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Sponsored by: |
Assistance Publique - Hôpitaux de Paris |
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Information provided by: | Assistance Publique - Hôpitaux de Paris |
ClinicalTrials.gov Identifier: | NCT00338676 |
Aortic stenosis (AS) is AS is caused by calcium deposits in the aortic valve. Calcification is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. The only treatment is surgery. There are evidences that AS is a regulated process with similarities to atherosclerosis but determinants of AS progression are unknown. The study aims at evaluating these determinants and more specifically the role of lipids, inflammation and platelet aggregation.
Study Type: | Observational |
Study Design: | Cohort, Prospective |
Official Title: | Aortic Stenosis in Elderly : Determinant of Progression. COFRASA (French Cohort) |
blood samples
Estimated Enrollment: | 300 |
Study Start Date: | November 2006 |
Estimated Study Completion Date: | November 2010 |
Aortic stenosis (AS) is the most common valvular disease and the second most common indication for cardiac surgery in Western countries. AS prevalence increases with age and with aging of the population, AS is a major public health problem. AS is due to calcium deposits within the aortic valve. Calcium deposit is progressive and eventually leads to reduced leaflet motion with obstruction of the left ventricular outflow. There is currently no effective medical therapy. Once the stenosis is severe and patients symptomatic, outcome is poor unless surgery (aortic valve replacement) is promptly performed. AS has long been considered as a passive and degenerative process. Recent data challenged this concept, showing that AS is an active and highly regulated process with some similarities to atherosclerosis. However, AS progression is highly variable from one individual to another and determinants of AS progression are poorly known. Their identification is crucial if we want to develop new medical strategies. The aims of the present study are to identify the determinants of AS progression and more specifically to evaluate the role of lipids, inflammation and platelet aggregation.
Ages Eligible for Study: | 70 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Patients diagnosed with an at least mild aortic stenosis with no indication for surgery
Inclusion Criteria:
Exclusion Criteria:
Contact: David Messika-Zeitoun, MD | 00 1 1 40 25 66 01 | david.mesika-zeitoun@bch.aphp.fr |
France | |
Hopital Bichat | Recruiting |
Paris, France, 75018 | |
Contact: David Messika-Zeitoun, MD 00 1 40 25 66 01 david.messika-zeitoun@bch.aphp.fr |
Principal Investigator: | David Messika-Zeitoun, MD | Assistance Publique des Hopitaux de Paris |
Responsible Party: | Department Clinical Research of Developpement ( Christophe AUCAN ) |
Study ID Numbers: | AOM05003 - P051042 |
Study First Received: | June 19, 2006 |
Last Updated: | May 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00338676 |
Health Authority: | France: National Consultative Ethics Committee for Health and Life Sciences |
Aortic stenosis Elderly |
Pathological Conditions, Anatomical Heart Diseases Disease Progression Constriction, Pathologic |
Aortic valve stenosis Aortic Valve Stenosis Heart Valve Diseases |
Cardiovascular Diseases Ventricular Outflow Obstruction |