Идёт набор NCT06066268

miRNAs in Critical Limb Ischemia (miRNACLI)

— Наблюдательное Critical Limb Ischemia

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Critical limb ischemia: analysis of RNAs, Controls: analysis of RNAs.
Кому может быть актуально: Состояния в реестре: Critical Limb Ischemia. Базовые параметры: 40 лет — 85 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: Италия
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Role of microRNAs in Critical Limb Ischemia

Обзор

For the present study, 40 patients affected by critical limb ischemia of different severity will be enrolled: patients affected by critical limb ischemia undergoing subgenual femoropopliteal bypass; patients suffering from terminal ischemia causing gangrene and therefore undergoing major amputation of the lower limb. Biopsies from the first 20 enrolled patients will be used for miRNA profiling. The total of 40 biopsies obtained from all enrolled patients will instead be used for the validation of the miRNAs identified in the profiling. The results obtained will be compared with those obtained in 40 control patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery (EVAR) of the AAA without any ischemia of the lower limbs. Also in this case the biopsies of the first 20 control patients enrolled will be used for miRNA profiling. The total of 40 biopsies obtained from all control patients will instead be used for the validation of the miRNAs identified in the profiling. A total of 80 patients (40 cases and 40 controls) will be enrolled.

Подробное описание

The analyzes of the expression of miRNAs and the RISC complex will be carried out on fragments of skeletal muscle taken from different sites depending on whether they are cases or controls.

Cases:

* Patients suffering from CLI undergoing lower limb revascularization via subgenual femoropopliteal bypass: Gastrocnemius muscle biopsies will be taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing thigh amputation: biopsies will be taken in different muscle districts. In particular, biopsies of the Sartorius or Vastus lateralis muscle will be taken at the amputation site, both from the proximal muscle belly which remains covering the bone stump, and from the part of the muscle belly sacrificed with the amputated limb. Biopsies of the Gastrocnemius and Tibialis anterior muscles will be taken from the amputated leg. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing leg amputation: biopsies will be taken in different muscle districts. In particular, biopsies of the Gastrocnemius and Tibialis anterior muscles will be carried out at the amputation site, both from the proximal muscle belly which remains covering the bone stump, and from the part of the muscle belly sacrificed with the amputated limb.

Controls:

• The control subjects will be represented by individuals affected by infrarenal abdominal aortic aneurysm (AAA) free from CLI, affected and not affected by type 2 diabetes mellitus, undergoing endovascular exclusion surgery of the AAA (EVAR), similar by age and sex to CLI patients. Sartorius muscle biopsies will be taken.

The analyzes of the expression of circulating miRNAs will be carried out on 2 7 ml tubes of peripheral venous blood, taken before the surgical incision from the same cases and controls described in the previous point.

Вмешательства

Диагностический тест Critical limb ischemia: analysis of RNAs
analysis of miRNA expression levels
Диагностический тест Controls: analysis of RNAs
analysis of miRNAs expression levels

Первичные конечные точки

Identification of potentially pathogenic miRNAs in CLI and related target mRNAs. [Срок оценки: 1 year to 10 years]
Identification of disease biomarkers [Срок оценки: 1 year to 10 years]

Критерии участия

Критерии включения

Cases:

patients affected by CLI candidates for popliteal exploration surgery and/or subgenual femoropopliteal bypass.
Patients affected by CLI with irreversible ischemia and/or distal gangrene of the lower limb candidates for major amputation of the lower limb.

Controls:

patients affected by infrarenal abdominal aortic aneurysm (AAA) undergoing endovascular exclusion surgery of the AAA (EVAR) who are free from CLI, affected and not affected by type 2 diabetes mellitus.