miRNAs in Critical Limb Ischemia (miRNACLI)
ConditionCritical Limb Ischemia
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-85
SponsorIRCCS Policlinico S. Donato
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
Pregnant women
Patients carriers of genetic diseases
Patients suffering from malignant neoplasia
Trial population
Critical limb ischemia patients
Trial design
Design model
Case-control
Time perspective
Retrospective
Treatments tested in this trial
Critical limb ischemia: analysis of RNAs
Diagnostic testanalysis of miRNA expression levels
Controls: analysis of RNAs
Diagnostic testanalysis of miRNAs expression levels
Treatment groups
80 Participants
are divided into 2 treatment groupsGroup A: 1) Critical limb ischemia (CLI);1 intervention
Group B: 2)Controls1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year to 10 years2
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.
Time frame
1 year to 10 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov