miRNAs in Critical Limb Ischemia (miRNACLI)

NCT06066268 | Recruiting

• 1 other identifier: miRNACLI
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Critical Limb Ischemia

Keywords

microRNA; Ischemia

Outcome Measures

Primary Outcomes (2)

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

  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

  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

Study Arms (2)

1) Critical limb ischemia (CLI);

1)Critical limb ischemia (CLI): * Patients suffering from CLI undergoing lower limb revascularization via subgenual femoropopliteal bypass. muscle biopsies willbe taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing thigh amputation. Muscle biopsies will be taken. * Patients suffering from terminal CLI and/or gangrene of the lower limb undergoing leg amputation. Muscle biopsies will be taken.

Diagnostic Test: Critical limb ischemia: analysis of RNAs

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.

Diagnostic Test: Controls: analysis of RNAs

Interventions

Critical limb ischemia: analysis of RNAs DIAGNOSTIC_TEST

analysis of miRNA expression levels

1) Critical limb ischemia (CLI);

Controls: analysis of RNAs DIAGNOSTIC_TEST

analysis of miRNAs expression levels

2)Controls

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Critical limb ischemia patients

You may qualify if:

• 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:

You may not qualify if:

• Pregnant women
• Patients carriers of genetic diseases
• Patients suffering from malignant neoplasia

Sponsors & Collaborators

• IRCCS Policlinico S. Donato: lead

Study Sites (1)

Irccs Policlinico San Donato

San Donato Milanese, Milan, 20097, Italy

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

muscle biopsis

MeSH Terms

Conditions

Chronic Limb-Threatening Ischemia; Ischemia

Condition Hierarchy (Ancestors)

Peripheral Arterial Disease; Atherosclerosis; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases; Cardiovascular Diseases; Peripheral Vascular Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Fabio Martelli

  IRCCS Policlinico S. Donato

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Fabio Dr Martelli

CONTACT

+39 0226437762; fabio.martelli@grupposandonato.it

Giovanni Dr Nano, MD

CONTACT

+39 0252771; giovanni.nano@grupposandonato.it

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: September 27, 2023
• First Posted: October 4, 2023
• Study Start: May 31, 2016
• Primary Completion: May 31, 2026
• Study Completion: May 31, 2026
• Last Updated: April 30, 2025

Record last verified: 2025-04

Locations

IT (1)