Carotid Artery StenosisNCT01458860
Aortic Calcification - is it a Marker for Carotid Artery Stenosis?
An observational study of Carotid Artery Stenosis and Aortic Calcification, run by Ziv Hospital.
Trial summary
Atherosclerosis is the major contributor for the morbidity and mortality for the variety of cardiovascular diseases. Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent prognostic factor for the morbidity and mortality from a cardiovascular event. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Carotid Artery Stenosis, Aortic Calcification
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Feb 2012to Feb 2014
- 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 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Group A - patients who had a CT scan Group B - patients who have severe carotid artery stenosis
Who may be able to join
- Group A - patients, age 40-99 years, that had a CT scan for any indication Group B - patients with severe carotid artery stenosis, that indicated for treatment
Who cannot join
- Group A - age <40 years
- Group B - carotid artery stenosis, without intention-to-treat
About this study
Atherosclerosis is the major contributor for the morbidity and mortality for the variety of cardiovascular diseases.
Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent prognostic factor for the morbidity and mortality from a cardiovascular event.
Read more
Carotid artery stenoses is the current accepted indication for interventional treatment of carotid artery, for the prevention of embolic event, while other arterial atherosclerosis indication, is for hemodynamic disturbance and ischemic outcome.
This research will try to find whether incidental aortic calcification can predict carotid artery stenosis.
Two groups will be chosen: group A - patients who had CT scan in the hospital (for different indications); Group B - patients (not from the first group) who have a significant carotid artery stenosis who are indicated for interventional treatment.
The data to analyze:
Group A - Patients with aortic calcification, carotid artery stenosis, and patients with both Group B - Patients who have aortic calcification Comparison of the populations within the group and among the two will show if a significant correlation between aortic calcification and carotid artery stenosis exist.
Read the detailed description
Background - thoracic or abdominal aortic calcification is a documented independent risk factor for cardiovascular atherosclerotic disease and increased death.
Atherosclerosis is a diffuse multicentric disease in the arterial tree, affecting target organs (heart, aorta, lower extremities, carotid arteries etc.). Mostly located in arterial bifurcations (Iliac and carotid artery bifurcations) or in constant repetitive arterial trauma (Adductors tendon, Hunter's canal). The invasive treatment (endovascular, surgery) is preserved for patients with critical arterial stenosis or occlusion in symptomatic patients. Exceptions are the carotid arteries: the majority of patients with a severe internal carotid artery stenosis are asymptomatic patients, which are treated for the prevention embolic events (TIA's or CVA's).
Current articles are observational, and describe retrospectively the morbidity and mortality from atherosclerosis with aortic calcification.
the investigators assumption is that if aortic calcification is a marker for diffuse atherosclerosis, it has good correlation to criptogenous carotid artery disease, and can lead to early carotid artery disease evaluation and treatment.
Purpose - to find a reliable correlation between aortic calcification, and carotid artery stenosis (from atherosclerosis)
Method - two groups will be evaluated:
Group A - patients (age >40 years), that had a CT scan (chest/abdomen) for any indication, will be evaluated for aortic calcifications. The patients will be additionally examined for carotid artery stenosis by Doppler ultrasound. (100 patients) Group B - Patients that were diagnosed by Doppler ultrasound, and were found to have a severe carotid artery stenosis. These patients are scheduled for a computed tomography-angiography (regardless for the research) of the cervical arteries, will be additionally complete abdominal/chest tomography scan, without additional contrast. (50 patients).
Results - will be statistically evaluated - Group A - number of patients with aortic calcification, number of patients with carotid artery stenosis; Group B - Number of patients that have associated aortic calcification.
- Conditions
- Carotid Artery Stenosis, Aortic Calcification
- Medical subject headings
- Carotid Stenosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GROUP A | patients had a CT | |
| GROUP B | patients with severe carotid artery stenosis |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startFeb 2012
- Primary completionFeb 2012 (estimated)
- Study completionFeb 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carotid Artery StenosisStudies of the same condition, open and under way.
- 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 crossover
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ziv Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Tal Salamon, MD, Principal investigator, Zim medical centerAlexander Altsuler, MD, Study director, Ziv Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458860
- Sponsor's protocol ID
- ZIV-11-0041
- Status last verified
- Oct 2011
- First submitted
- 24 Oct 2011
- Last updated
- 1 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Calcification - is it a Marker for Carotid Artery Stenosis?
- ClinicalTrials.gov ID
- NCT01458860
- Acronym / sponsor ID
- ZIV-11-0041
- Conditions
- Carotid Artery Stenosis, Aortic Calcification
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Ziv HospitalOther government
- Study start
- Feb 2012
- Primary completion
- Feb 2012 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 25 Oct 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.
Atherosclerosis is the major contributor for the morbidity and mortality for the variety of cardiovascular diseases.
Aortic calcification on x-ray is a marker for arterial atherosclerosis and an independent prognostic factor for the morbidity and mortality from a cardiovascular event.
Carotid artery stenoses is the current accepted indication for interventional treatment of carotid artery, for the prevention of embolic event, while other arterial atherosclerosis indication, is for hemodynamic disturbance and ischemic outcome.
This research will try to find whether incidental aortic calcification can predict carotid artery stenosis.
Two groups will be chosen: group A - patients who had CT scan in the hospital (for different indications); Group B - patients (not from the first group) who have a significant carotid artery stenosis who are indicated for interventional treatment.
The data to analyze:
Group A - Patients with aortic calcification, carotid artery stenosis, and patients with both Group B - Patients who have aortic calcification Comparison of the populations within the group and among the two will show if a significant correlation between aortic calcification and carotid artery stenosis exist.
Detailed description
Background - thoracic or abdominal aortic calcification is a documented independent risk factor for cardiovascular atherosclerotic disease and increased death.
Atherosclerosis is a diffuse multicentric disease in the arterial tree, affecting target organs (heart, aorta, lower extremities, carotid arteries etc.). Mostly located in arterial bifurcations (Iliac and carotid artery bifurcations) or in constant repetitive arterial trauma (Adductors tendon, Hunter's canal). The invasive treatment (endovascular, surgery) is preserved for patients with critical arterial stenosis or occlusion in symptomatic patients. Exceptions are the carotid arteries: the majority of patients with a severe internal carotid artery stenosis are asymptomatic patients, which are treated for the prevention embolic events (TIA's or CVA's).
Current articles are observational, and describe retrospectively the morbidity and mortality from atherosclerosis with aortic calcification.
the investigators assumption is that if aortic calcification is a marker for diffuse atherosclerosis, it has good correlation to criptogenous carotid artery disease, and can lead to early carotid artery disease evaluation and treatment.
Purpose - to find a reliable correlation between aortic calcification, and carotid artery stenosis (from atherosclerosis)
Method - two groups will be evaluated:
Group A - patients (age >40 years), that had a CT scan (chest/abdomen) for any indication, will be evaluated for aortic calcifications. The patients will be additionally examined for carotid artery stenosis by Doppler ultrasound. (100 patients) Group B - Patients that were diagnosed by Doppler ultrasound, and were found to have a severe carotid artery stenosis. These patients are scheduled for a computed tomography-angiography (regardless for the research) of the cervical arteries, will be additionally complete abdominal/chest tomography scan, without additional contrast. (50 patients).
Results - will be statistically evaluated - Group A - number of patients with aortic calcification, number of patients with carotid artery stenosis; Group B - Number of patients that have associated aortic calcification.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GROUP A | – | –patients had a CT |
| GROUP B | – | –patients with severe carotid artery stenosis |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Group A - patients who had a CT scan Group B - patients who have severe carotid artery stenosis
Key inclusion criteria (1 listed)
- Group A - patients, age 40-99 years, that had a CT scan for any indication Group B - patients with severe carotid artery stenosis, that indicated for treatment
Key exclusion criteria (2 listed)
- Group A - age <40 years
- Group B - carotid artery stenosis, without intention-to-treat
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
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2011.
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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.
Tal Salamon, MD principal investigator
Zim medical center
Alexander Altsuler, MD study director
Ziv Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Carotid Artery Stenosis and Aortic Calcification, run by Ziv Hospital.
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 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: status not confirmed, as of the sponsor's last update on 1 Nov 2011. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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.
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 1 Nov 2011.