BRUEL
Saint-Etienne, France
NCT Number: NCT04283565
Cardiovascular pathologies (CV), the second leading cause of death just behind tumors, are particularly frequent in France and strongly mobilize the resources of the healthcare system (ambulatory and health facility). The French High Authority for Health (HAS) has defined major cardio-vascular risk factors (CVRF): smoking, high blood pressure (hypertension), elevated total cholesterol (TC) or LDL, decreased HDL cholesterol, type II diabetes and age, and predisposing CVRF or discussed: obesity, sedentary lifestyle, menopause, elevation of triglycerides and genetic factors.
Lower-linb peripherial arterial disease (AOMI), even if asymptomatic, involves systemic atherial disease, responsible for mortality irrespective of the presence of CVRF. The prevalence of asymptomatic AOMI is 10 to 20% beyond 55 years old, and the associated mortality is 18 to 30% at 5 years.
Individual screening is achievable by well-conducted clinical evaluation and systematic measurement of the simple, non-invasive Blood Pressure Index (BPI) in all subjects at risk. A BPI<0.9 indicates an event risk close to that of the symptomatic patient. However, if this strategy is recommended by the HAS, it is not carried out systematically in current practice. Therapeutic means available for the management of an asymptomatic AOMI are the identification and support for controllable CVRF such as smoking and nutrition (diet and physical activity) in the context of secondary prevention of atherosclerosis. Thus, the generalization of a systematique screening strategy of AOMI, allowing faster handling of CVRF by advices and Motivational Interviewing (MI), could have a significant impact, both clinically and economically.
Patients could also benefit from this support in terms of quality of life both on the physiological dimension (effect of weight loss, correction of disorders of cardiac function, etc.), that on the psychic dimension (well-being of patients, management of disorders anxious). However, few studies have evaluated the benefit of such a strategy in terms of quality-adjusted life years (QALYs),none did it on a cost recovery basis. No such studies have been conducted in France.
The feasibility of this project is based on the success of a pilot study conducted in Centre-Val de Loire region (France) in 2013. It showed that the implementation of a strategy of systematic screening of the asymptomatic AOMI based on the measurement of the BPI in high cardiovascular risk patients is feasible in current practice by general practitioners, and could be more efficient than interventions performed in current practice.
Looking for future studies?
Notify Me50 year–90 year
All sexes
Interventional
Not applicable
Saint-Etienne, France
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
CRITERIA FOR INCLUDING PERSONS LENDING TO RESEARCH
Major LIFs:
Other FRCV:
CRITERIA FOR NON-INCLUSION OF PERSONS LENDING TO RESEARCH
The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms
The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms
Time frame: 10 years
Incremental Cost-Utility Ratio (ICUR): Cost per QALY gained at 10 years from the collective and health insurance viewpoint. The quality of life data needed to calculate QALYs will be obtained from the EQ-5D questionnaire and extrapolated to 10 years based on the risk of CV event (SCORE) and prescribed treatments. The costs will be collected by a CRF.
Time frame: 10 years
Incremental Cost-Effectiveness Ratio (ICER): Cost per prevented cardio-vascular event at 10 years from the collective and health insurance viewpoint. CV events at 10 years will be compute from the SCORE calculation at 2 years. The cost will be collected by a CRF.
Time frame: 2 years
ICER: Cost per SCORE point less at 2 years from the collective and health insurance viewpoint. The cost will be collected by a CRF.
Time frame: 5 years
Budget impact at 5 years from the collective and health insurance viewpoint of the dissemination of the most efficient strategy. The cost will be collected by a CRF.
University Hospital, Tours
Other
Health-economic Evaluation of the Care Pathway in General Medicine for High Cardiovascular Risk Patients Based on the Detection of Asymptomatic Lower Limb Peripherial Arterial Disease (AOMI) by the Blood Pressure Index (BPI).
Acronym: DAMAGE
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05858905
Arterial Occlusive Diseases, Arteriosclerosis
Palo Alto, California, United States
View Trial DetailsNCT05009862
Arterial Occlusive Diseases, Arteriosclerosis
Nashville, Tennessee, United States
View Trial DetailsNCT04130737
Arterial Occlusive Diseases, Arteriosclerosis
Mesa, Arizona, United States
View Trial DetailsNCT02471638
Arterial Occlusive Diseases, Arteriosclerosis
Santiago, Chile
View Trial Details