Coronary SyndromePLAQUENCT06103357
Identification of Biomarkers in Subjects With Coronary Syndrome (PLAQUE Study)
An observational study of Coronary Syndrome, run by Istituto Nazionale di Ricovero e Cura per Anziani at 1 site in Italy.
Trial summary
The study will to test the levels of innovative biomarkers, such as miRNAs, in the blood of subjects underwent to angioplasty procedure according to standard clinical practice. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Syndrome
- What is being tested?
- blood sample collection
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- 6 Mar 2023to 30 Apr 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Patients affected by Acute Coronary Syndrome (ACS) and Chronic Coronary Syndrome (CCS) with clinical indications for coronary angiography, demonstrating the presence of significant coronary artery disease.
Who may be able to join
- Clinical indication for the PCI procedure according to the latest ESC (European Society of Cardiology) Guidelines
- Coronary stenosis treated with angioplasty must be located in the proximal segments of the three main vessels: IVA, CX and CD
- The vessels must have a diameter of their mid-distal section ≥ 3 mm
- Patients with NSTEMI ACS and clinical indication with favorable anatomy for coronary angioplasty, also called percutaneous coronary intervention (PCI), (for the ACS group)
- Patients with clinically incipient SCC with stable angina (or significant anginal equivalents) and clinical indication with favorable anatomy for PCI (for the SCC group)
Who cannot join
- Contraindications to anticoagulant/antiplatelet therapy
- Extensive calcifications and/or tortuosity of the major epicardial segments
- Evidence of thrombotic occupation
- Patients with hemodynamic instability
- Patients with EF (ejection fraction) < 35%
- Patients with severe chronic renal failure (e-GFR < 30 mL/min)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS INRCA Hospital
Ancona
Olga Protic, PhD, o.protic@inrca.it
Gabriele Gabrielli, MD
About this study
Official title: Identification of Innovative Circulating and Cellular Biomarkers in Subjects With Acute and Chronic Coronary Syndrome (PLAQUE Study)
The study will to test the levels of innovative biomarkers, such as miRNAs, in the blood of subjects underwent to angioplasty procedure according to standard clinical practice.
Read the detailed description
Twenty patients with acute coronary syndrome from non-ST-segment elevation myocardial infarction or with chronic coronary syndrome with clinical indication and favorable anatomy for coronary angioplasty will be enrolled. The angioplasty procedure will be performed according to standard clinical practice. Before and after angioplasty, blood samples will be taken upstream and downstream of the coronary lesion, arterial sampling will be performed at the level of the aortic root, and peripheral venous blood will be collected. MicroRNA expression will be analyzed in serum by next-generation sequencing (miRNome). Quantitative analysis of pro- and anti-inflammatory molecules such as IL-6 and the soluble form of IL-33 receptor (sST2) will be performed on various blood samples.
- Conditions
- Coronary Syndrome
- Being tested
- blood sample collection
- Keywords
- Acute Coronary Syndrome, Chronic Coronary Syndrome, microRNAs, soluble ST2, interleukin-6
- Medical subject headings
- Angina, Unstable, Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood sample collectionOther
Before and after angioplasty, blood samples upstream and downstream of the coronary lesion will be taken, arterial sampling at the aortic root level will be performed, and peripheral venous blood will be collected.
| Study group | Role | What they receive |
|---|---|---|
| subjects with clinical indication for coronary angioplasty | Twenty subjects with acute or chronic coronary syndrome that will be underwent to angioplasty procedure according to standard clinical practice. Receives: Other: blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNome analysis
The Next Generation Sequencing (NGS) techniques will be used to identify miRNome picture as potential biomarkers for acute and chronic coronary syndrome.
Measured: baseline
Secondary outcomes (1)
Identification of biomarkers of inflammation
Interleukin-6 and soluble ST2 levels will be assessed in plasma samples.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start6 Mar 2023
- Primary completion30 Apr 2024 (estimated)
- Study completion30 Apr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Coronary SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per Anziani
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Health, Italy
- Responsible party
- Sponsor
- Investigators
- Roberto Antonicelli, MD, Study director, IRCCS INRCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103357
- Sponsor's protocol ID
- INRCA_009_2023
- Acronym
- PLAQUE
- Status last verified
- Oct 2023
- First submitted
- 23 Oct 2023
- Last updated
- 5 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Protic O, Bonfigli AR, Olivieri F, Lamedica AM, Gabrielli G, Antonicelli R. miRNome profile in blood samples upstream and downstream of the coronary lesion and arterial aortic root before and after angioplasty in subjects with chronic and acute coronary syndrome: A pilot observational study protocol (Plaque study). PLoS One. 2025 Jun 13;20(6):e0324467. doi: 10.1371/journal.pone.0324467. eCollection 2025.
PubMed 40512691
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Innovative Circulating and Cellular Biomarkers in Subjects With Acute and Chronic Coronary Syndrome (PLAQUE Study)
- ClinicalTrials.gov ID
- NCT06103357
- Acronym / sponsor ID
- PLAQUE / INRCA_009_2023
- Conditions
- Coronary Syndrome
- Keywords
- Acute Coronary Syndrome, Chronic Coronary Syndrome, microRNAs, soluble ST2, interleukin-6
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Istituto Nazionale di Ricovero e Cura per AnzianiUniversity, hospital or other
- Collaborators
- Ministry of Health, Italy
- Study start
- 6 Mar 2023 (actual)
- Primary completion
- 30 Apr 2024 (estimated)
- Study completion
- 30 Apr 2024 (estimated)
- First posted
- 26 Oct 2023 (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.
The study will to test the levels of innovative biomarkers, such as miRNAs, in the blood of subjects underwent to angioplasty procedure according to standard clinical practice.
Detailed description
Twenty patients with acute coronary syndrome from non-ST-segment elevation myocardial infarction or with chronic coronary syndrome with clinical indication and favorable anatomy for coronary angioplasty will be enrolled. The angioplasty procedure will be performed according to standard clinical practice. Before and after angioplasty, blood samples will be taken upstream and downstream of the coronary lesion, arterial sampling will be performed at the level of the aortic root, and peripheral venous blood will be collected. MicroRNA expression will be analyzed in serum by next-generation sequencing (miRNome). Quantitative analysis of pro- and anti-inflammatory molecules such as IL-6 and the soluble form of IL-33 receptor (sST2) will be performed on various blood samples.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| subjects with clinical indication for coronary angioplasty | – | Other: blood sample collectionTwenty subjects with acute or chronic coronary syndrome that will be underwent to angioplasty procedure according to standard clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients affected by Acute Coronary Syndrome (ACS) and Chronic Coronary Syndrome (CCS) with clinical indications for coronary angiography, demonstrating the presence of significant coronary artery disease.
Key inclusion criteria (5 listed)
- Clinical indication for the PCI procedure according to the latest ESC (European Society of Cardiology) Guidelines
- Coronary stenosis treated with angioplasty must be located in the proximal segments of the three main vessels: IVA, CX and CD
- The vessels must have a diameter of their mid-distal section ≥ 3 mm
- Patients with NSTEMI ACS and clinical indication with favorable anatomy for coronary angioplasty, also called percutaneous coronary intervention (PCI), (for the ACS group)
- Patients with clinically incipient SCC with stable angina (or significant anginal equivalents) and clinical indication with favorable anatomy for PCI (for the SCC group)
Key exclusion criteria (6 listed)
- Contraindications to anticoagulant/antiplatelet therapy
- Extensive calcifications and/or tortuosity of the major epicardial segments
- Evidence of thrombotic occupation
- Patients with hemodynamic instability
- Patients with EF (ejection fraction) < 35%
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 |
|---|---|---|
| blood sample collectionBefore and after angioplasty, blood samples upstream and downstream of the coronary lesion will be taken, arterial sampling at the aortic root level will be performed, and peripheral venous blood will be collected. | Other | subjects with clinical indication for coronary angioplasty |
Primary outcome
miRNome analysis
Time frame: baseline
The Next Generation Sequencing (NGS) techniques will be used to identify miRNome picture as potential biomarkers for acute and chronic coronary syndrome.
1 secondary outcome
Identification of biomarkers of inflammation
Time frame: baseline
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Derived from this study: PubMed 40512691Protic O, Bonfigli AR, Olivieri F, Lamedica AM, Gabrielli G, Antonicelli R. miRNome profile in blood samples upstream and downstream of the coronary lesion and arterial aortic root before and after angioplasty in subjects with chronic and acute coronary syndrome: A pilot observational study protocol (Plaque study). PLoS One. 2025 Jun 13;20(6):e0324467. doi: 10.1371/journal.pone.0324467. eCollection 2025.
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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. This study is not recruiting at the moment.
Roberto Antonicelli, MD study director
IRCCS INRCA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coronary Syndrome, run by Istituto Nazionale di Ricovero e Cura per Anziani 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 5 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 5 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anna Rita Bonfigli, PhD (0718003719, a.bonfigli@inrca.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNome analysis (time frame: baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06103357, which also lists 1 linked publication.
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 5 Mar 2024.