Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Enrollment
- 180
- Locations
- 1
- Primary Endpoint
- Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
Study Overview
Brief Summary
Chronic critical limb ischemia (CCI) is the most severe clinical form of occlusive arterial disease. Its prognosis is terrible, mortality estimated at 50% in five years. However there are no recent epidemiological data on morbidity and mortality of critical ischemia. Moreover, the diagnostic criteria of the ICC associate clinical and hemodynamic criteria and are not subject to a clear consensus.
Investigators propose to evaluate the validated diagnostic criteria (TASC VALMI, European working group) in a population of severe ischemia in patients in order to offer relevant simple and reproducible criteria. Secondly Investigators propose to monitor the medium and long term evolution of these patients ICC defined to clarify the prognosis.
diagnostic criteria of the different societies:
- TASC: Transatlantic criteria: very characteristic pain, wound optional, variable hemodynamic criteria as the presence of a wound or not
- VALMI: French criteria derived vascular medical college: characteristic pain, sore, hemodynamic reproducible, reliable criteria
- European working group: European definition of criteria, including a characteristic pain, requires no wound, different hemodynamic criteria of 2 others.
Detailed Description
Main objective / secondary:
-
Main objective: Evaluation of diagnostic criteria for chronic critical limb ischemia
-
Secondary objectives:
-
Evaluation of the quality of life,
-
Evaluation of the need for psychological counseling a patient at the stage of chronic critical limb ischemia,
-
Evaluation of the interest of a specific bioassay
Development of the study:
The offer document and the non-opposition of the patient will be collected on the first day of hospitalization, quality of life questionnaires will also be distributed at the beginning of hospitalization.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ and having a life expectancy greater than one year.
Exclusion Criteria
- •demented patient psychological condition
Outcomes
Primary Outcomes
Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
Time Frame: Day 1, then Day 45 after hospitalization
Assessent of change of VALMI (French criteria derived vascular medical college)
Time Frame: Day 1, then Day 45 after hospitalization
French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable
Assessent of change of the European working group criteria
Time Frame: Day 1, then Day 45 after hospitalization
European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.
Secondary Outcomes
- Assessent of quality of life(Day 1, then Day 45 after hospitalization)
- Evaluation of the need for psychological counseling(Day 1, then Day 45 after hospitalization)
- Evaluation of the interest of a specific bioassay(Day 1, then Day 45 after hospitalization)