Acute Coronary SyndromePRECISIONNCT05727982
Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine
An observational study of Acute Coronary Syndrome and Chronic Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites in Italy.
Trial summary
To further improve the outcome of ACS it is strongly needed to identify new therapeutic targets. This is possible only by improving our knowledge of the multiple molecular mechanisms leading to coronary instability through several pathways. Read more about this study
- Who is it for?
- Ages 45 to 80 years
- Conditions the study is for
- Acute Coronary Syndrome, Chronic Coronary Syndrome
- What is being tested?
- Venous blood samples, Biological samples analysis, Cardiology visit.
- How many people
- 400 participants
- Where
- 2 sitesItaly
- Study dates
- 13 Sep 2019to 13 Sep 2024
- How long will I take part?
- 3 Years
- 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 45 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 1. Patients with plaque rupture and inflammation; 2. Patients with plaque rupture without inflammation; 3. Patients with intact fibrous plaque with evidence of thrombus (plaque erosion); 4. Patients with a smooth plaque.
Who may be able to join
- Men and post-menopause women of age 45-80 years; ability to understand and sign the informed consent;
- For NSTEMI and SA patients inclusion criteria will include evidence of obstructive atherosclerosis (> 70% stenosis) at invasive coronary angiography;
Who cannot join
- Evidence of inflammatory or infectious diseases, malignancies, immunological or haematological disorders;
- Ejection fraction less than 40%;
- Treatment with anti-inflammatory drugs other than low-dose aspirin, and with antibiotic therapies until 1 month before the enrollment.
Trial locations and contacts
2 sites in 1 country.
Italy2 sites, 1 recruiting
- Active, not recruiting
Fondazione Policlinico Gemelli
Roma, 00168
- Recruiting
Fondazione Policlinico Gemelli
Roma, 00168
Giovanna GL Liuzzo, +39 06/30154187, giovanna.liuzzo@policlinicogemelli.it
About this study
Official title: Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine (PRECISION Study)
To further improve the outcome of ACS it is strongly needed to identify new therapeutic targets. This is possible only by improving our knowledge of the multiple molecular mechanisms leading to coronary instability through several pathways. The goal of this project is to define the molecular mechanisms responsible for the four different presentations of ACS, to identify biomarkers for their noninvasive identification and potential new therapeutic targets, thus promoting precision medicine.
Read the detailed description
This is a multicenter prospective observational study, involving 5 Research Units (RU), the enrollment-phase will take 18 months (month 6 to 24). This is an explorative project that will prospectively enroll: 1) Consecutive patients with an admission diagnosis of ACS with Non ST elevation myocardial infarction (NSTEMI) confirmed at coronary angiography, undergoing OCT evaluation of the culprit coronary plaque before stent implantation for clinical reasons and with a clearly identifiable feature of the culprit plaques according to current European guidelines. ECG changes may include transient ST- segment elevation, persistent or transient ST-segment depression, T-wave inversion, flat T waves or pseudo- normalization of T waves or the ECG may be normal. Taking into account our previous studies, the investigators estimated that between 30-35% of NSTEMI patients will undergo OCT evaluation; 2) Consecutive patients with symptoms of Stable Angina (SA) lasting >12 months, angiographically confirmed coronary artery disease, without any episode suggestive of previous acute event, and no overt ischemic episodes during the last 48 hours, according to current European guidelines. Myocardial ischemia was documented by afunctional test (ie, exercise treadmill testing and/or myocardial perfusion imaging). Patients showing Q waves on 12-lead electrocardiogram and/or abnormal echocardiogram (ie, left ventricular ejection fraction <40% and/or wall motion abnormalities) were excluded. NSTEMI (within 12 hours of symptom onset) and SA patients will be enrolled at the time of their admission to the Coronary Care Unit and to the SubIntensive Cardiac Care Unit, of wich Prof. Giovanna Liuzzo (project PI) is the supervising physician; 3) In the same period, consecutive Mitral Valve Disease patients (MVD) with angiographically normal coronary arteries undergoing surgery for mitral valve regurgitation, age and sex matched 1:3 with NSTEMI patients, will be enrolled as control group. MVD patients will be enrolled at Cardiosurgery Operative Unit, lead by Professor Massimo Massetti.
Our RU1 will enroll:
- 150 consecutive patients with an admission diagnosis of NSTEMI.
- 50 consecutive patients with a diagnosis of SA.
- 50 consecutive MVD.
- Conditions
- Acute Coronary Syndrome, Chronic Coronary Syndrome
- Being tested
- Venous blood samples, Biological samples analysis, Cardiology visit.
- Keywords
- Atherosclerotic plaque, Optical Coherence Tomography
- Medical subject headings
- Acute Coronary Syndrome, Plaque, Atherosclerotic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Venous blood samples, Biological samples analysis, Cardiology visit.Diagnostic test
These interventions are important to study all patients recruited
| Study group | Role | What they receive |
|---|---|---|
| NSTEMI patients | Patients no ST-segment elevation myocardial infarction (NSTEMI) Receives: Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit. | |
| SA patients | Patients with Stable Angina (SA) diagnosis Receives: Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit. | |
| MVD patients | Patients with consecutive Mitral Valve Disease patients (MVD) Receives: Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identify homogeneous subsets of ACS patients at OCT interrogation of the culprit plaque
Using Optical Coherence Tomography
Measured: 2 week
Secondary outcomes (2)
Assess the role of shear stress in coronary instability
On OCT-based reconstruction of coronary lesions and fluid dynamics studies;
Measured: 1 year
Establish the most efficient and cost-effective biomarker panel
Establish the most efficient and cost-effective biomarker panel for the identification of homogeneous ACS patient subsets, this approach is relevant especially in centers where OCT is not available and unravel specific mechanisms and players of coronary instability and to identify molecular therapeutic targets, taking advantage of newomics technologies.
Measured: 1 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2023
- Study start13 Sep 2019
- Primary completion5 Sep 2023 (estimated)
- Study completion13 Sep 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Fondazione Policlinico Universitario Agostino Gemelli IRCCSThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 400 participants (estimated)
- Target duration
- 3 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Liuzzo Giovanna, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05727982
- Sponsor's protocol ID
- 2747
- Acronym
- PRECISION
- Status last verified
- Feb 2023
- First submitted
- 2 Feb 2023
- Last updated
- 14 Feb 2023
- 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 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Molecular Mechanisms of Coronary Instability in Homogeneous Subsets of Patients With Acute Coronary Syndromes for the Implementation of Precision Medicine (PRECISION Study)
- ClinicalTrials.gov ID
- NCT05727982
- Acronym / sponsor ID
- PRECISION / 2747
- Conditions
- Acute Coronary Syndrome, Chronic Coronary Syndrome
- Keywords
- Atherosclerotic plaque, Optical Coherence Tomography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 13 Sep 2019 (actual)
- Primary completion
- 5 Sep 2023 (estimated)
- Study completion
- 13 Sep 2024 (estimated)
- First posted
- 14 Feb 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.
To further improve the outcome of ACS it is strongly needed to identify new therapeutic targets. This is possible only by improving our knowledge of the multiple molecular mechanisms leading to coronary instability through several pathways. The goal of this project is to define the molecular mechanisms responsible for the four different presentations of ACS, to identify biomarkers for their noninvasive identification and potential new therapeutic targets, thus promoting precision medicine.
Detailed description
This is a multicenter prospective observational study, involving 5 Research Units (RU), the enrollment-phase will take 18 months (month 6 to 24). This is an explorative project that will prospectively enroll: 1) Consecutive patients with an admission diagnosis of ACS with Non ST elevation myocardial infarction (NSTEMI) confirmed at coronary angiography, undergoing OCT evaluation of the culprit coronary plaque before stent implantation for clinical reasons and with a clearly identifiable feature of the culprit plaques according to current European guidelines. ECG changes may include transient ST- segment elevation, persistent or transient ST-segment depression, T-wave inversion, flat T waves or pseudo- normalization of T waves or the ECG may be normal. Taking into account our previous studies, the investigators estimated that between 30-35% of NSTEMI patients will undergo OCT evaluation; 2) Consecutive patients with symptoms of Stable Angina (SA) lasting >12 months, angiographically confirmed coronary artery disease, without any episode suggestive of previous acute event, and no overt ischemic episodes during the last 48 hours, according to current European guidelines. Myocardial ischemia was documented by afunctional test (ie, exercise treadmill testing and/or myocardial perfusion imaging). Patients showing Q waves on 12-lead electrocardiogram and/or abnormal echocardiogram (ie, left ventricular ejection fraction <40% and/or wall motion abnormalities) were excluded. NSTEMI (within 12 hours of symptom onset) and SA patients will be enrolled at the time of their admission to the Coronary Care Unit and to the SubIntensive Cardiac Care Unit, of wich Prof. Giovanna Liuzzo (project PI) is the supervising physician; 3) In the same period, consecutive Mitral Valve Disease patients (MVD) with angiographically normal coronary arteries undergoing surgery for mitral valve regurgitation, age and sex matched 1:3 with NSTEMI patients, will be enrolled as control group. MVD patients will be enrolled at Cardiosurgery Operative Unit, lead by Professor Massimo Massetti.
Our RU1 will enroll:
- 150 consecutive patients with an admission diagnosis of NSTEMI.
- 50 consecutive patients with a diagnosis of SA.
- 50 consecutive MVD.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 3 Years
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NSTEMI patients | – | Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit.Patients no ST-segment elevation myocardial infarction (NSTEMI) |
| SA patients | – | Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit.Patients with Stable Angina (SA) diagnosis |
| MVD patients | – | Diagnostic Test: Venous blood samples, Biological samples analysis, Cardiology visit.Patients with consecutive Mitral Valve Disease patients (MVD) |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 1. Patients with plaque rupture and inflammation; 2. Patients with plaque rupture without inflammation; 3. Patients with intact fibrous plaque with evidence of thrombus (plaque erosion); 4. Patients with a smooth plaque.
Key inclusion criteria (2 listed)
- Men and post-menopause women of age 45-80 years; ability to understand and sign the informed consent;
- For NSTEMI and SA patients inclusion criteria will include evidence of obstructive atherosclerosis (> 70% stenosis) at invasive coronary angiography;
Key exclusion criteria (3 listed)
- Evidence of inflammatory or infectious diseases, malignancies, immunological or haematological disorders;
- Ejection fraction less than 40%;
- Treatment with anti-inflammatory drugs other than low-dose aspirin, and with antibiotic therapies until 1 month before the enrollment.
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 |
|---|---|---|
| Venous blood samples, Biological samples analysis, Cardiology visit.These interventions are important to study all patients recruited | Diagnostic test | MVD patients, NSTEMI patients, SA patients |
Primary outcome
Identify homogeneous subsets of ACS patients at OCT interrogation of the culprit plaque
Time frame: 2 week
Using Optical Coherence Tomography
2 secondary outcomes
Assess the role of shear stress in coronary instability
Time frame: 1 year
Establish the most efficient and cost-effective biomarker panel
Time frame: 1 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- 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. This study is not recruiting at the moment.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome and Chronic Coronary Syndrome, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 2 sites 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 2 inclusion and 3 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 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Giovanna GL Liuzzo (06/30154187, giovanna.liuzzo@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identify homogeneous subsets of ACS patients at OCT interrogation of the culprit plaque (time frame: 2 week). 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 Feb 2023.