Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Condition: Ischemic Heart Disease
MeSH terms: Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia
Study type: Interventional
Phase: Phase 4

Summary: 
      Main purpose of the study:

      To comparatively assess the diagnostic performance of non invasive anatomical and functional
      imaging modalities to detect significant obstructive coronary artery disease as demonstrated
      at invasive coronary angiography and functional evaluation of coronary lesions (fractional
      flow reserve).
    

Detailed description: 
      Objectives of the study

        1. To test the accuracy of anatomical and functional non-invasive cardiac imaging in the
           diagnosis of IHD. To this purpose the "anatomical" information provided by CTA is
           obtained in every patient together with the "functional" information provided by stress
           radionuclide cardiac imaging (SPECT or PET), to assess myocardial perfusion, and/or by
           stress MRI or ECHO imaging to assess myocardial contraction. Non-invasive results are
           tested against invasive reference standards. The latter consists of invasive coronary
           angiography integrated by invasive measurement of fractional flow reserve (to assess the
           hemodynamic relevance of intermediate coronary stenoses).

        2. To test the accuracy of integrated models, including clinical variables, risk factors
           and circulating biomarkers, to predict significant obstructive coronary artery disease
           in patients with chronic angina-like symptoms. To correlate biohumoral profiles with the
           coronary anatomical-functional phenotype as obtained by non invasive imaging in the same
           patients. To reach these goals the clinical characterization of patients (collected
           before non-invasive imaging) and the laboratory characterization (that includes novel
           biomarkers of cardiovascular risk) are compared with patient characterization derived
           from non invasive "anatomic-functional" imaging and with invasive diagnosis of
           significantly obstructive coronary disease.

        3. To develop an advanced clinical and imaging reporting tool in cardiology. An informatics
           platform is developed to synthetically and clearly present the integrated clinical and
           imaging diagnostic profile of individual patients. A multimodal imaging reporting tool
           is developed including tools for "image fusion" of different imaging modalities (CT,
           SPECT, PET, MRI).

        4. To define the most cost-effective work-up for the diagnosis and characterization of IHD.
           To this purpose the costs and the procedural risks (including radiation exposure) of
           non-invasive and invasive diagnostic procedures are prospectively collected.
           Cost-benefit and cost-effectiveness analyses is conducted alongside the EVINCI-study
           clinical trial.
    

Intervention name(s): Non invasive cardiac imaging
Intervention type(s): Other
Intervention description(s): Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic
Keywords: IHD; CAD; Non invasive imaging; SPECT; PET; CMR; Echocardiography