Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia (CRIMI)
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.
Descripción general del estudio
Descripción detallada
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.
Clinical data will be collected during hospitalization of the patient, respecting their anonymity, only the place of birth shall be retained in terms of data that distinguish patients.
During the consultation of control, a half months post-hospitalization, diagnostic criteria will be reviewed and the quality of life (using the same questionnaire) and the need or not for psychological help (oral question).
The doctor will be called between 3 and 6 months following hospitalization to assess her patient monitoring criteria, rhythm monitoring, the psychological impact of the disease on the patient seen by the physician, assessment loss of independence due to illness.
The number of hospitalizations for chronic critical ischemia of six months shall be obtained.
Methodology :
Design: Prospective, mono centric, non-interventional (observational) consecutive patients attending the service Vascular Medicine.
Study duration: 6 months: about 150 to 180 patients included in the study, about 50 have clinical chronic critical limb ischemia criteria.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Ile-de-France
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Paris, Ile-de-France, Francia, 75014
- Groupe hospitalier Paris saint Joseph
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
Periodo de tiempo: Day 1, then Day 45 after hospitalization
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Day 1, then Day 45 after hospitalization
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Assessent of change of VALMI (French criteria derived vascular medical college)
Periodo de tiempo: Day 1, then Day 45 after hospitalization
|
French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable
|
Day 1, then Day 45 after hospitalization
|
|
Assessent of change of the European working group criteria
Periodo de tiempo: Day 1, then Day 45 after hospitalization
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European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.
|
Day 1, then Day 45 after hospitalization
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Assessent of quality of life
Periodo de tiempo: Day 1, then Day 45 after hospitalization
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Quality of Life questionnaire validated by the French Society of Angiology (SF 12)
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Day 1, then Day 45 after hospitalization
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Evaluation of the need for psychological counseling
Periodo de tiempo: Day 1, then Day 45 after hospitalization
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Evaluation of the need of the patient for psychological counseling at the stage of chronic critical limb ischemia: questions posed orally directly to the patient "do you feel the need for psychological counseling? "(When viewing control, a month and a half after hospitalization) Possible answers are : yes or no |
Day 1, then Day 45 after hospitalization
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Evaluation of the interest of a specific bioassay
Periodo de tiempo: Day 1, then Day 45 after hospitalization
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Evaluation of the interest of a specific bioassay: no additional assay carried out for the study, only biologies prescribed as part of its usual management will be carried out Possible answers are : yes or no |
Day 1, then Day 45 after hospitalization
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Michon Pasturel Ulrique, MD, Groupe hospitalier Paris saint Joseph
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- CRIMI
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
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