Multiomics and Imaging-based Assessment of Vulnerable Coronary Plaques in Acute Coronary Syndromes (MultiPlaque)

July 30, 2022 updated by: Cardio Med Medical Center

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Romania
    • Mures
      • Târgu-Mureş, Mures, Romania, 540136
        • Cardio Med SRL

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

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.

Exclusion Criteria: (for both substudies)

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Diagnostic test: cardiac imaging tests
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.
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.
Diagnostic test: cardiac imaging tests
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
2 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Revascularization rate
Time Frame: 2 years
The need for revascularization of the culprit lesion and of the non-culprit lesions will be assessed during the 2-year follow-up
2 years
Rate of progression of the vulnerability degree of the coronary plaques
Time Frame: 1 year
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
1 year
MACE rates (Major Adverse Cardiovascular Events)
Time Frame: 2 years
Major adverse cardiac events represented by cardiac death, all-cause death, rehospitalization rate, target vessel revascularization and re-infarction rate
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cardio Med Medical Center

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Theodora Benedek, MD,Prof, University of Medicine and Pharmacy of Tirgu Mures, CardioMed Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 30, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 31, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 31, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 31, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 5, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 2, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 30, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CM0116-PLI-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

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

IPD Sharing Time Frame

Data will become available immediately after completion of the enrolment and will remain available for at least 5 years

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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