Peripheral Arterial DiseaseDAMAGENCT04283565
Cost-utility Analysis, Cost-effectiveness Analysis, Budget Impact Analysis
A study testing Systematic screening of AOMI by BPI measurement. and Management of CVRF by a motivationnal interviewing. in people with Peripheral Arterial Disease, run by University Hospital, Tours at 1 site in France.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 50 to 90 years
- Conditions the study is for
- Peripheral Arterial Disease
- What is being tested?
- Systematic screening of AOMI by BPI measurement. and Management of CVRF by a motivationnal interviewing.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 614 participants
- Where
- 1 siteFrance
- Study dates
- 23 Apr 2021to 18 Apr 2025
- Phase
- Interventional
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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- Active or withdrawn smoking for less than 1 year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
Trial locations and contacts
1 site in 1 country.
About this study
Official 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).
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.
Read more
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.
- Conditions
- Peripheral Arterial Disease
- Being tested
- Systematic screening of AOMI by BPI measurement., Management of CVRF by a motivationnal interviewing.
- Keywords
- detection, cost-utility analysis, cost-effectiveness analysis, blood pressure index measurement, motivational interviewing
- Medical subject headings
- Peripheral Arterial Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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
| Study group | Role | What they receive |
|---|---|---|
| Strategy 1: Usual practice | No intervention | No systematic screening of asymptomatic AOMI and routine management of FRCV. |
| Strategy 2: Motivationnal interviewing | Experimental | No systematic screening of asymptomatic AOMI and management of CVRF by a motivationnal interviewing. Receives: Other: Management of CVRF by a motivationnal interviewing. |
| Strategy 3: Systematic screening of AOMI by BPI measurement | Experimental | Systematic screening of AOMI by BPI measurement and routine management of FRCV. Receives: Other: Systematic screening of AOMI by BPI measurement. |
| Strategy 4: Both strategies | Experimental | Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing. Receives: Other: Systematic screening of AOMI by BPI measurement.; Other: Management of CVRF by a motivationnal interviewing. |
What is being measured
The primary outcome is the main question the study is designed to answer.
ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
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.
Measured: 10 years
Secondary outcomes (3)
ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
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.
Measured: 10 years
ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
ICER: Cost per SCORE point less at 2 years from the collective and health insurance viewpoint. The cost will be collected by a CRF.
Measured: 2 years
Budget impact (in €) at 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.
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2020
- Study start23 Apr 2021
- Primary completion18 Apr 2023
- Study completion18 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peripheral Arterial DiseaseStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Two strategies are studied in this study: * Screening for asymptomatic AOMI by measuring IPS * Management of the FRCV by advices and motivational interviewing The strategies will be associated according to a factorial plan 2 \* 2 in order to obtain 4 groups: * Strategy 1: Routine testing for asymptomatic AOMI and management of FRCV. * Strategy 2: Routine practice of asymptomatic AOMI screening and management of FRCVs by councils and a MA. * Strategy 3: Systematic Screening of asymptomatic AOMI by measurement of SPI and routine management of FRCV. * Strategy 4: Systematic screening of asymptomatic AOMI by measuring SPI and taking care of FRCVs by councils and a ME.
- Masking
- None (open label)
- Enrolment
- 614 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Tours
- Sponsor type
- University, hospital or other
- Collaborators
- Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ, Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure, Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST, Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise, Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE, Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND, Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS, Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes
- Responsible party
- Sponsor
- Investigators
- Sebastien BRUEL, Dr, Principal investigator, CRMG SAINT ETIENNEClarisse Dr DIBAO DINA, Dr, Principal investigator, CRMG TOURSThierry FARGE, Pr, Principal investigator, CRMG LYONSophie LALANDE, Dr, Principal investigator, CRMG BRESTMichel CUNIN, Dr, Principal investigator, CRMG LILLEPhilippe VORILHON, Dr, Principal investigator, CRMG CLERMONT FERRANDDelphine RUBÉ, Dr, Principal investigator, CRMG NANTES 44000Emmanuel ALLORY, Dr, Principal investigator, CRMG RENNES Coordinateur régional 53 CCAL PRESIDENT KENNEDY 35000 RENNES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04283565
- Sponsor's protocol ID
- PRM16-ER-DAMAGE
- Acronym
- DAMAGE
- Status last verified
- Jun 2026
- First submitted
- 11 Jun 2019
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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).
- ClinicalTrials.gov ID
- NCT04283565
- Acronym / sponsor ID
- DAMAGE / PRM16-ER-DAMAGE
- Conditions
- Peripheral Arterial Disease
- Keywords
- detection, cost-utility analysis, cost-effectiveness analysis, blood pressure index measurement, motivational interviewing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 614 participants (actual)
- Lead sponsor
- University Hospital, ToursUniversity, hospital or other
- Collaborators
- Collèges Régionaux de Médecine Générale- CRMG - 42270 ST PRIEST EN JAREZ, Collèges Régionaux de Médecine Générale- CRMG - 26330 Châteauneuf-de-Galaure, Collèges Régionaux de Médecine Générale- CRMG - 29238 BREST, Collèges Régionaux de Médecine Générale- CRMG - 37400 Amboise, Collèges Régionaux de Médecine Générale- CRMG - 59110 LA MADELEINE, Collèges Régionaux de Médecine Générale- CRMG - 63 001 CLERMONT FERRAND, Collèges Régionaux de Médecine Générale- CRMG - 18600 SANCOINS, Collèges Régionaux de Médecine Générale- CRMG - 35000 Rennes
- Study start
- 23 Apr 2021 (actual)
- Primary completion
- 18 Apr 2023 (actual)
- Study completion
- 18 Apr 2025 (actual)
- First posted
- 25 Feb 2020 (actual)
- 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.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
- Model description
- Two strategies are studied in this study: * Screening for asymptomatic AOMI by measuring IPS * Management of the FRCV by advices and motivational interviewing The strategies will be associated according to a factorial plan 2 * 2 in order to obtain 4 groups: * Strategy 1: Routine testing for asymptomatic AOMI and management of FRCV. * Strategy 2: Routine practice of asymptomatic AOMI screening and management of FRCVs by councils and a MA. * Strategy 3: Systematic Screening of asymptomatic AOMI by measurement of SPI and routine management of FRCV. * Strategy 4: Systematic screening of asymptomatic AOMI by measuring SPI and taking care of FRCVs by councils and a ME.
| Arm | Type | Receives |
|---|---|---|
| Strategy 1: Usual practice | No intervention | –No systematic screening of asymptomatic AOMI and routine management of FRCV. |
| Strategy 2: Motivationnal interviewing | Experimental | Other: Management of CVRF by a motivationnal interviewing.No systematic screening of asymptomatic AOMI and management of CVRF by a motivationnal interviewing. |
| Strategy 3: Systematic screening of AOMI by BPI measurement | Experimental | Other: Systematic screening of AOMI by BPI measurement.Systematic screening of AOMI by BPI measurement and routine management of FRCV. |
| Strategy 4: Both strategies | Experimental | Other: Systematic screening of AOMI by BPI measurement., Other: Management of CVRF by a motivationnal interviewing.Systematic screening of AOMI by BPI measurement and management of CVRF by a motivationnal interviewing. |
Who may qualify
- Ages
- 50 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic screening of AOMI by BPI measurement.The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms | Other | Strategy 3: Systematic screening of AOMI by BPI measurement, Strategy 4: Both strategies |
| Management of CVRF by a motivationnal interviewing.The strategies will be associated according to a 2*2 factorial design in order to obtain 4 arms | Other | Strategy 2: Motivationnal interviewing, Strategy 4: Both strategies |
Primary outcome
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.
3 secondary outcomes
ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
Time frame: 10 years
ICER between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors.
Time frame: 2 years
Budget impact (in €) at 5 years
Time frame: 5 years
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 Jun 2026.
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Peripheral Arterial Disease
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.
Sebastien BRUEL, Dr principal investigator
CRMG SAINT ETIENNE
Clarisse Dr DIBAO DINA, Dr principal investigator
CRMG TOURS
Thierry FARGE, Pr principal investigator
CRMG LYON
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic screening of AOMI by BPI measurement. and Management of CVRF by a motivationnal interviewing. in people with Peripheral Arterial Disease, run by University Hospital, Tours at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
ICUR between different screening and management strategies of peripherial arterial disease and cardio-vascular risk factors. (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jun 2026.