ID
- NCT00514644
- Acronym / sponsor ID
- SPACE / EJ-8404
- Conditions
- Carotid Stenoses
- Keywords
- Panorama, Carotid stenoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 266 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Nov 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 10 Aug 2007 (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 odontological radiology method Panorama is known to be able to spot calcifications in the area of the carotid arteries. The calcifications could be carotid stenoses which is affiliated with an increased risk of stroke. The study aims to investigate if panorama examinations can be used as a starting point for further investigation of the carotid arteries.
Detailed description
We intend to examinate 100 consecutive persons that have calcifications in the area of the carotid arteries with carotid duplex-ultrasound. The prevalence of carotid stenoses > 50% (According to the NASCET criteria) in this group is the primary result of interest, answering the most fundamental question - should persons with calcifications in the area of the carotid arteries seen on panorama be screened with ultrasound in order to find asymptomatic carotid stenoses? Since the publication of the ACST and the ACAS studies it is clear that some of these patients might have indications for surgery.
A second part of the study aims to more fully understand what it is that the panorama examination reveals. In this part will 100 patients that are going to undergo surgery to remove their carotid stenoses will be examined with panorama. The carotid plaque that is removed during the surgery will be examined radiologically.
Primary endpoint:
- Subpopulation prevalence of carotid stenoses > 50% in persons with calcifications in the area of the carotid arteries seen in a panoramic examination.
Secondary endpoints:
- Statistical data (sensitivity, specificity, accuracy, likelihood ratio and predictive values) for panorama to find carotid stenoses with ultrasound as gold standard.
- Qualitative description of the relationship between panoramic calcification images and the removed carotid plaques.
AMENDMENT JUNE 2011: The different arms of the study will be published seperately.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Panorama to Ultrasound | Experimental | Other: Carotid ultrasound examination100 asymptotic patients that have findings of calcifications in the area of the carotid arteries when examined with panorama. These persons are examined with carotid ultrasound. |
| Ultrasound to Panorama | Experimental | Other: Panorama examination100 patients with a known carotid stenosis seen on ultrasound will be examined with panorama before any intervention is made. These patients must undergo surgery to be finally included. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Panorama to Ultrasound arm:
- Ultrasound to Panorama arm:
Key exclusion criteria (5 listed)
- Panorama to Ultrasound arm:
- Ultrasound to Panorama arm:
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 ultrasound examinationUltrasonographic examination of the carotid arteries to determine the grade of carotid stenosis. | Other | Panorama to Ultrasound |
| Panorama examinationExamination with the odontological radiological method "Panorama", including a frontal verification image | Other | Ultrasound to Panorama |
Primary outcome
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication
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 10 Jan 2012.
- Background: PubMed 10796451Chambers BR, You RX, Donnan GA. Carotid endarterectomy for asymptomatic carotid stenosis. Cochrane Database Syst Rev. 2000;(2):CD001923. doi: 10.1002/14651858.CD001923.
- Background: PubMed 9510279Yin D, Carpenter JP. Cost-effectiveness of screening for asymptomatic carotid stenosis. J Vasc Surg. 1998 Feb;27(2):245-55. doi: 10.1016/s0741-5214(98)70355-6.
- Background: PubMed 12464905Almog DM, Horev T, Illig KA, Green RM, Carter LC. Correlating carotid artery stenosis detected by panoramic radiography with clinically relevant carotid artery stenosis determined by duplex ultrasound. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2002 Dec;94(6):768-73. doi: 10.1067/moe.2002.128965.
- Background: PubMed 15966651Friedlander AH, Garrett NR, Chin EE, Baker JD. Ultrasonographic confirmation of carotid artery atheromas diagnosed via panoramic radiography. J Am Dent Assoc. 2005 May;136(5):635-40; quiz 682-3. doi: 10.14219/jada.archive.2005.0235.
- Results publication: PubMed 21752238Johansson EP, Ahlqvist J, Garoff M, Karp K, Jaghagen EL, Wester P. Ultrasound screening for asymptomatic carotid stenosis in subjects with calcifications in the area of the carotid arteries on panoramic radiographs: a cross-sectional study. BMC Cardiovasc Disord. 2011 Jul 13;11:44. doi: 10.1186/1471-2261-11-44.
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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.
Per G Wester, Prof. principal investigator
Umea University
Jan Ahlqvist, Docent principal investigator
Umea University
Eva Levring Jäghagen, Lector principal investigator
Umea University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carotid ultrasound examination and Panorama examination in people with Carotid Stenoses, run by Umeå University 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 5 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 10 Jan 2012. 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?
The prevalence of carotid stenosis in the group that is examined with carotid ultrasound on the "atheroma on Panoramic examination"-indication. 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 NCT00514644, which also lists 5 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 10 Jan 2012.