Stable Coronary Artery DiseaseNCT07588295
Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease
A study testing Optical Coherence Tomography assessment in people with Stable Coronary Artery Disease and Acute Coronary Syndromes, run by Maria Cecilia Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia
- What is being tested?
- Optical Coherence Tomography assessment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 18 Mar 2024to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Maria Cecilia Hospital
Cotignola, Ravenna, 48033
Roberto Nerla, MD, PhD, +390545217032, robertonerla83@gmail.com
About this study
Official title: 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.
- Conditions
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia, Intermittent Claudication
- Being tested
- Optical Coherence Tomography assessment
- Medical subject headings
- Acute Coronary Syndrome, Chronic Limb-Threatening Ischemia, Intermittent Claudication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Optical Coherence Tomography assessmentDiagnostic test
assessment of the number of infiltrating macrophages
| Study group | Role | What they receive |
|---|---|---|
| Stable coronary artery disease | Other | Not described Receives: Diagnostic Test: Optical Coherence Tomography assessment |
| Acute coronary syndrome | Other | Not described Receives: Diagnostic Test: Optical Coherence Tomography assessment |
| Intermittent claudication | Other | Not described Receives: Diagnostic Test: Optical Coherence Tomography assessment |
| Critical limb ischemia | Other | Not described Receives: Diagnostic Test: Optical Coherence Tomography assessment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to hospital discharge following peripheral angiography/coronary angiography
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 May 2026
- Study start18 Mar 2024
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stable Coronary Artery DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maria Cecilia Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07588295
- Sponsor's protocol ID
- LAST COP
- Status last verified
- Apr 2026
- First submitted
- 28 Apr 2026
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Local And Systemic Macrophage Activation in Coronary and Peripheral Artery Disease: the LAST-COP Study
- ClinicalTrials.gov ID
- NCT07588295
- Acronym / sponsor ID
- LAST COP
- Conditions
- Stable Coronary Artery Disease, Acute Coronary Syndromes, Critical Limb Ischemia, Intermittent Claudication
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Maria Cecilia HospitalUniversity, hospital or other
- Study start
- 18 Mar 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 14 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (8 listed)
- Severe renal dysfunction
- Severe valve disease
- Advanced heart failure
- Advanced liver disease
- Chronic inflammatory or autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Optical Coherence Tomography assessmentassessment of the number of infiltrating macrophages | Diagnostic test | Acute coronary syndrome, Critical limb ischemia, Intermittent claudication, Stable coronary artery disease |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Optical Coherence Tomography assessment in people with Stable Coronary Artery Disease and Acute Coronary Syndromes, run by Maria Cecilia Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Roberto Nerla, MD, PhD (+390545217032, robertonerla83@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
presence of macrophages and their activation within coronary and peripheral atherosclerotic lesions (time frame: From enrollment to hospital discharge following peripheral angiography/coronary angiography). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2026.