Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease (EVINCI)
|ClinicalTrials.gov Identifier: NCT00979199|
Recruitment Status : Completed
First Posted : September 17, 2009
Results First Posted : July 21, 2014
Last Update Posted : July 21, 2014
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).
|Condition or disease||Intervention/treatment||Phase|
|Ischemic Heart Disease||Other: Non invasive cardiac imaging||Phase 4|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||697 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease|
|Study Start Date :||February 2009|
|Primary Completion Date :||July 2010|
|Study Completion Date :||June 2012|
Non invasive cardiac imaging
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
Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
- Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement [ Time Frame: 3 months from enrollment ]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).
- Cost-benefit and Cost-effectiveness Analysis [ Time Frame: 3 months ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00979199
|Viareggio, Lucca, Italy, 55100|
|QUEEN MARY Hospital London|
|London, United Kingdom|
|London, United Kingdom|
|Principal Investigator:||Danilo Neglia, MD, PhD||Fondazione Toscana G. Monasterio, Pisa, Italy|