Carotid StenosesANSYSCAPNCT00514592
Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study (ANSYSCAP)
An observational study of Carotid Stenoses, run by Umeå University at 1 site in Sweden.
Trial summary
A single center observational study. Observing the time between cerebrovascular symptoms and Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study months aimed at reducing the delay and increasing the patient safety. 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?
- New Guidelines
- How many people
- 230 participants
- Where
- 1 siteSweden
- Study dates
- Aug 2007to Mar 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
Study population: All patients with a carotid stenosis >50%, preliminary eligable for CEA in the northern region of Sweden
Who may be able to join
- Carotid stenosis >50% according to NASCET criteria
Who cannot join
- Not preliminary judged as having an indication for surgery, before an extensive investigation is launched. Thus, some patients that will not undergo CEA will be included.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study
A single center observational study. Observing the time between cerebrovascular symptoms and Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study months aimed at reducing the delay and increasing the patient safety. Main outcome is to measure the reduction in recurrent stroke with decreased delay to CEA.
Read the detailed description
All patients with a carotid stenosis >50% according to the NASCET-criteria are included. The study does not affect the health care the patients receive. The time between symptom and surgery is compared to the outcome of the CEA after 45 days, 6 months, 1 year and 5 years. An intervention in the form of new practical local and regional guidelines in January 2009 (#17 of the 29 study months) aimed at reducing the delay and increasing the patient safety.
PRIMARY AIM:
To study the risk of Ipsilateral stroke, any stroke, death, any cerebrovascular event, any cardiovascular event.
Two primary analyses:
- Ipsilateral ischemic stroke within 90 Days of the presenting event. This analysis is aimed at the short term risk of pre-operative stroke. Survival analysis will be used. CEA will be used a censor, thus excluding all peri-operative and postoperative strokes.
- All primary endpoints within 5 years of the presenting event. This analysis is aimed att the long term risk of cardio-vascular morbidity and mortality.
Secondary analyses:
- Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral ischemic stroke.
SECONDARY AIM:
To attempt to validate different risk and score systems already published by other sources. Such as can ABCD2-score be used safely to chose between acute and fast normal screening for carotid stenosis?
- Conditions
- Carotid Stenoses
- Being tested
- New Guidelines
- Keywords
- Carotid stenosis, Carotid endarterectomy
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
New GuidelinesOther
New practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety.
| Study group | Role | What they receive |
|---|---|---|
| All | All patients enter the same group Receives: Other: New Guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ipsilateral Ischemic Stroke Before Carotid Endarterectomy
Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.
Measured: Before CEA
Secondary outcomes (1)
Any Stroke Before Carotid Enderarterectomy
Same as primary endpoint, but includes stroke of all types.
Measured: Before CEA
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 completionMar 2010
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- Observational
- Time perspective
- Prospective
- Enrolment
- 230 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
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00514592
- Sponsor's protocol ID
- EJ-0418
- Acronym
- ANSYSCAP
- Status last verified
- Sep 2013
- First submitted
- 9 Aug 2007
- Last updated
- 23 Oct 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1.
PubMed 15043958
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Additional Neurological Symptoms Before Surgery of the Carotid Arteries - A Prospective Study
- ClinicalTrials.gov ID
- NCT00514592
- Acronym / sponsor ID
- ANSYSCAP / EJ-0418
- Conditions
- Carotid Stenoses
- Keywords
- Carotid stenosis, Carotid endarterectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Umeå UniversityUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 10 Aug 2007 (estimated)
- Results
- Posted 13 Sep 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A single center observational study. Observing the time between cerebrovascular symptoms and Carotid Endarterectomy (CEA) and patient outcome. An intervention at 17 of the 29 study months aimed at reducing the delay and increasing the patient safety. Main outcome is to measure the reduction in recurrent stroke with decreased delay to CEA.
Detailed description
All patients with a carotid stenosis >50% according to the NASCET-criteria are included. The study does not affect the health care the patients receive. The time between symptom and surgery is compared to the outcome of the CEA after 45 days, 6 months, 1 year and 5 years. An intervention in the form of new practical local and regional guidelines in January 2009 (#17 of the 29 study months) aimed at reducing the delay and increasing the patient safety.
PRIMARY AIM:
To study the risk of Ipsilateral stroke, any stroke, death, any cerebrovascular event, any cardiovascular event.
Two primary analyses:
- Ipsilateral ischemic stroke within 90 Days of the presenting event. This analysis is aimed at the short term risk of pre-operative stroke. Survival analysis will be used. CEA will be used a censor, thus excluding all peri-operative and postoperative strokes.
- All primary endpoints within 5 years of the presenting event. This analysis is aimed att the long term risk of cardio-vascular morbidity and mortality.
Secondary analyses:
- Same as first primary analysis, but including all stroke as endpoint, not only ipsilateral ischemic stroke.
SECONDARY AIM:
To attempt to validate different risk and score systems already published by other sources. Such as can ABCD2-score be used safely to chose between acute and fast normal screening for carotid stenosis?
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All | – | Other: New GuidelinesAll patients enter the same group |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with a carotid stenosis >50%, preliminary eligable for CEA in the northern region of Sweden
Key inclusion criteria (1 listed)
- Carotid stenosis >50% according to NASCET criteria
Key exclusion criteria (1 listed)
- Not preliminary judged as having an indication for surgery, before an extensive investigation is launched. Thus, some patients that will not undergo CEA will be included.
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 |
|---|---|---|
| New GuidelinesNew practical guidelines after half of the study aimed at reducing the delay and increasing the patient safety. | Other | All |
Primary outcome
Ipsilateral Ischemic Stroke Before Carotid Endarterectomy
Time frame: Before CEA
Ipsilateral ischemic stroke after the presenting event. Only events that occurs within 90 days and before Carotid EndArterectomy (CEA) is used.
1 secondary outcome
Any Stroke Before Carotid Enderarterectomy
Time frame: Before CEA
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 15043958Rothwell PM, Eliasziw M, Gutnikov SA, Warlow CP, Barnett HJ; Carotid Endarterectomy Trialists Collaboration. Endarterectomy for symptomatic carotid stenosis in relation to clinical subgroups and timing of surgery. Lancet. 2004 Mar 20;363(9413):915-24. doi: 10.1016/S0140-6736(04)15785-1.
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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
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 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 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 23 Oct 2013. 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?
Yes. Results are posted in the registry (first posted 13 Sep 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Ipsilateral Ischemic Stroke Before Carotid Endarterectomy (time frame: Before CEA). 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 NCT00514592, 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 23 Oct 2013.