Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease

May 11, 2026 updated by: Maria Cecilia Hospital

Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease: the LAST-COP Study

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Italy
    • Ravenna
      • Cotignola, Ravenna, Italy, 48033
        • Recruiting
        • Maria Cecilia Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Stable coronary artery disease
Diagnostic test: Optical Coherence Tomography assessment
assessment of the number of infiltrating macrophages
Other: Acute coronary syndrome
Diagnostic test: Optical Coherence Tomography assessment
assessment of the number of infiltrating macrophages
Other: Intermittent claudication
Diagnostic test: Optical Coherence Tomography assessment
assessment of the number of infiltrating macrophages
Other: Critical limb ischemia
Diagnostic test: Optical Coherence Tomography assessment
assessment of the number of infiltrating macrophages

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
presence of macrophages and their activation within coronary and peripheral atherosclerotic lesions
Time Frame: From enrollment to hospital discharge following peripheral angiography/coronary angiography
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Maria Cecilia Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 18, 2024

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

April 28, 2026

First Submitted That Met QC Criteria

May 11, 2026

First Posted (Actual)

May 14, 2026

Study Record Updates

Last Update Posted (Actual)

May 14, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LAST COP

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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