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Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk (PERCEPTION)

This study is not yet open for participant recruitment.
Verified April 2013 by AstraZeneca
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT01781416
First received: January 30, 2013
Last updated: April 17, 2013
Last verified: April 2013
History of Changes
  Purpose

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.

Condition
Cardiovascular Risk

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Level of Concordance Between Patients Perception and Physicians Evaluation of Cardiovascular Risk

Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Cardiovascular risk perceived by patients (before reading the Medical Information Leaflet) [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Cardiovascular risk assessed by physicians [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cardiovascular risks perceived by patients before and after reading the Medical Information Leaflet [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Actual cardiovascular risk calculated using SCORE [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Characteristics of patients whose self-evaluation of their CVR is concordant with their actual CVR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Characteristics of patients whose self-evaluation of their CVR is discordant with their actual CVR [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Risk factors considered by patients in self-assessing their CVR [ Time Frame: Baseline ] [ Designated as safety issue: No ]

Estimated Enrollment: 800
Study Start Date: May 2013
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

Detailed Description:

LEVEL OF CONCORDANCE BETWEEN PATIENTS PERCEPTION AND PHYSICIANS EVALUATION OF CARDIOVASCULAR RISK

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Patient with a pathologic vascular ultrasound exam (atheromatous plaque or stenosis)
  • Patient unable to read and complete the study documentation
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01781416

Contacts
Contact: AstraZeneca Clinical Study Information +33.1.41.29.40.00 sandrine.geha@astrazeneca.com

Sponsors and Collaborators
AstraZeneca
Investigators
Study Chair: Atul PATHAK, Professor Service de Pharmacologie Clinique - Unite INSERM U 1048 - Faculte de Medecine - 37 Allees Jules Guesde -31073 Toulouse- FRANCE
Study Chair: Nicolas DANCHIN, Professor Unite des Maladies Coronaires - Hopital Europeen Georges Pompidou - 20 Rue Leblanc - 75015 Paris - FRANCE
  More Information

No publications provided

Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT01781416     History of Changes
Other Study ID Numbers: NIS-CFR-XXX-2012/1
Study First Received: January 30, 2013
Last Updated: April 17, 2013
Health Authority: France: National Consultative Committee on Treatment information for Health and Life Sciences : CCTIRS (Comite Consultatif sur le Traitement de l'Information en matiere de Recherche dans le domaine de la Sante)
France: National Data Privacy Authority : CNIL (Commission Nationale de l'Informatique et des Libertes)
France: National Doctors Governing Body : CNOM (Conseil National de l'Ordre des Medecins)

Keywords provided by AstraZeneca:
cardiovascular risk
SCORE
cardiovascular primary prevention
risk factors

ClinicalTrials.gov processed this record on May 22, 2013