Clinical trial NCT02834143: Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia
Official title: Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Stroke
Keywords: vascular
Limb Ischemia
Lead sponsor: Fondation Hôpital Saint-Joseph
Sponsor class: OTHER
First posted: 2016-07-15
Enrollment: 180
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients suffering from peripheral arterial disease of the lower limbs hospitalized in vascular medicine department of GHPSJ (Groupe Hospitalier Paris Saint Joseph) and having a life expectancy greater than one year.

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
timeFrame: Day 1, then Day 45 after hospitalization
measure: Assessent of change of VALMI (French criteria derived vascular medical college)
timeFrame: Day 1, then Day 45 after hospitalization
measure: Assessent of change of the European working group criteria
timeFrame: Day 1, then Day 45 after hospitalization
Secondary outcomes:
measure: Assessent of quality of life
timeFrame: Day 1, then Day 45 after hospitalization
measure: Evaluation of the need for psychological counseling
timeFrame: Day 1, then Day 45 after hospitalization
measure: Evaluation of the interest of a specific bioassay
timeFrame: Day 1, then Day 45 after hospitalization
Other outcomes:
Locations:
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph
state: Ile-de-France
Study officials:
affiliation: Fondation Hôpital Saint-Joseph
name: Michon Pasturel Ulrique, MD
role: PRINCIPAL_INVESTIGATOR
References: