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.
연구 개요
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Ile-de-France
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Paris, Ile-de-France, 프랑스, 75014
- Groupe hospitalier Paris saint Joseph
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessent of change of The Trans-Atlantic Inter-Society Consensus Document on Management of Peripheral Arterial Disease (TASC)
기간: 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)
기간: Day 1, then Day 45 after hospitalization
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French criteria derived vascular medical college: characteristic pain, sore, reproducible hemodynamic criteria, reliable
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Day 1, then Day 45 after hospitalization
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Assessent of change of the European working group criteria
기간: 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.
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Day 1, then Day 45 after hospitalization
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Assessent of quality of life
기간: 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
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Michon Pasturel Ulrique, MD, Groupe hospitalier Paris saint Joseph
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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