Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
NCT ID: NCT00979199
Last Updated: 2014-07-21
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE4
697 participants
INTERVENTIONAL
2009-02-28
2012-06-30
Brief Summary
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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).
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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.
Non invasive cardiac imaging
Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
Interventions
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Non invasive cardiac imaging
Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
30 Years
75 Years
ALL
No
Sponsors
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European Commission
OTHER
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
OTHER_GOV
Responsible Party
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Danilo Neglia
MD
Principal Investigators
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Danilo Neglia, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Fondazione Toscana G. Monasterio, Pisa, Italy
Locations
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U.Turku
Turku, , Finland
APHP
Paris, , France
KAE Goeppingen
Göppingen, , Germany
TUM
Munich, , Germany
Ospedale Versilia
Viareggio, Lucca, Italy
UniGE
Genova, , Italy
UniNA
Naples, , Italy
CNR
Pisa, , Italy
FGM
Pisa, , Italy
LUMC
Leiden, , Netherlands
NIC
Warsaw, , Poland
Huvhebron
Barcelona, , Spain
SERMAS
Madrid, , Spain
UZH
Zurich, , Switzerland
QUEEN MARY Hospital London
London, , United Kingdom
RBHT
London, , United Kingdom
Countries
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References
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Caselli C, De Caterina R, Smit JM, Campolo J, El Mahdiui M, Ragusa R, Clemente A, Sampietro T, Clerico A, Liga R, Pelosi G, Rocchiccioli S, Parodi O, Scholte A, Knuuti J, Neglia D; EVINCI and SMARTool. Triglycerides and low HDL cholesterol predict coronary heart disease risk in patients with stable angina. Sci Rep. 2021 Oct 20;11(1):20714. doi: 10.1038/s41598-021-00020-3.
Caselli C, Del Turco S, Ragusa R, Lorenzoni V, De Graaf M, Basta G, Scholte A, De Caterina R, Neglia D. Association of PCSK9 plasma levels with metabolic patterns and coronary atherosclerosis in patients with stable angina. Cardiovasc Diabetol. 2019 Oct 31;18(1):144. doi: 10.1186/s12933-019-0949-3.
Carpeggiani C, Picano E, Brambilla M, Michelassi C, Knuuti J, Kauffman P, Underwood SR, Neglia D; EVINCI Study Investigators. Variability of radiation doses of cardiac diagnostic imaging tests: the RADIO-EVINCI study (RADIationdOse subproject of the EVINCI study). BMC Cardiovasc Disord. 2017 Feb 16;17(1):63. doi: 10.1186/s12872-017-0474-9.
Neglia D, Rovai D, Caselli C, Pietila M, Teresinska A, Aguade-Bruix S, Pizzi MN, Todiere G, Gimelli A, Schroeder S, Drosch T, Poddighe R, Casolo G, Anagnostopoulos C, Pugliese F, Rouzet F, Le Guludec D, Cappelli F, Valente S, Gensini GF, Zawaideh C, Capitanio S, Sambuceti G, Marsico F, Perrone Filardi P, Fernandez-Golfin C, Rincon LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Maki M, Lorenzoni V, Turchetti G, Carpeggiani C, Marinelli M, Puzzuoli S, Mangione M, Marcheschi P, Mariani F, Giannessi D, Nekolla S, Lombardi M, Sicari R, Scholte AJ, Zamorano JL, Kaufmann PA, Underwood SR, Knuuti J; EVINCI Study Investigators. Detection of significant coronary artery disease by noninvasive anatomical and functional imaging. Circ Cardiovasc Imaging. 2015 Mar;8(3):e002179. doi: 10.1161/CIRCIMAGING.114.002179.
Related Links
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Other Identifiers
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European Commission
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
FPVII grant 222915
Identifier Type: -
Identifier Source: secondary_id
EVINCI
Identifier Type: -
Identifier Source: org_study_id
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