An observational study in Coronary Stenosis, Acute Coronary Syndrome and Acute Myocardial Infarction, sponsored by Cardio Med Medical Center. Completed at 1 site in Romania. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-02.
Sponsored by Cardio Med Medical Center · Observational
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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.
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:
Study population: The study lot will be comprised by 100 patients out of which:
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:
Follow-up:
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:
Follow-up:
326 studies on the registry are indexed under Coronary Stenosis; 57 are open to participants now.
This study's enrollment of 100 is below the median of 200 across 125 observational studies indexed under Coronary Stenosis.
Browse Coronary Stenosis studies →Cardio Med Medical Center is the lead sponsor of 11 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
The study lot will be comprised by 100 patients out of which:
Inclusion Criteria:
Substudy 1:
Substudy 2:
Exclusion Criteria: (for both substudies)
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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.
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.
Time frame: 2 years
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
Time frame: 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
Time frame: 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
Time frame: 2 years
Plan to share: 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
Supporting information: Study protocol, Statistical analysis plan, Clinical study report
Time frame: Data will become available immediately after completion of the enrolment and will remain available for at least 5 years
Ran from Apr 2018 to primary completion in Sep 2020, 29 months.
Of 58 observational studies under Coronary Stenosis, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 15 and three quarters within 143. This study's 29 months is close to that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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