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RecruitingNCT07588295Updated May 14, 2026

Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease

An interventional study of Optical Coherence Tomography assessment in Stable Coronary Artery Disease, Acute Coronary Syndromes and Critical Limb Ischemia, sponsored by Maria Cecilia Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by Maria Cecilia Hospital · Not applicable, Interventional, and Diagnostic

From the registry’s dates

  • Registered 2 years 1 month after the study started (first participant enrolled Mar 2024, registered Apr 2026).
  • Started Mar 2024; still recruiting 2 years 7 months later.
Phase
Not applicable
Study type
Interventional
Enrollment
60
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Stable Coronary Artery Disease
  • Acute Coronary Syndromes
  • Critical Limb Ischemia
  • Intermittent Claudication
03

In context

Acute Coronary Syndrome

1,488 studies on the registry are indexed under Acute Coronary Syndrome; 273 are open to participants now.

This study's planned enrollment of 60 is below the median of 200 across 865 interventional studies indexed under Acute Coronary Syndrome.

Browse Acute Coronary Syndrome studies →

Lead sponsor

Maria Cecilia Hospital is the lead sponsor of 17 studies on the registry; 8 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Severe renal dysfunction
  • Severe valve disease
  • Advanced heart failure
  • Advanced liver disease
  • Chronic inflammatory or disease
  • Use of antinflammatory drugs
  • Acute infection
  • Recent surgical procedures
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Other
    Stable coronary artery disease

    Diagnostic Test: Optical Coherence Tomography assessment

  • Other
    Acute coronary syndrome

    Diagnostic Test: Optical Coherence Tomography assessment

  • Other
    Intermittent claudication

    Diagnostic Test: Optical Coherence Tomography assessment

  • Other
    Critical limb ischemia

    Diagnostic Test: Optical Coherence Tomography assessment

Interventions

  • Diagnostic testOptical Coherence Tomography assessment

    assessment of the number of infiltrating macrophages

06

What researchers measure

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.

    Time frame: From enrollment to hospital discharge following peripheral angiography/coronary angiography

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Mar 2024 (actual). Primary completion is estimated for Dec 2026, 33 months after the start.

Of 210 non-industry interventional studies with no phase under Acute Coronary Syndrome, half reached primary completion within 34 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 46. This study's planned 33 months is close to that.

Counting every sponsor, half of 225 studies reached it within 34 months; a quarter within 18 and three quarters within 46.

How these figures are worked out, and which studies are left out of them.

Registered
Apr 28, 2026
First posted
May 14, 2026
StartActual
Mar 18, 2024
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
May 14, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07588295
Lead sponsor
Maria Cecilia Hospital
Responsible party
Sponsor
First posted
May 14, 2026
Start date
Mar 18, 2024
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
May 14, 2026

Study contacts

Roberto Nerla, MD, PhD
Contact
robertonerla83@gmail.com
+390545217032

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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