Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease

NCT07588295 | Recruiting

• 1 other identifier: LAST COP
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Numerous clinical studies have highlighted the role of macrophages in the destabilization of coronary lesions; however, there is limited literature on the relationship between circulating monocytes and intraplaque macrophages. This study aims to evaluate and compare the presence of macrophages and their subsequent activation within coronary and peripheral atherosclerotic lesions, and to correlate these findings with the distribution of circulating monocyte subpopulations.

Conditions

Stable Coronary Artery Disease; Critical Limb Ischemia; Intermittent Claudication; Acute Coronary Syndromes

Outcome Measures

Primary Outcomes (1)

• presence of macrophages and their activation within coronary and peripheral atherosclerotic lesions

  To evaluate and compare the presence of macrophages and their subsequent activation within coronary and peripheral atherosclerotic lesions (using OCT imaging), and to correlate these findings with the distribution of circulating monocyte subpopulations.

  From enrollment to hospital discharge following peripheral angiography/coronary angiography

Study Arms (4)

Stable coronary artery disease

OTHER

Diagnostic Test: Optical Coherence Tomography assessment

Acute coronary syndrome

OTHER

Diagnostic Test: Optical Coherence Tomography assessment

Intermittent claudication

OTHER

Diagnostic Test: Optical Coherence Tomography assessment

Critical limb ischemia

OTHER

Diagnostic Test: Optical Coherence Tomography assessment

Interventions

Optical Coherence Tomography assessment DIAGNOSTIC_TEST

assessment of the number of infiltrating macrophages

Acute coronary syndrome; Critical limb ischemia; Intermittent claudication; Stable coronary artery disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with chronic coronary artery disease;
• Patients with no-ST elevation acute coronary syndrome;
• Patients with chronic claudication (Rutherford II-III)
• Patients with critical limb ischemia (Rutherford IV-V).

You may not qualify if:

• Severe renal dysfunction
• Severe valve disease
• Advanced heart failure
• Advanced liver disease
• Chronic inflammatory or autoimmune disease
• Use of antinflammatory drugs
• Acute infection
• Recent surgical procedures

Sponsors & Collaborators

• Maria Cecilia Hospital: lead

Study Sites (1)

Maria Cecilia Hospital

Cotignola, Ravenna, 48033, Italy

RECRUITING

MeSH Terms

Conditions

Acute Coronary Syndrome; Chronic Limb-Threatening Ischemia; Intermittent Claudication

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Roberto Nerla, MD, PhD

CONTACT

+390545217032; robertonerla83@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 28, 2026
• First Posted: May 14, 2026
• Study Start: March 18, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 14, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)