The Assessment Of Myocardial Viability Based On CTA/MRI Hybrid Models
Condition: Acute Myocardial Infarction; Myocardial Viability; Vulnerable Coronary Plaques; Coronary Stenosis; Myocardial Fibrosis
MeSH terms: Myocardial Infarction; Coronary Stenosis; Infarction
Study type: Observational

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.
    

Detailed 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.
    

Intervention name(s): Speckle Tracking echocardiography
Intervention type(s): Diagnostic Test
Intervention description(s): Diagnostic tests:
Speckle Tracking echocardiography with analyzing the myocardial strain, myocardial velocities, 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.
Diagnostic tests:
Laboratory assessment for the evaluation of the level of hs-CRP and myocardial necrosis biomarkers
Other intervention name(s): 128-multislice CCTA; MRI; Laboratory assessment
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        100 subjects with documented ST Segment elevation myocardial infarction at 30 days prior to
        study enrollment.
      
Biospecimen description: 
      venous blood samples for evaluation of the level of hs-CRP, myocardial necrosis markers
    
Keywords: biomarkers; myocardial infarction; hybrid images; myocardial viability; CCTA; MRI