重症虚血肢における miRNA (miRNACLI) (miRNACLI)
重症虚血肢におけるマイクロRNAの役割
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Fabio Dr Martelli
- 電話番号：+39 0226437762
- メール：fabio.martelli@grupposandonato.it
研究連絡先のバックアップ
- 名前：Giovanni Dr Nano, MD
- 電話番号：+39 0252771
- メール：giovanni.nano@grupposandonato.it
研究場所
-
-
Milan
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San Donato Milanese、Milan、イタリア、20097
- 募集
- Irccs Policlinico San Donato
-
副調査官：
- Giovanni Nano, MD
-
副調査官：
- Paolo Righini, MD
-
コンタクト：
- FABIO MARTELLI, PhD
- 電話番号：0252774683
- メール：fabio.martelli@grupposandonato.it
-
-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Critical limb ischemia patients
説明
Inclusion Criteria:
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.
Exclusion Criteria:
- Pregnant women
- Patients carriers of genetic diseases
- Patients suffering from malignant neoplasia
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：CASE_CONTROL
- 時間の展望：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
1) Critical limb ischemia (CLI);
1)Critical limb ischemia (CLI):
|
analysis of miRNA expression levels |
|
2)Controls
2)Controls: patients 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. |
analysis of miRNAs expression levels |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Identification of potentially pathogenic miRNAs in CLI and related target mRNAs.
時間枠：1 year to 10 years
|
Identify miRNAs and their targets that directly interact with the RNA Induced Silencing Complex (RISC) in muscle biopsies obtained from CLI patients. |
1 year to 10 years
|
|
Identification of disease biomarkers
時間枠：1 year to 10 years
|
Identify plasma miRNAs to be used as disease biomarkers that can be used to assess disease status and severity with a minimally invasive procedure. |
1 year to 10 years
|
協力者と研究者
捜査官
- 主任研究者：Fabio Martelli、IRCCS Policlinico S. Donato
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- miRNACLI
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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