Ignite Creation Date:
2024-05-06 @ 10:58 AM
Last Modification Date:
2024-10-26 @ 12:37 PM
Study NCT ID:
NCT03391908
Status:
COMPLETED
Last Update Posted:
2022-08-02
First Post:
2017-12-31
Brief Title:
Multiomics and Imaging-based Assessment of Vulnerable Coronary Plaques in Acute Coronary Syndromes
Sponsor:
Cardio Med Medical Center
Organization:
Cardio Med Medical Center
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MultiPlaque
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None