Cardiovascular RiskNCT01039402

Connection Between General Practitioner's (GP's) Estimation of Cardiovascular Risk and Theoretical Calculation in France

An observational study of Cardiovascular Risk, run by AstraZeneca at 275 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation. Read more about this study

Who is it for?: Ages 50 years and olderHealthy volunteers can take part
Conditions the study is for: Cardiovascular Risk
How many people: 13,502 participants
Where: 275 sitesFrance
Study dates: Dec 2009to Jan 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 50 years and older
All sexes
Healthy volunteers accepted
Adult, Older adult

Study population: Primary care

Who may be able to join

Adults 50 years old and over, visiting their GPs

Who cannot join

None listed.

Trial locations and contacts

275 sites in 1 country.

City, postcode or hospital

275 sites in 1 country

France275 sites

Research Site
Ajaccio
Research Site
Ancenis
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Andernos-les-Bains
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Andlau
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Andrézieux-Bouthéon
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Angoulême
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Annecy
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Annezin
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Antibes
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Antony
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Arcey
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Arches
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Argences
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Argenteuil
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Arras
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Aubigny-en-Artois
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Aujargues
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Auriol
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Avignon
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Avoine
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Baixas
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Balma
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Banon
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Baumont Les Valence
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Beaumont-sur-Oise
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Belfort
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Belleville
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Benest
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Bergbinten
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Bergerac
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Bersée
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Besançon
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Bessancourt
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Bétaille
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Bethoncourt
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Bezanes
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Béziers
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Biarritz
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Bléré
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Blois
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Bondues
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Bonnieux
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Bordeaux
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Bosmie
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Boulogne-Billancourt
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Bourbriac
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Bourg-de-Thizy
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Brebières
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Brest
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Brivé
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Brunoy
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Buc
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Bugeat
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Cachan
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Caluire-et-Cuire
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Camblain-lAbbé
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Cannes
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Carpentras
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Carquefou
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Carvin
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Châlons-en-Champagne
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Chamonix
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Champagnole
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Chaumont
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Cherbourg
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Chevannes
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Chinon
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Clermont-Ferrand
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Collioure
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Colombey-les-Belles
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Couëron
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Courbevoie
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Courpière
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Coutiches
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Crach
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Croissy-sur-Seine
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Cugnaux
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Dambach-la-Ville
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Devecey
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Digne-les-Bains
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Dijon
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Dole
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Donville-les-Bains
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Douchy-les-Mines
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Échirolles
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Écully
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Elliant
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Espelette
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Espondeilhan
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Fabrezan
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Fenioux
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Fontenay-sous-Bois
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Fouesnant
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Fougères
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Franconville
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Fréhel
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Fronton
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Gonesse
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Gratentour
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Grenoble
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Guérande
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Hay Les Roses
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Houilles
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Irigny
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Jouy-le-Moutier
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La Courneuve
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La Couronne
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La Londe
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La Motte-Servolex
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La Riche
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Lamagistère
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Lambersart
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Lapugnoy
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Latresne
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Lattes
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Laval
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Le Bourget
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Le Chesnay
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Le Grand-Lemps
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Le Havre
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Le Lude
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Le Port-Marly
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Le Quesnoy
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Le Russey
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Les Pennes-Mirabeau
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Les Pujols
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Les Sables-d'Olonne
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Lherbergement
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Lille
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Limeray
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Limoges
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Longtpont Sur Orge
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Louviers
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Lumbin
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Lyon
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Marcq-en-Barœul
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Mareuil-sur-Lay
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Marignane
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Marles-les-Mines
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Marlesmines
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Marquette Les Lille
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Marseille
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Mauléon-Licharre
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Méounes-lès-Montrieux
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Méréville
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Merville
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Metz
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Monteux
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Montigny-le-Bretonneux
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Montigny-lès-Cormeilles
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Montmain
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Montmorillon
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Montpellier
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Montreuil
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Montrond-le-Château
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Montrouge
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Morcenx
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Moreuil
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Mourenx
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Mouvaux
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Nancy
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Nantes
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Narbonne
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Néré
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Neuilly-Plaisance
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Neuville-en-Ferrain
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Nice
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Nieuil-l'Espoir
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Nîmes
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Norges Le Bas
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Noyon
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Oberhausbergen
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Oignies
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Orléans
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Paris
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Périgueux
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Pérols
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Pessac
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Peyruis
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Pierrefitte-sur-Sauldre
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Plabennec
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Pleubian
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Pocé-sur-Cisse
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Poitiers
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Pompey
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Pont Labbe Darnoult
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Pont-Évêque
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Portet-sur-Garonne
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Pouilley-les-Vignes
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Prey
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Privas
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Provins
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Puyricard
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Reims
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Rennes
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Riedishiem
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Rodilhan
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Romainville
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Rosiers Degletons
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Roubaix
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Rousset
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Royan
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Rueil-Malmaison
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Rugles
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Sainghin-en-Mélantois
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Saint Gervais Dauvergne
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Saint Maurice Les Chatauneuf
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Saint-Aigulin
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Saint-Amant-de-Boixe
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Saint-Apollinaire
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Saint-Avold
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Saint-Brieuc
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Saint-Etienne
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Saint-Étienne-les-Orgues
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Saint-Germain-de-la-Coudre
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Saint-Germain-en-Laye
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Saint-Jean-Pied-de-Port
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Saint-Léger-des-Bois
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Saint-Lô
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Saint-martin Dauxigny
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Saint-Michel
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Saint-Nazaire
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Saint-Paul-en-Jarez
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Saint-Prest
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Saint-Prouant
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Saint-Rémy-de-Provence
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Saint-valier
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Sainte-Foy-de-Peyrolières
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Salomé
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Salouël
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Schiltigheim
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Segonzac
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Sélestat
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Sète
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Simiane-Collongue
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Soissons
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Sonchamp
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Strasbourg
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Suippes
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Théoule-sur-Mer
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Thiviers
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Thorigné-Fouillard
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Thouaré-sur-Loire
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Thun-Saint-Amand
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Tionville
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Toulon
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Toulouse
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Tourcoing
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Tours
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Toussieu
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Uchaud
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Ussel
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Uxem
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Valence Dalbigeois
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Vandœuvre-lès-Nancy
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Vanves
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Vaugneray
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Vennecy
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Verneuil-sur-Avre
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Verson
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Veynes
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Vezins
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Villejuif
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Villeneuve Dascq
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Villeneuve-Loubet
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Villennes-sur-Seine
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Villers-lès-Nancy
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Villeurbanne
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Vincennes
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Visan
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Voiron
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Wasquehal
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Wasselonne
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Witry-lès-Reims
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Wœrth

Other trials in France

About this study

Official title: Connection Between GP's Estimation of Cardiovascular Risk and Theoretical Calculation in France

The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.

Conditions: Cardiovascular Risk
Keywords: cardiovascular risk, France, Observational, descriptive study

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT01039402
Study group	Role	What they receive
1		Adults ≥ 50 years old

What is being measured

The primary outcome is the main question the study is designed to answer.

To evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation (according to guidelines and validated scales (such as risk score profile in the Framingham Heart study or the SCORE risk estimation))
Measured: At the end of the study

Secondary outcomes (3)

To estimate the number of cardiovascular risk patients, that have not been identified
Measured: At the end of the study
To characterize those patients according to their theoretical cardiovascular risk (high, medium, low)
Measured: At the end of the study
to reveal GP's estimation of cardiovascular risk is especially driven by LDL
Measured: At the end of the study

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Dec 2009Jan 2010

First posted25 Dec 2009 (estimated)
Study startDec 2009
Primary completionJan 2010
Study completionJan 2010

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: Cohort
Time perspective: Cross-sectional
Enrolment: 13,502 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01039402
Sponsor's protocol ID: NIS-CFR-DUM-2009/3
Status last verified: Sep 2010
First submitted: 24 Dec 2009
Last updated: 16 Sep 2010
Results posted: No
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Cardiovascular Risk trials

Study at a glance

From the registry record, last updated by the sponsor on 16 Sep 2010. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Connection Between GP's Estimation of Cardiovascular Risk and Theoretical Calculation in France
ClinicalTrials.gov ID: NCT01039402
Acronym / sponsor ID: NIS-CFR-DUM-2009/3
Conditions: Cardiovascular Risk
Keywords: cardiovascular risk, France, Observational, descriptive study
Study type: Observational
Recruitment status: Completed
Enrolment: 13,502 participants (estimated)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Study start: Dec 2009
Primary completion: Jan 2010 (actual)
Study completion: Jan 2010 (actual)
First posted: 25 Dec 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.

The purpose of this study is to evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation.

Study design

Observational model: Cohort
Time perspective: Cross-sectional
Number of arms: 1

Arm	Type	Receives
1	–	–Adults ≥ 50 years old

Who may qualify

Ages: 50 years and older
Sex: All
Healthy volunteers: Accepted
Age groups: Adult, Older adult
Study population: Primary care

Key inclusion criteria (1 listed)

Adults 50 years old and over, visiting their GPs

Key exclusion criteria (0 listed)

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

To evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation (according to guidelines and validated scales (such as risk score profile in the Framingham Heart study or the SCORE risk estimation))
Time frame: At the end of the study

3 secondary outcomes

To estimate the number of cardiovascular risk patients, that have not been identified
Time frame: At the end of the study
To characterize those patients according to their theoretical cardiovascular risk (high, medium, low)
Time frame: At the end of the study
to reveal GP's estimation of cardiovascular risk is especially driven by LDL
Time frame: At the end of the study

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 16 Sep 2010.

Related trials for Cardiovascular Risk

RecruitingPhase 4
CCTA Evaluation of SGLT2i-related Pericoronary Fat Changes Patients With Stage 4 CKM Syndrome
ACS (Acute Coronary Syndrome), SGLT2 Inhibitors
RecruitingPhase 3
Probucol for Symptomatic Intracranial and Extracranial Artery Stenosis
Ischemic Stroke, TIA
RecruitingObservational study
Gonadal Tissue Freezing for Fertility Preservation in Individuals at Risk for Ovarian Dysfunction, Premature Ovarian Insufficiency and Clinically Indicated Gonadectomy
Turner Syndrome, Post-menarcheal Adolescents
Recruiting
Cardiac RADIoablation Versus Repeat Catheter Ablation: a Pivotal Randomized Clinical Trial Evaluating Safety and Efficacy for Patients With High-risk Refractory Ventricular Tachycardia (RADIATE-VT)
Tachycardia, Ventricular
Active, not recruitingObservational study
Clinical, Laboratory and Epidemiologic Characterization of Individuals and Families at High Risk of Hematologic Cancer
Waldenstrom Macroglobulinemia, Chronic Lymphocytic Leukemia

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.

Pr Eric BRUCKERT study chair

APHP Paris - France, Hôpital La Pitié-Salpétriêre

Mrs Geneviève BONNELYE principal investigator

KantarHealth - France

275 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 Risk, run by AstraZeneca at 275 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 1 inclusion and 0 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 16 Sep 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 275 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.

What does the primary outcome measure?

To evaluate connection between GP's estimation of cardiovascular risk and theoretical calculation (according to guidelines and validated scales (such as risk score profile in the Framingham Heart study or the SCORE risk estimation)) (time frame: At the end of the study). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01039402.

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 16 Sep 2010.