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NCT Number: NCT02834143

Evaluation of Diagnostic Criteria for Chronic Critical Limb Ischemia

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.

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Key information

Conditions

Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Groupe Hospitalier Paris Saint Joseph

Paris, Île-de-France Region, 75014, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

No intervention

Other

The is no intervention. This study is a descriptive one

Primary outcomes

  1. 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

  2. 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

  3. 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

  1. Assessent of quality of life

    Time frame: Day 1, then Day 45 after hospitalization

    Quality of Life questionnaire validated by the French Society of Angiology (SF 12)

  2. Evaluation of the need for psychological counseling

    Time frame: 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

  3. Evaluation of the interest of a specific bioassay

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Fondation Hôpital Saint-Joseph

Other

Registry information

Acronym: CRIMI

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Jul 15, 2016
Registry last updated
Feb 23, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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