AtherosclerosisNCT00918541
Natural History of Atherosclerosis
An observational study of Atherosclerosis, run by University of Zurich at 3 sites in Switzerland.
Trial summary
20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Atherosclerosis
- How many people
- 30 participants
- Where
- 3 sitesSwitzerland
- Study dates
- Jan 2007to Mar 2010
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients of the districthospital Bellinzona
Who may be able to join
- stable carotid artery disease not requiring revascularization
- asymptomatic carotid artery stenosis < 80% or symptomatic patients with stenosis < 60 %
- prophylactic therapy with aspirin (> 100mg/day, statin, blood pressure therapy if indicated (goal < 130/80 mmHg))
- informed consent
Who cannot join
- non atherosclerotic occlusive disease (Bürgers disease)
- uncontrolled BP (DBP > 110 mmHg and/or SBP > 200 mmHg)
- hemorrhagic disease or platelet count < 100'000 mm^3
- Known active liver disease (elevations of GPT GOT or increased ammonia)
- impaired renal function (crea > 180 mmol/l)
- pregnancy
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- severe claustrophobic reactions
- short - term life - threatening pathology
- physically unable to participate in the study
- compliance not guaranteed
Trial locations and contacts
3 sites in 1 country.
Switzerland3 sites
Ospedale San Giovanni Bellinzona
Bellinzona
Ospedale San Giovanni
Bellinzona
Cardiovascular Center Cardiology University Hospital Zürich
Zurich
About this study
Official title: Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis
20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease.
- Conditions
- Atherosclerosis
- Keywords
- atherosclerotic disease, progression, natural progression of atherosclerotic disease, natural history of atherosclerosis at the level of the carotid artery as evaluated by MRI
- Medical subject headings
- Atherosclerosis, Disease Progression
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 |
|---|---|---|
| A | asymptomatic patients with mild to moderate carotid artery stenosis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression of atherosclerotic plaque
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2009 (estimated)
- Study startJan 2007
- Primary completionMar 2010
- Study completionMar 2010
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 University of ZurichThe 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
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Collaborators
- Districthospital of Bellinzona
- Responsible party
- Sponsor
- Investigators
- Roberto Corti, MD, Principal investigator, Cardiovascular Center Cardiology, University Hospital Zürich, Zürich SwitzerlandAugusto Gallino, MD, Principal investigator, Ospedale San Giovanni Bellinzona, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00918541
- Sponsor's protocol ID
- CarotidMRI
- Status last verified
- Dec 2011
- First submitted
- 19 Nov 2008
- Last updated
- 23 Dec 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Natural 1-year History of Atherosclerosis in Asymptomatic Patients With Mild to Moderate Carotid Stenosis
- ClinicalTrials.gov ID
- NCT00918541
- Acronym / sponsor ID
- CarotidMRI
- Conditions
- Atherosclerosis
- Keywords
- atherosclerotic disease, progression, natural progression of atherosclerotic disease, natural history of atherosclerosis at the level of the carotid artery as evaluated by MRI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Collaborators
- Districthospital of Bellinzona
- Study start
- Jan 2007
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 11 Jun 2009 (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.
20 patients will be recruited. The aim of the study is to determine the natural progression of atherosclerotic disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A | – | –asymptomatic patients with mild to moderate carotid artery stenosis |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of the districthospital Bellinzona
Key inclusion criteria (4 listed)
- stable carotid artery disease not requiring revascularization
- asymptomatic carotid artery stenosis < 80% or symptomatic patients with stenosis < 60 %
- prophylactic therapy with aspirin (> 100mg/day, statin, blood pressure therapy if indicated (goal < 130/80 mmHg))
- informed consent
Key exclusion criteria (10 listed)
- non atherosclerotic occlusive disease (Bürgers disease)
- uncontrolled BP (DBP > 110 mmHg and/or SBP > 200 mmHg)
- hemorrhagic disease or platelet count < 100'000 mm^3
- Known active liver disease (elevations of GPT GOT or increased ammonia)
- impaired renal function (crea > 180 mmol/l)
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
Progression of atherosclerotic plaque
Time frame: 12 months
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 Dec 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.
Roberto Corti, MD principal investigator
Cardiovascular Center Cardiology, University Hospital Zürich, Zürich Switzerland
Augusto Gallino, MD principal investigator
Ospedale San Giovanni Bellinzona, Switzerland
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Atherosclerosis, run by University of Zurich at 3 sites in Switzerland.
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 4 inclusion and 10 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 Dec 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Switzerland. 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?
Progression of atherosclerotic plaque (time frame: 12 months). 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 23 Dec 2011.