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

NCT03391908 | Completed DMC

• 1 other identifier: CM0116-PLI-1
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Coronary Stenosis; Acute Coronary Syndrome; Acute Myocardial Infarction; Atheromatous Plaques; Atherosclerosis; Unstable Angina; Non-ST Elevation Myocardial Infarction

Keywords

vulnerable plaque, ACS, NSTEMI, vulnerable patient

Outcome Measures

Primary Outcomes (1)

• 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.

  2 years

Secondary Outcomes (3)

• Revascularization rate

  2 years

• Rate of progression of the vulnerability degree of the coronary plaques

  1 year

• MACE rates (Major Adverse Cardiovascular Events)

  2 years

Study Arms (2)

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

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

Interventions

cardiac imaging tests DIAGNOSTIC_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.

MP - SG 01; MP - SG 02

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardio Med Medical Center: lead

Study Sites (1)

Cardio Med SRL

Târgu Mureş, Mureș County, 540136, Romania

Location

Related Publications (3)

• 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.

  PMID: 24463925 RESULT

• Benedek 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.

  PMID: 23333164 RESULT

• Benedek 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.

  PMID: 24126180 RESULT

Biospecimen

Retention: SAMPLES WITH DNA

Blood samples will be collected for determination of miRNA fractions associated with coronary plaque vulnerability

MeSH Terms

Conditions

Coronary Stenosis; Acute Coronary Syndrome; Plaque, Atherosclerotic; Atherosclerosis; Angina, Unstable; Non-ST Elevated Myocardial Infarction

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Arteriosclerosis; Arterial Occlusive Diseases; Angina Pectoris; Chest Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Myocardial Infarction; Infarction; Ischemia; Pathologic Processes; Necrosis

Study Officials

• Theodora Benedek, MD,Prof

  University of Medicine and Pharmacy of Tirgu Mures, CardioMed Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 31, 2017
• First Posted: January 5, 2018
• Study Start: April 1, 2018
• Primary Completion: September 30, 2020
• Study Completion: January 31, 2021
• Last Updated: August 2, 2022

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will become available immediately after completion of the enrolment and will remain available for at least 5 years

Locations

RO (1)