miRNAs in Critical Limb Ischemia (miRNACLI)

Condition(s) studied

Investigational drug(s) / intervention(s)

Critical limb ischemia: analysis of RNAs: analysis of miRNA expression levels

Controls: analysis of RNAs: analysis of miRNAs expression levels

Study summary

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.

Eligibility

Primary outcome measure(s)

• Identification of potentially pathogenic miRNAs in CLI and related target mRNAs. — 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.
• Identification of disease biomarkers — 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.

Trial sites (1)

More IRCCS Policlinico S. Donato trials in Italy

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