Cardiovascular RiskPERCEPTIONNCT01781416
Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk
An observational study of Cardiovascular Risk, run by AstraZeneca at 1 site in France.
Trial summary
This is a national, non interventional, prospective study performed in the general practice setting. The study has been designed : to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians, and to evaluate the impact of patients'… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiovascular Risk
- How many people
- 799 participants
- Where
- 1 siteFrance
- Study dates
- Nov 2013to Apr 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All adults aged 50 and over who : * are currently in primary prevention for a cardiovascular event, * are usually treated by the general practitioner, * and have a medical visit during the study period.
Who may be able to join
- Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event)
- Usually treated by the GP
- Having signed the information and consent form
Who cannot join
- Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)
- Patient unable to read and complete the study documentation
Trial locations and contacts
1 site in 1 country.
About this study
This is a national, non interventional, prospective study performed in the general practice setting.
The study has been designed :
- to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,
- and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.
Read the detailed description
LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK
- Conditions
- Cardiovascular Risk
- Keywords
- cardiovascular risk, SCORE, cardiovascular primary prevention, risk factors
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 |
|---|---|---|
| 1 | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet)
Measured: Baseline
Cardiovascular risk assessed by physicians
Measured: Baseline
Secondary outcomes (5)
Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet
Measured: Baseline
Actual cardiovascular risk calculated using SCORE
Measured: Baseline
Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR
Measured: Baseline
Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR
Measured: Baseline
Risk factors considered by patients in self-assessing their CVR
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2013 (estimated)
- Study startNov 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular RiskStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 799 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Atul PATHAK, Professor, Study chair, Service de Pharmacologie Clinique - Unite INSERM U 1048 - Faculte de Medecine - 37 Allees Jules Guesde -31073 Toulouse- FRANCENicolas DANCHIN, Professor, Study chair, Unite des Maladies Coronaires - Hopital Europeen Georges Pompidou - 20 Rue Leblanc - 75015 Paris - FRANCE
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01781416
- Sponsor's protocol ID
- NIS-CFR-XXX-2012/1
- Acronym
- PERCEPTION
- Status last verified
- May 2014
- First submitted
- 30 Jan 2013
- Last updated
- 20 May 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk
- ClinicalTrials.gov ID
- NCT01781416
- Acronym / sponsor ID
- PERCEPTION / NIS-CFR-XXX-2012/1
- Conditions
- Cardiovascular Risk
- Keywords
- cardiovascular risk, SCORE, cardiovascular primary prevention, risk factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 799 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 1 Feb 2013 (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.
This is a national, non interventional, prospective study performed in the general practice setting.
The study has been designed :
- to assess the level of concordance between patients' cardiovascular risk perception and the cardiovascular risk evaluated by the physicians,
- and to evaluate the impact of patients' exposure to a medical information leaflet on patients' cardiovascular risk perception.
Detailed description
LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | – | – |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All adults aged 50 and over who : * are currently in primary prevention for a cardiovascular event, * are usually treated by the general practitioner, * and have a medical visit during the study period.
Key inclusion criteria (3 listed)
- Currently in primary prevention for a cardiovascular event (patient with no known history of acute cardiovascular or cerebrovascular event)
- Usually treated by the GP
- Having signed the information and consent form
Key exclusion criteria (2 listed)
- Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)
- Patient unable to read and complete the study documentation
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
Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet)
Time frame: Baseline
Cardiovascular risk assessed by physicians
Time frame: Baseline
5 secondary outcomes
Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet
Time frame: Baseline
Actual cardiovascular risk calculated using SCORE
Time frame: Baseline
Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR
Time frame: Baseline
Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR
Time frame: Baseline
Risk factors considered by patients in self-assessing their CVR
Time frame: Baseline
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 20 May 2014.
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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.
Atul PATHAK, Professor study chair
Service de Pharmacologie Clinique - Unite INSERM U 1048 - Faculte de Medecine - 37 Allees Jules Guesde -31073 Toulouse- FRANCE
Nicolas DANCHIN, Professor study chair
Unite des Maladies Coronaires - Hopital Europeen Georges Pompidou - 20 Rue Leblanc - 75015 Paris - FRANCE
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 Cardiovascular Risk, run by AstraZeneca at 1 site 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 3 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: finished, as of the sponsor's last update on 20 May 2014. 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 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.
What does the primary outcome measure?
Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet) (time frame: Baseline). The study lists 2 primary outcomes in all. 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 20 May 2014.