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
• Sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• Collaborator: European Commission
• Information provided by (Responsible Party): Danilo Neglia, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

Study Description

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).

Condition or disease	Intervention/treatment	Phase
Ischemic Heart Disease	Other: Non invasive cardiac imaging	Phase 4

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 697 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease
• Study Start Date: February 2009
• Actual Primary Completion Date: July 2010
• Actual Study Completion Date: June 2012

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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).

Secondary Outcome Measures :

1. 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.

Eligibility Criteria

• Ages Eligible for Study: 30 Years to 75 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Finland

U.Turku

Turku, Finland

France

APHP

Paris, France

Germany

KAE Goeppingen

Goeppingen, Germany

TUM

Munich, Germany

Italy

Ospedale Versilia

Viareggio, Lucca, Italy, 55100

UniGE

Genova, Italy

UniNA

Naples, Italy

CNR

Pisa, Italy

FGM

Pisa, Italy

Netherlands

LUMC

Leiden, Netherlands

Poland

NIC

Warsaw, Poland

Spain

Huvhebron

Barcelona, Spain

SERMAS

Madrid, Spain

Switzerland

UZH

Zurich, Switzerland

United Kingdom

QUEEN MARY Hospital London

London, United Kingdom

RBHT

London, United Kingdom

Sponsors and Collaborators

Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy

European Commission

Investigators

• Principal Investigator: Danilo Neglia, MD, PhD; Fondazione Toscana G. Monasterio, Pisa, Italy

More Information

Additional Information:

Related Info 

Related Info 

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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, Aguadé-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, Fernández-Golfín C, Rincón LM, Graner FP, de Graaf MA, Fiechter M, Stehli J, Gaemperli O, Reyes E, Nkomo S, Mäki 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). pii: e002179. doi: 10.1161/CIRCIMAGING.114.002179.

• Responsible Party: Danilo Neglia, MD, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• ClinicalTrials.gov Identifier: NCT00979199
• Other Study ID Numbers: EVINCI; European Commission ( Other Grant/Funding Number: European Commission, FPVII Health Grant N. 222915 ); FPVII grant 222915
• First Posted: September 17, 2009
• Results First Posted: July 21, 2014
• Last Update Posted: July 21, 2014
• Last Verified: June 2014

Keywords provided by Danilo Neglia, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

IHD; CAD; Non invasive imaging; SPECT; PET; CMR; Echocardiography

Additional relevant MeSH terms:

Heart Diseases; Myocardial Ischemia; Coronary Artery Disease; Ischemia; Pathologic Processes; Cardiovascular Diseases; Vascular Diseases; Coronary Disease; Arteriosclerosis; Arterial Occlusive Diseases