Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia

Stroke Clinical Trial

— CRIMI  

Official title:

Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02834143
• Other study ID #: CRIMI
• Status: Completed
• Phase: N/A
• First received: July 7, 2016
• Last updated: February 21, 2017
• Start date: June 13, 2014
• Est. completion date: June 14, 2015

Study information

• Verified date: July 2016
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 180
• Est. completion date: June 14, 2015
• Est. primary completion date: January 14, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemia
• Stroke

Intervention

Other:
• No intervention
The is no intervention. This study is a descriptive one

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint Joseph	Paris	Ile-de-France

Sponsors (1)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)		Day 1, then Day 45 after hospitalization
Primary	Assessent of change of VALMI (French criteria derived vascular medical college)	French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable	Day 1, then Day 45 after hospitalization
Primary	Assessent of change of the European working group criteria	European definition of criteria, including a characteristic pain, requires no wound, different haemodynamic criteria 2 others.	Day 1, then Day 45 after hospitalization
Secondary	Assessent of quality of life	Quality of Life questionnaire validated by the French Society of Angiology (SF 12)	Day 1, then Day 45 after hospitalization
Secondary	Evaluation of the need for psychological counseling	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
Secondary	Evaluation of the interest of a specific bioassay	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