To Assess the Predictive Value of D-dimer Level on the Occurrence of Cardiovascular Events (COAGFAII)

This study has been completed.

Sponsor:

Collaborator:

Ministry of Health, France

Information provided by:

Hopital Lariboisière

ClinicalTrials.gov Identifier:

NCT01224574

First received: September 13, 2010

Last updated: October 19, 2010

Last verified: September 2010

History of Changes

Purpose

The primary aim of the study was to assess whether D-Dimer level at entry or an increase of D-Dimer level during the follow-up could predict the occurrence of subsequent cardiovascular events in patients with atrial fibrillation.

Condition
Atrial Fibrillation

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Place Des D-dimères Dans la Prise en Charge Des Patients en Fibrillation Auriculaire : Evaluation de la Valeur prédictive Des D-dimères Sur la Survenue d'événements Thromboemboliques

Resource links provided by NLM:

Genetics Home Reference related topics: familial atrial fibrillation

MedlinePlus related topics: Atrial Fibrillation

U.S. FDA Resources

Further study details as provided by Hopital Lariboisière:

Biospecimen Retention: Samples Without DNA

No biospecimens are to be retained

Enrollment:	425
Study Start Date:	January 2001
Study Completion Date:	July 2007
Primary Completion Date:	July 2006 (Final data collection date for primary outcome measure)

Detailed Description:

Patients will be followed-up every 4 months with clinical assessment and D-dimer blinded measurement.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients with atrial fibrillation encountered in usual care

Criteria

Inclusion Criteria:

atrial fibrillation

Exclusion Criteria:

follow-up not possible, poor prognosis within 3 months

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01224574

Locations

France
AP HP
Paris, France

Sponsors and Collaborators

Hopital Lariboisière

Ministry of Health, France

Investigators

Principal Investigator:

Isabelle Mahé, MD,PhD

Hopital Lariboisière

More Information

Publications:

Mahé I, Drouet L, Simoneau G, Minh-Muzeaux S, Caulin C, Bergmann JF. D-dimer can predict survival in patients with chronic atrial fibrillation. Blood Coagul Fibrinolysis. 2004 Jul;15(5):413-7.

Mahé I, Drouet L, Chassany O, Mazoyer E, Simoneau G, Knellwolf AL, Caulin C, Bergmann JF. D-dimer: a characteristic of the coagulation state of each patient with chronic atrial fibrillation. Thromb Res. 2002 Jul 15;107(1-2):1-6.

Mahé I, Grenard AS, Joyeux N, Caulin C, Bergmann JF. Management of oral anticoagulant in clinical practice: a retrospective study of 187 patients. J Gerontol A Biol Sci Med Sci. 2004 Dec;59(12):1339-42.

Lafuente-Lafuente C, Mahé I, Extramiana F. Management of atrial fibrillation. BMJ. 2009 Dec 23;339:b5216. Review. No abstract available.

Responsible Party:	Projet Hospitalier de Recherche Clinique Régional, Direction de la Recherche Clinique
ClinicalTrials.gov Identifier:	NCT01224574 History of Changes
Other Study ID Numbers:	AOR 01 029
Study First Received:	September 13, 2010
Last Updated:	October 19, 2010
Health Authority:	France: Ministry of Health

Keywords provided by Hopital Lariboisière:

atrial fribrillation, cardiovascular events, aging, D-dimer

Additional relevant MeSH terms:

Atrial Fibrillation
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on May 16, 2013

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