Acute Coronary Syndrome Clinical Trial
— MultiPlaqueOfficial 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
NCT number | NCT03391908 |
Other study ID # | CM0116-PLI-1 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | April 1, 2018 |
Est. completion date | January 31, 2021 |
Verified date | July 2021 |
Source | Cardio Med Medical Center |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 100 |
Est. completion date | January 31, 2021 |
Est. primary completion date | September 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Romania | Cardio Med SRL | Târgu-Mures | Mures |
Lead Sponsor | Collaborator |
---|---|
Cardio Med Medical Center |
Romania,
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. Epub 2013 Oct 12. — View Citation
Benedek T, Gyöngyösi 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. — View Citation
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. Epub 2014 Jan 27. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | 2 years | |
Secondary | 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 | 1 year | |
Secondary | 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 | 2 years |
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