Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04397198 |
| Other study ID # |
CM0120-HYBH |
| Secondary ID |
|
| Status |
Completed |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
July 6, 2020 |
| Est. completion date |
June 1, 2022 |
Study information
| Verified date |
May 2020 |
| Source |
Cardio Med Medical Center |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The aim of HYBRIDHEART study is to develop new imagistic prototype for a complex evaluation
of the myocardial viability by superposing computed tomographic angiographic polar maps of
the myocardium with magnetic resonance imaging contractile maps in subjects who suffered an
acute myocardial infarction. Moreover, the study will evaluate the association of myocardial
viability with the level of inflammatory markers and the percent of myocardial fibrosis, also
will correlate the imaging-derived parameters with the inflammatory status of the patients,
left ventricular function, ischemic time and major adverse cardiovascular events (MACE) rate.
Description:
The HYBRIDHEART study is a prospective, observational study that will be conducted in the
Laboratory of Advanced Research in Cardiac Multimodal Imaging of Cardio Med Medical Center
Tîrgu Mureş, Romania.
The project will include 100 subjects with documented ST Segment elevation myocardial
infarction at 30 days prior to study enrollment. The level of inflammatory biomarkers will be
express using hs-CRP levels at day 1 and day 5 post the acute event. All the subjects will
undergo coronary computer tomography angiography (CCTA), magnetic resonance (MRI), 3D
contrast enhancement echocardiography, speckle tracking echocardiography at the moment of the
inclusion. Also, venous blood samples will be collected for the determination of the level of
hs-CRP and myocardial necrosis biomarkers such as I Troponin, myocardial fraction of creatine
kinase (CK-MB).
The imagistic acquisitions obtained from all the techniques used, will be processed using a
supercomputer set up with computational simulations applications for the myocardial kinetics.
All the MRI images will be analyzed using Medis Q-mass software in order to quantify the
myocardial fibrosis, and the CCTA images will be analyzed using SyngoVia. Frontier software,
for the plaques evaluation. The images will be superposed obtaining hybrid CCTA-MRI images
that will be analyzed in order to correlate the degree of plaque vulnerability, the percent
of myocardial scar, the percent of viable myocardial tissue, calculating the total Calcium
Scoring, Syntax score.
The study will be conducted over a period of 2 years, in which the subjects will be examined
at the moment of inclusion and during the follow-up visits. Will be performed the follow up
of the subjects at 1, 3 and 6 months and 1 year after the inclusion period. At 1 month follow
up the subjects will be examined, will be performed echocardiography. Moreover during follow
up will be done telephonic visits with target questions . MACE rate will be assessed at 6
month follow-up and 1 year follow up visits.
Study objectives:
Primary: to develop new imagistic markers for a complex evaluation of the myocardial
viability, by superposing computed tomographic angiographic polar maps of the myocardium with
MRI contrast enhancement maps in subjects with myocardial infarction.
Secondary: to evaluate the association of the percent of viable myocardium with the level of
inflammatory markers. To correlate the plaque vulnerability markers with the percent of
myocardial fibrosis, the inflammatory status of the subjects, left ventricular function,
ischemic time and the rate of MACE, Calcium Score, Syntax score
Study timeline:
Baseline (day0) Obtain a written consent from the participants on study consent form. Verify
inclusion/exclusion criteria Assess the demographical data of the participants, medical
history, possible known allergies, medication history, alcohol, tobacco use history Physical
examination record Blood pressure record 12-lead ECG Collect venous blood samples Performing
CCTA, MRI, Speckle Tracking Echocardiography using standard protocols
Visit 1 (month 1) Physical examination record 12-lead ECG Blood pressure record Transthoracic
Echocardiography
Visit 2 (month 3) Telephone visit with target questions, all the answers recorded in study
forms.
Visit 3 (month 6) End point evaluation 12-lead ECG Blood pressure record Transthoracic
Echocardiography
Visit 4 (12 months) End point evaluation 12-lead ECG Blood pressure record Transthoracic
Echocardiography Performing CCTA
Study procedures:
Clinical examinations 12 lead ECG Laboratory assessment for the evaluation of the level of
hs-CRP and myocardial necrosis biomarkers (I Troponin, CK-MB) Speckle Tracking
echocardiography with analyzing the myocardial strain, myocardial velocities, left
ventricular function 128-multislice CCTA with the evaluation of the Calcium Scoring (total
and local) , identifying the coronary stenosis, evaluation of the plaque vulnerability
degree, assess polar maps of the myocardium.
MRI for the evaluation of the percentage of myocardial scar, also the percentage of the
viable myocardial tissue using contrast late enhancement sequences, measuring myocardial
fibrosis using Q-mass software.
Data collection:
A dedicated database will be created, including all the demographical data and data regarding
the acute myocardial infarction, such as: infarct location, time of ischemia, ECG changes,
levels of the necrosis markers, hs-CPR, MRI findings, CCTA findings, speckle tracking
parameters.
