Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease

Study Overview
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Brief Summary
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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
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Objectives of the study 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). 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. 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). 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.

Official Title
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Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease

Conditions
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Ischemic Heart Disease

Intervention / Treatment
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* Other: Non invasive cardiac imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with intermediate (>20%, <90%) risk of IHD based on age,gender,symptoms and exercise stress test results Exclusion Criteria: Age < 30 Yrs or > 75 yrs Pregnancy (suspected or ascertained) LV Dysfunction (LVEF < 35% by Echo or other method) Low (< =20%) or high (>=90%) probability of CAD Acute Coronary Syndrome Prolonged (> 20 minutes) chest pain De novo or accelerated angina Hemodynamic or electrical instability Recent ST-T segment or T wave changes of ischemic nature Acute myocardial infarction with or without ST segment elevation Elevated serum cardiac markers of necrosis Known diagnosis of CAD Previously known myocardial infarction Previous PCI Previous CABG Persistent atrial fibrillation or advanced AV Block Asthma or chronic treatment with aminophylline Recent (<6 months) cerebral ischemic attack Known significant carotid stenosis or vascular aneurisms Asthma or chronic treatment with aminophylline Active cancer Severe hypertension. Patients cannot withdraw therapy for 12 hours. Congenital heart disease Significant valvular disease Cardiomyopathy (e.g. DCM, HCM, ARVC, Amyloidosis) Inability to provide an informed consent

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Non invasive cardiac imaging<br>Intervention: Non invasive cardiac imaging. 'Anatomical' information provided by CTCA 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. | Other: Non invasive cardiac imaging<br>* Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement | The outcome measure is the number of participants who received the diagnosis of IHD at invasive coronary angiography coupled with FFR measurements (in case of intermediate coronary lesions). | 3 months from enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-benefit and Cost-effectiveness Analysis | Different non invasive imaging modalities are compared in terms of a cost-effectiveness analysis where costs include direct and indirect costs incurred as a consequence of the use of each modality or combination of modalities and effectiveness is the diagnostic accuracy with invasive diagnosis of IHD as end-point. | 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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IHD, CAD, Non invasive imaging, SPECT, PET, CMR, Echocardiography