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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
Ile-de-France
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Paris, Ile-de-France, France, 75014
- Groupe Hospitalier Paris Saint Joseph
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-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
Délai: Day 1, then Day 45 after hospitalization
|
Day 1, then Day 45 after hospitalization
|
|
|
Assessent of change of VALMI (French criteria derived vascular medical college)
Délai: 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
Délai: Day 1, then Day 45 after hospitalization
|
European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.
|
Day 1, then Day 45 after hospitalization
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Assessent of quality of life
Délai: Day 1, then Day 45 after hospitalization
|
Quality of Life questionnaire validated by the French Society of Angiology (SF 12)
|
Day 1, then Day 45 after hospitalization
|
|
Evaluation of the need for psychological counseling
Délai: Day 1, then Day 45 after hospitalization
|
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
|
|
Evaluation of the interest of a specific bioassay
Délai: Day 1, then Day 45 after hospitalization
|
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
|
Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Chercheur principal: Michon Pasturel Ulrique, MD, Groupe Hospitalier Paris Saint Joseph
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CRIMI
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
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