Assessment of Lesion-Associated Myocardial Ischemia Based on Fusion Coronary CT Imaging
Condition: Myocardial Ischemia; Myocardial Viability; Coronary Stenosis; Vulnerable Coronary Plaques
MeSH terms: Myocardial Ischemia; Coronary Artery Disease; Coronary Stenosis; Ischemia
Study type: Observational

Summary: 
      The aim of the Fused-Heart study is to investigate the impact of a coronary artery stenosis
      on myocardial function and viability, based on advanced fusion imaging techniques derived
      from CCTA.

      Moreover the study will investigate the correlation between morphology and composition of
      atheromatous plaques located in a coronary artery and myocardial ischemia in the territory
      irrigated by the same coronary artery.
    

Detailed description: 
      The FUSE-HEART study is a prospective, observational, single-center, cohort study that will
      be conducted in the Laboratory of Advanced Research in Cardiac Multimodal Imaging of Cardio
      Med Medical Center Targu Mures, Romania.

      The study will include 100 subjects with coronary lesions depicted by CCTA examination. The
      study population will consist in: (1) patients with anatomically significant coronary lesions
      (at least 50% luminal narrowing) on native coronary arteries, or (2) patients surviving an
      acute myocardial infarction, revascularized or not. In all patients, presence of
      vulnerability features in the atheromatous plaques will be studied and the vulnerability
      score will be calculated for each plaque, consisting in one point added for each of the
      following vulnerability markers: positive remodeling, napkin-rink sign, presence of low
      density plaque or spotty calcium within the plaque. In addition, following 3D fusion of the
      images of the coronary tree with the images reflecting wall motion, the correspondence
      between plaque morphology and composition on one hand, and wall motion in the corresponding
      distribution territory of that coronary artery, will be studied based on fused models.

      The study will be conducted over a period of 2 years, in which patients will be examined at
      baseline, with a projected recruitment period of 1 year and will be followed-up 1 year for
      MACE.

      Study objectives:

      Primary: to investigate the impact of a coronary artery stenosis on myocardial function and
      viability, based on advanced fusion imaging techniques derived from CCTA.

      Secondary: to investigate the correlation between morphology and composition of atheromatous
      plaques located in a coronary artery and myocardial ischemia in the territory irrigated by
      the same coronary artery.

      Study timeline:

      • Baseline (day 0)-Obtain and document consent from participant on study consent form.

      Verify inclusion/exclusion criteria. Obtain demographic information, medical history,
      medication history, alcohol and tobacco use history. Record results of physical examinations
      and 12-lead ECG.Collect blood specimens (complete blood count, biochemistry and inflammatory
      biomarkers).Imaging procedures: CCTA-Image processing - quantification of coronary stenosis,
      characterization of vulnerability markers, 3D reconstruction, extension and characterization
      of wall motion. Deliver fused 3D images

      • Visit 1 (month 1)-Record results of physical examinations, 12-lead ECG, blood pressure, and
      medical history. MACE assessment Visit 2 (month 3) -Telephone visit with target questions,
      all the answers recorded in study forms Visit 3 (month 6) - Record results of physical
      examinations, 12-lead ECG, blood pressure, and medical history. MACE assessment

      Final study visit (month 12)- Record results of physical examinations, medical
      history,12-lead ECG, blood pressure, transthoracic 2-D echocardiography. End-point and MACE
      evaluation.

      Study procedures:

        -  Medical history, clinical examination, laboratory tests (complete blood count,
           biochemistry, inflammatory biomarkers: hs-CRP, MMP, IL6 and NT-pro-BNP);

        -  12-lead ECG

        -  2D transthoracic echocardiography

        -  CCTA

        -  Computerized postprocessing and fused images

      Data collection:

      All the information will be collected in a dedicated database including medical history,
      medication, imaging features provided by cardiac ultrasound, CCTA and fused images resulting
      from imaging post-processing.
    

Intervention name(s): 128 Multislice CT coronary angiography; 2D Cardiac Transthoracic Echocardiography; Laboratory Blood tests
Intervention type(s): Diagnostic Test; Diagnostic Test; Diagnostic Test
Intervention description(s): 128 Multislice CT coronary angiography with the evaluation of coronary stenosis, the plaque vulnerability markers ( necrotic core, low attenuation plaque, spotty calcifications, napkin ring sign, positive remodeling), asses polar maps of the myocardium; 2D Cardiac Transthoracic Echocardiography with the evaluation of the cardiac cavity dimensions; Laboratory tests for evaluations the level of inflammatory biomarkers ( hs-CRP, MMP, IL6 and NT-pro-BNP), complete blood count, biochemestry
Other intervention name(s): CCTA
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        The study will include 100 subjects with coronary lesions depicted by CCTA examination. The
        study population will consist in: (1) patients with anatomically significant coronary
        lesions (at least 50% luminal narrowing) on native coronary arteries, or (2) patients
        surviving an acute myocardial infarction, revascularized or not.
      
Biospecimen description: 
      venous blood samples for complete blood count, biochemistry, inflammatory biomarkers
    
Keywords: Fusion imaging; CCTA; Myocardial viability; Vulnerable coronary plaques