Cardiovascular DiseasesNCT00496717
Aorta Calcium Scoring
An observational study of Cardiovascular Diseases, run by University Hospital, Strasbourg, France at 2 sites in France.
Trial summary
Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular… Read more about this study
- Who is it for?
- Ages 45 years and older
- Conditions the study is for
- Cardiovascular Diseases
- What is being tested?
- Helicoidal fast scann
- Type of treatment
- Injection or infusion, Medical device
- How many people
- 60 participants
- Where
- 2 sitesFrance
- Study dates
- Jul 2007to Dec 2008
- 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 45 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with at least one cardiovascular risk factor in primary prevention. Mainly out patients followed in our cardiology clinic
Who may be able to join
- Patients with at least one cardiovascular risk factor
- Ambulatory or hospitalized patients
Who cannot join
- Significant cardiovascular complications
Trial locations and contacts
2 sites in 1 country.
France2 sites
Service d'Hypertension, Maladies Vasculaires et Pharmacologie Clinique, Nouvel Hôpital Civil, Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
Service de Radiologie, Hôpital Civil
Strasbourg, 67091
About this study
Official title: Measurement of an Abdominal Aorta Calcium Scoring and Its Correlation With Cardiovascular Risk Factors
Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.
- Conditions
- Cardiovascular Diseases
- Being tested
- Helicoidal fast scann
- Keywords
- Calcium scoring/aorta/ cardiovascular risk factor/scann, Patients with at least one cardiovascular risk factor
- Medical subject headings
- Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Helicoidal fast scannDevice
Each patient will have an computed aortic tomodensitometric scan without contrast injection. This procedure lasts few minutes and irradiation is low. The aortic calcium scoring is calculated using a specific program included in the scan machine
| Study group | Role | What they receive |
|---|---|---|
| 1 | There is only one arm and all patients will have their aortic calcium scoring by CT scan. Receives: Device: Helicoidal fast scann |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2008
- Study completionDec 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Investigators
- Dominique STEPHAN, MD, Principal investigator, Hôpitaux Universitaires de Strasbourg
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00496717
- Sponsor's protocol ID
- 3914
- Status last verified
- May 2011
- First submitted
- 3 Jul 2007
- Last updated
- 28 Jul 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Measurement of an Abdominal Aorta Calcium Scoring and Its Correlation With Cardiovascular Risk Factors
- ClinicalTrials.gov ID
- NCT00496717
- Acronym / sponsor ID
- 3914
- Conditions
- Cardiovascular Diseases
- Keywords
- Calcium scoring/aorta/ cardiovascular risk factor/scann, Patients with at least one cardiovascular risk factor
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- Jul 2007
- Primary completion
- Dec 2008 (actual)
- Study completion
- Dec 2008 (actual)
- First posted
- 4 Jul 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.
Calcium scoring of the coronary arteries is use as a predictor of coronary stenosis. The aim of this study is to measure the calcium scoring of the abdominal aorta using an helicoidal fast scan and to correlate this measurement with classical cardiovascular risk factors and newer parameters reflecting vascular rigidity, like pulse velocity measurement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | Device: Helicoidal fast scannThere is only one arm and all patients will have their aortic calcium scoring by CT scan. |
Who may qualify
- Ages
- 45 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with at least one cardiovascular risk factor in primary prevention. Mainly out patients followed in our cardiology clinic
Key inclusion criteria (2 listed)
- Patients with at least one cardiovascular risk factor
- Ambulatory or hospitalized patients
Key exclusion criteria (1 listed)
- Significant cardiovascular complications
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 |
|---|---|---|
| Helicoidal fast scannEach patient will have an computed aortic tomodensitometric scan without contrast injection. This procedure lasts few minutes and irradiation is low. The aortic calcium scoring is calculated using a specific program included in the scan machine | Device | 1 |
Primary outcome
Not reported in the source record.
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 28 Jul 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.
Dominique STEPHAN, MD principal investigator
Hôpitaux Universitaires de Strasbourg
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiovascular Diseases, run by University Hospital, Strasbourg, France at 2 sites in France.
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 2 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 28 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in France. 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.
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 28 Jul 2011.