Ignite Creation Date:
2024-05-05 @ 9:49 PM
Last Modification Date:
2024-10-26 @ 10:10 AM
Study NCT ID:
NCT00979199
Status:
COMPLETED
Last Update Posted:
2014-07-21
First Post:
2009-09-16
Brief Title:
Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Sponsor:
Fondazione CNRRegione Toscana G Monasterio Pisa Italy
Organization:
Fondazione CNRRegione Toscana G Monasterio Pisa Italy
Study Overview
Official Title:
Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease
Status:
COMPLETED
Status Verified Date:
2014-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
EVINCI
Brief 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
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 andor 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
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 andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| FPVII grant 222915 | Other GrantFunding Number | European Commission FPVII Health Grant N 222915 | None |
| European Commission | OTHER_GRANT | None | None |