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Completed

NCT Number: NCT04283565

Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis

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.

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Key information

Age range

50 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

BRUEL

Saint-Etienne, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

CRITERIA FOR INCLUDING PERSONS LENDING TO RESEARCH

  • Man over 50 years old and under 80 years old or woman over 60 years old and under 90 years old with at least 2 FRCV including at least 1 major FRCV:

Major LIFs:

  • Active or withdrawn smoking for less than 1 year
  • Type 2 diabetes, treated or not

Other FRCV:

  • Family history: MI, coronary revascularization or sudden death before age 50 with a 1st degree parent
  • Dyslipidemia: LDL-cholesterol> 1.3 g / l and / or HDL-cholesterol <0.4 g / l
  • hypertension (≥ 140/90 mmHg) for at least 6 months, balanced or not
  • Sedentary lifestyle
  • Obesity
  • Ability to benefit from an EM and to complete a quality of life questionnaire (mastery and understanding of the French language)
  • Patient affiliated or beneficiary of a social security scheme
  • Patient who has expressed informed consent

CRITERIA FOR NON-INCLUSION OF PERSONS LENDING TO RESEARCH

  • History of cardiovascular event (symptomatic PADI, acute coronary syndrome, stroke, transient ischemic attack, etc.), therefore patient already in tertiary prevention
  • Patient participating in another interventional study.
  • Known asymptomatic PADI

Treatment and study plan

Systematic screening of AOMI by BPI measurement.

Other

The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms

Management of CVRF by a motivationnal interviewing.

Other

The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms

Primary outcomes

  1. ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.

    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.

Secondary outcomes

  1. ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.

    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.

  2. ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.

    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.

  3. Budget impact (in €) at 5 years

    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.

Sponsors and collaborators

Lead sponsor

University Hospital, Tours

Other

Collaborators

  • Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS
  • Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure
  • Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST
  • Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes
  • Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise
  • Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ
  • Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE
  • Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Feb 25, 2020
Registry last updated
Jun 16, 2026

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.

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