Coronary StenosisMultiPlaqueNCT03391908
Multiomics and Imaging-based Assessment of Vulnerable Coronary Plaques in Acute Coronary Syndromes
An observational study of Coronary Stenosis and Acute Coronary Syndrome, run by Cardio Med Medical Center at 1 site in Romania.
Trial summary
The aim of Multiplaque clinical study is to assess the vulnerability degree of the atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics analysis, associated with invasive and non-invasive data. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Coronary Stenosis, Acute Coronary Syndrome, Acute Myocardial Infarction
- What is being tested?
- cardiac imaging tests
- How many people
- 100 participants
- Where
- 1 siteRomania
- Study dates
- 1 Apr 2018to 31 Jan 2021
- 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
- No healthy volunteers
- Adult, Older adult
Study population: The study lot will be comprised by 100 patients out of which: * lot 1 (substudy 1) - 50 patients with unstable angina type acute coronary syndrome * lot 2 (substduy 2) - 50 patients with acute myocardial infarction (STEMI or NSTEMI) that occurred 30 days before randomization.
Who may be able to join
- Substudy 1:
- Patients aged at least 18 years
- Patients who have signed the informed consent
- Unstable angina type acute coronary syndrome with maximum 48h before presentation, defined as the presence of typical angina pain, with duration of more than 5 minute, accompanied by ECG changes.
- Substudy 2:
- Patients aged at least 18 years
- Patients who have signed the informed consent
- Acute myocardial infarction (STEMI or NSTEMI) defined as typical changes on the ECG (ST elevation of minimum 1 mm in at least 2 consecutive leads - STEMI; ST-T changes for NSTEMI) accompanied by increased levels of cardiac troponin I or T, or CK-MB of more than 2x the normal reference value of the laboratory.
Who cannot join
- Known sensibility for the contrast agents
- Women at reproductive age who does not use contraceptive methods
- Pregnant women
- Any malignancy within the last 5 years
- Acute or chronic renal failure
- Any disease or comorbidity that reduces the life expectancy under 2 years
- Non-compliant patients who, in the opinion of the investigators, will not undergo the follow-up process
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Monocentric Clinical Study for Multiomics and Imaging-based Assessment of the Vulnerable Coronary Plaques and Associated Risk in Patients Who Presented an Acute Coronary Syndrome
The aim of Multiplaque clinical study is to assess the vulnerability degree of the atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics analysis, associated with invasive and non-invasive data. In this study, a multi-parametric model for risk prediction will be developed, for evaluation of the risk that is associated with the vulnerable coronary plaques in patients that have suffered an acute coronary syndrome.
In the study, evaluation of the imaging characteristics of these coronary plaques will be performed with the use of CT, OCT, IVUS and invasive angiography. We will study the correlation between plaque evolution and (1) the degree of vulnerability at baseline, (2) multiomics profile of the patients and (3) clinical evolution during follow-up.
Also, new techniques for evaluation of the functional significance of coronary stenoses will be studied and validated, such as calculation of the fractional flow reserve or determination of shear stress in areas that are localized within the near vicinity of the vulnerable coronary plaques.
Read the detailed description
This is a prospective cohort monocentric study.
The primary objective of this study is to research the vulnerability degree of ateromatous plaques before and after a myocardial infarction, based on multiomics data, invasive and non-invasive imaging data, in order to characterize the vulnerable coronary plaque and the vulnerable patient, in patients who have suffered an acute coronary syndrome (unstable angina or acute myocardial infarction).
The secondary objectives of the study are:
- Evaluation of factors associated with the risk for reinfarction in patients with vulnerable plaques, according to their imaging characteristics of vulnerability.
- Evaluation of predictive factors for reinfarction in patients with vulnerable plaques, according to the multiomics profile of the patient.
- Determination of the rate of adverse events and MACE rates (Major Adverse Cardiac Events) according to the vulnerability degree of the coronary plaque at the index moment.
- Evaluation of the efficiency of new methodologies for assessing vulnerable plaques: coronary shear stress determination, trans-stenotic contrast gradient, quantification of coronary plaque components through CT, OCT and IVUS.
- Evaluation of the efficiency of non-invasive methodologies for assessment of the hemodynamic significance of coronary stenoses.
Study population: The study lot will be comprised by 100 patients out of which:
- lot 1 (substudy 1) - 50 patients with unstable angina type acute coronary syndrome
- lot 2 (substudy 2) - 50 patients with acute myocardial infarction (STEMI or NSTEMI) that occurred 30 days before randomization.
Study design and procedures:
Substudy 1: Research of vulnerable plaques in patients with ACS - Unstable angina
Baseline- Day 1: The following procedures will be performed at baseline:
- Personal data recording (age, gender, address, contact);
- anamnesis, cardiovascular risk assessment, comorbidities;
- Physical examination
- Laboratory analysis (biochemistry Cell blood count, troponin assay, hsCRP, matrix metalloproteinases, miRNAs, multiomic analysis)
- ECG
- Echocardiography (LVEF, chamber volumes and diameters, transmitral valvular flow, pulmonary artery pressure, 3D analysis of the regional kinetics with speckle tracking and tissue Doppler, evaluation of valvular regurgitation)
- Myocardial perfusion echocardiography
- Cardiac computed tomography
- Perfusion CT
- Coronary Angiography +/- stent implantation for the culprit lesion
- Optical coherence tomography
- Intravascular ultrasound
Follow-up:
- Month 1 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 3 - telephone follow-up
- Month 6 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 12 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 15 - telephone follow-up
- Month 18 - telephone follow-up
- Month 24 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation, Cardiac Computed Tomography, Perfusion CT
Substudy 2: Research of remaining vulnerable plaques in patients who have suffered an acute myocardial infarction (STEMI or NSTEMI), with maximum 30 days before the enrollment. The index event is considered to be the acute myocardial infarction.
Baseline - day 1: The following procedures will be performed at baseline:
- Personal data recording (age, gender, address, contact);
- Anamnesis, cardiovascular risk assessment, comorbidities;
- Physical examination;
- Laboratory analysis (biochemistry, Cell blood count, troponin assay, hsCRP, matrix metalloproteinases, miRNAs, multiomic analysis)
- ECG
- Echocardiography (LVEF, chamber volumes and diameters, transmitral valvular flow, pulmonary artery pressure, 3D analysis of the regional kinetics with speckle tracking and tissue Doppler, evaluation of valvular regurgitation)
- Myocardial perfusion echocardiography
- Cardiac computed tomography
- Perfusion CT
- Coronary Angiography +/- stent implantation for the culprit lesion
- Optical coherence tomography
Follow-up:
- Month 1 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 3 - telephone follow-up
- Month 6 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 12 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 15 - telephone follow-up
- Month 18 - telephone follow-up
- Month 24 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation, Cardiac Computed Tomography, Perfusion CT
- Conditions
- Coronary Stenosis, Acute Coronary Syndrome, Acute Myocardial Infarction, Atheromatous Plaques, Atherosclerosis, Unstable Angina
- Being tested
- cardiac imaging tests
- Keywords
- vulnerable plaque, ACS, NSTEMI, vulnerable patient
- Medical subject headings
- Coronary Stenosis, Acute Coronary Syndrome, Plaque, Atherosclerotic, Atherosclerosis, Angina, Unstable, Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac imaging testsDiagnostic test
Patients will undergo non-invasive Cardiac Computed Tomography for assessment of coronary plaques and myocardial perfusion, and invasive intracoronary imaging tests (coronary angiography, Intravascular ultrasound, optical coherence tomography and FFR). If imaging will reveal existence of a significant coronary plaque, a percutaneous coronary intervention (PCI - stenting) will be performed.
| Study group | Role | What they receive |
|---|---|---|
| MP - SG 01 | Patients with unstable angina type acute coronary syndrome: patients aged at least 18 years, who have signed the informed consent, and present an unstable angina-type acute coronary syndrome with maximum 48h before presentation, defined as the presence of typical angina pain, with duration of more than 5 minute, accompanied by ECG changes. Receives: Diagnostic Test: cardiac imaging tests | |
| MP - SG 02 | Patients with acute myocardial infarction (STEMI or NSTEMI) that occurred 30 days before randomization: patients aged at least 18 years, who have signed the informed consent, and present with acute myocardial infarction (STEMI or NSTEMI) defined as typical changes on the ECG (ST elevation of minimum 1 mm in at least 2 consecutive leads - STEMI; ST-T changes for NSTEMI) accompanied by increased levels of cardiac troponin I or T, or CK-MB of more than 2x the normal reference value of the laboratory. Receives: Diagnostic Test: cardiac imaging tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of major clinical endpoints - acute myocardial infarction - occuring in the follow-up period
The rate of infarction (in the group of unstable angina) or re-infarction (in the group with already established myocardial infarction) will be assessed during the 2-year follow-up and correlated with the degree of plaque vulnerability as determined by imaging tests.
Measured: 2 years
Secondary outcomes (3)
Revascularization rate
The need for revascularization of the culprit lesion and of the non-culprit lesions will be assessed during the 2-year follow-up
Measured: 2 years
Rate of progression of the vulnerability degree of the coronary plaques
The vulnerability degree of each coronary lesion will be assessed by Cardiac CT at base-line and at 1-year follow-up, and the progression/regression of the vulnerability degree will be calculated
Measured: 1 year
MACE rates (Major Adverse Cardiovascular Events)
Major adverse cardiac events represented by cardiac death, all-cause death, rehospitalization rate, target vessel revascularization and re-infarction rate
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2018
- Study start1 Apr 2018
- Primary completion30 Sep 2020
- Study completion31 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Coronary StenosisStudies 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cardio Med Medical Center
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Theodora Benedek, MD,Prof, Principal investigator, University of Medicine and Pharmacy of Tirgu Mures, CardioMed Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03391908
- Sponsor's protocol ID
- CM0116-PLI-1
- Acronym
- MultiPlaque
- Status last verified
- Jul 2021
- First submitted
- 31 Dec 2017
- Last updated
- 2 Aug 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD will be made available to other researchers from the same research group and to other collaborating groups and can be used for further statistical sub-analysis
Publications
Benedek T, Jako B, Benedek I. Plaque quantification by coronary CT and intravascular ultrasound identifies a low CT density core as a marker of plaque instability in acute coronary syndromes. Int Heart J. 2014;55(1):22-8. doi: 10.1536/ihj.13-213. Epub 2014 Jan 27.
PubMed 24463925Benedek T, Gyongyosi M, Benedek I. Multislice computed tomographic coronary angiography for quantitative assessment of culprit lesions in acute coronary syndromes. Can J Cardiol. 2013 Mar;29(3):364-71. doi: 10.1016/j.cjca.2012.11.004. Epub 2013 Jan 17.
PubMed 23333164Benedek I, Bucur O, Benedek T. Intracoronary infusion of mononuclear bone marrow-derived stem cells is associated with a lower plaque burden after four years. J Atheroscler Thromb. 2014;21(3):217-29. doi: 10.5551/jat.19745. Epub 2013 Oct 12.
PubMed 24126180
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Monocentric Clinical Study for Multiomics and Imaging-based Assessment of the Vulnerable Coronary Plaques and Associated Risk in Patients Who Presented an Acute Coronary Syndrome
- ClinicalTrials.gov ID
- NCT03391908
- Acronym / sponsor ID
- MultiPlaque / CM0116-PLI-1
- Conditions
- Coronary Stenosis, Acute Coronary Syndrome, Acute Myocardial Infarction, Atheromatous Plaques, Atherosclerosis, Unstable Angina
- Keywords
- vulnerable plaque, ACS, NSTEMI, vulnerable patient
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Cardio Med Medical CenterIndustry (pharma, biotech, devices)
- Study start
- 1 Apr 2018 (actual)
- Primary completion
- 30 Sep 2020 (actual)
- Study completion
- 31 Jan 2021 (actual)
- First posted
- 5 Jan 2018 (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 aim of Multiplaque clinical study is to assess the vulnerability degree of the atheromatous plaques, before and after a myocardial infarction (MI), based on multiomics analysis, associated with invasive and non-invasive data. In this study, a multi-parametric model for risk prediction will be developed, for evaluation of the risk that is associated with the vulnerable coronary plaques in patients that have suffered an acute coronary syndrome.
In the study, evaluation of the imaging characteristics of these coronary plaques will be performed with the use of CT, OCT, IVUS and invasive angiography. We will study the correlation between plaque evolution and (1) the degree of vulnerability at baseline, (2) multiomics profile of the patients and (3) clinical evolution during follow-up.
Also, new techniques for evaluation of the functional significance of coronary stenoses will be studied and validated, such as calculation of the fractional flow reserve or determination of shear stress in areas that are localized within the near vicinity of the vulnerable coronary plaques.
Detailed description
This is a prospective cohort monocentric study.
The primary objective of this study is to research the vulnerability degree of ateromatous plaques before and after a myocardial infarction, based on multiomics data, invasive and non-invasive imaging data, in order to characterize the vulnerable coronary plaque and the vulnerable patient, in patients who have suffered an acute coronary syndrome (unstable angina or acute myocardial infarction).
The secondary objectives of the study are:
- Evaluation of factors associated with the risk for reinfarction in patients with vulnerable plaques, according to their imaging characteristics of vulnerability.
- Evaluation of predictive factors for reinfarction in patients with vulnerable plaques, according to the multiomics profile of the patient.
- Determination of the rate of adverse events and MACE rates (Major Adverse Cardiac Events) according to the vulnerability degree of the coronary plaque at the index moment.
- Evaluation of the efficiency of new methodologies for assessing vulnerable plaques: coronary shear stress determination, trans-stenotic contrast gradient, quantification of coronary plaque components through CT, OCT and IVUS.
- Evaluation of the efficiency of non-invasive methodologies for assessment of the hemodynamic significance of coronary stenoses.
Study population: The study lot will be comprised by 100 patients out of which:
- lot 1 (substudy 1) - 50 patients with unstable angina type acute coronary syndrome
- lot 2 (substudy 2) - 50 patients with acute myocardial infarction (STEMI or NSTEMI) that occurred 30 days before randomization.
Study design and procedures:
Substudy 1: Research of vulnerable plaques in patients with ACS - Unstable angina
Baseline- Day 1: The following procedures will be performed at baseline:
- Personal data recording (age, gender, address, contact);
- anamnesis, cardiovascular risk assessment, comorbidities;
- Physical examination
- Laboratory analysis (biochemistry Cell blood count, troponin assay, hsCRP, matrix metalloproteinases, miRNAs, multiomic analysis)
- ECG
- Echocardiography (LVEF, chamber volumes and diameters, transmitral valvular flow, pulmonary artery pressure, 3D analysis of the regional kinetics with speckle tracking and tissue Doppler, evaluation of valvular regurgitation)
- Myocardial perfusion echocardiography
- Cardiac computed tomography
- Perfusion CT
- Coronary Angiography +/- stent implantation for the culprit lesion
- Optical coherence tomography
- Intravascular ultrasound
Follow-up:
- Month 1 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 3 - telephone follow-up
- Month 6 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 12 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 15 - telephone follow-up
- Month 18 - telephone follow-up
- Month 24 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation, Cardiac Computed Tomography, Perfusion CT
Substudy 2: Research of remaining vulnerable plaques in patients who have suffered an acute myocardial infarction (STEMI or NSTEMI), with maximum 30 days before the enrollment. The index event is considered to be the acute myocardial infarction.
Baseline - day 1: The following procedures will be performed at baseline:
- Personal data recording (age, gender, address, contact);
- Anamnesis, cardiovascular risk assessment, comorbidities;
- Physical examination;
- Laboratory analysis (biochemistry, Cell blood count, troponin assay, hsCRP, matrix metalloproteinases, miRNAs, multiomic analysis)
- ECG
- Echocardiography (LVEF, chamber volumes and diameters, transmitral valvular flow, pulmonary artery pressure, 3D analysis of the regional kinetics with speckle tracking and tissue Doppler, evaluation of valvular regurgitation)
- Myocardial perfusion echocardiography
- Cardiac computed tomography
- Perfusion CT
- Coronary Angiography +/- stent implantation for the culprit lesion
- Optical coherence tomography
Follow-up:
- Month 1 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 3 - telephone follow-up
- Month 6 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 12 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation
- Month 15 - telephone follow-up
- Month 18 - telephone follow-up
- Month 24 - anamnesis, physical examination, ECG, echocardiography, end-point evaluation, Cardiac Computed Tomography, Perfusion CT
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MP - SG 01 | – | Diagnostic Test: cardiac imaging testsPatients with unstable angina type acute coronary syndrome: patients aged at least 18 years, who have signed the informed consent, and present an unstable angina-type acute coronary syndrome with maximum 48h before presentation, defined as the presence of typical angina pain, with duration of more than 5 minute, accompanied by ECG changes. |
| MP - SG 02 | – | Diagnostic Test: cardiac imaging testsPatients with acute myocardial infarction (STEMI or NSTEMI) that occurred 30 days before randomization: patients aged at least 18 years, who have signed the informed consent, and present with acute myocardial infarction (STEMI or NSTEMI) defined as typical changes on the ECG (ST elevation of minimum 1 mm in at least 2 consecutive leads - STEMI; ST-T changes for NSTEMI) accompanied by increased levels of cardiac troponin I or T, or CK-MB of more than 2x the normal reference value of the laboratory. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study lot will be comprised by 100 patients out of which: * lot 1 (substudy 1) - 50 patients with unstable angina type acute coronary syndrome * lot 2 (substduy 2) - 50 patients with acute myocardial infarction (STEMI or NSTEMI) that occurred 30 days before randomization.
Key inclusion criteria (8 listed)
- Patients aged at least 18 years
- Patients who have signed the informed consent
- Unstable angina type acute coronary syndrome with maximum 48h before presentation, defined as the presence of typical angina pain, with duration of more than 5 minute, accompanied by ECG changes.
- Patients aged at least 18 years
- Patients who have signed the informed consent
Key exclusion criteria (7 listed)
- Known sensibility for the contrast agents
- Women at reproductive age who does not use contraceptive methods
- Pregnant women
- Any malignancy within the last 5 years
- Acute or chronic renal failure
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 |
|---|---|---|
| cardiac imaging testsPatients will undergo non-invasive Cardiac Computed Tomography for assessment of coronary plaques and myocardial perfusion, and invasive intracoronary imaging tests (coronary angiography, Intravascular ultrasound, optical coherence tomography and FFR). If imaging will reveal existence of a significant coronary plaque, a percutaneous coronary intervention (PCI - stenting) will be performed. | Diagnostic test | MP - SG 01, MP - SG 02 |
Primary outcome
rate of major clinical endpoints - acute myocardial infarction - occuring in the follow-up period
Time frame: 2 years
The rate of infarction (in the group of unstable angina) or re-infarction (in the group with already established myocardial infarction) will be assessed during the 2-year follow-up and correlated with the degree of plaque vulnerability as determined by imaging tests.
3 secondary outcomes
Revascularization rate
Time frame: 2 years
Rate of progression of the vulnerability degree of the coronary plaques
Time frame: 1 year
MACE rates (Major Adverse Cardiovascular Events)
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2022.
- Results publication: PubMed 24463925Benedek T, Jako B, Benedek I. Plaque quantification by coronary CT and intravascular ultrasound identifies a low CT density core as a marker of plaque instability in acute coronary syndromes. Int Heart J. 2014;55(1):22-8. doi: 10.1536/ihj.13-213. Epub 2014 Jan 27.
- Results publication: PubMed 23333164Benedek T, Gyongyosi M, Benedek I. Multislice computed tomographic coronary angiography for quantitative assessment of culprit lesions in acute coronary syndromes. Can J Cardiol. 2013 Mar;29(3):364-71. doi: 10.1016/j.cjca.2012.11.004. Epub 2013 Jan 17.
- Results publication: PubMed 24126180Benedek I, Bucur O, Benedek T. Intracoronary infusion of mononuclear bone marrow-derived stem cells is associated with a lower plaque burden after four years. J Atheroscler Thromb. 2014;21(3):217-29. doi: 10.5551/jat.19745. Epub 2013 Oct 12.
- Individual participant dataSharing planned: Yes. IPD will be made available to other researchers from the same research group and to other collaborating groups and can be used for further statistical sub-analysis
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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.
Theodora Benedek, MD,Prof principal investigator
University of Medicine and Pharmacy of Tirgu Mures, CardioMed Medical Center
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 Stenosis and Acute Coronary Syndrome, run by Cardio Med Medical Center at 1 site in Romania.
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 8 inclusion and 7 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: finished, as of the sponsor's last update on 2 Aug 2022. 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 Romania. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
rate of major clinical endpoints - acute myocardial infarction - occuring in the follow-up period (time frame: 2 years). 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 NCT03391908, which also lists 3 linked publications.
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 2 Aug 2022.