Clinical trial NCT00979199: Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease
Official title: Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Ischemic Heart Disease
Keywords: IHD
CAD
Non invasive imaging
SPECT
PET
CMR
Echocardiography
Lead sponsor: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
Sponsor class: OTHER_GOV
Collaborators: name: European Commission
First posted: 2009-09-17
Enrollment: 697
Sex: ALL
Minimum age (years): 30
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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.

Eligibility 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

Primary outcomes:
measure: Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement
timeFrame: 3 months from enrollment
Secondary outcomes:
measure: Cost-benefit and Cost-effectiveness Analysis
timeFrame: 3 months
Other outcomes:
Locations:
city: Turku
country: Finland
facility: U.Turku
city: Paris
country: France
facility: APHP
city: Goeppingen
country: Germany
facility: KAE Goeppingen
city: Munich
country: Germany
facility: TUM
city: Viareggio
country: Italy
facility: Ospedale Versilia
state: Lucca
city: Genova
country: Italy
facility: UniGE
city: Naples
country: Italy
facility: UniNA
city: Pisa
country: Italy
facility: CNR
city: Pisa
country: Italy
facility: FGM
city: Leiden
country: Netherlands
facility: LUMC
city: Warsaw
country: Poland
facility: NIC
city: Barcelona
country: Spain
facility: Huvhebron
city: Madrid
country: Spain
facility: SERMAS
city: Zurich
country: Switzerland
facility: UZH
city: London
country: United Kingdom
facility: QUEEN MARY Hospital London
city: London
country: United Kingdom
facility: RBHT
Study officials:
affiliation: Fondazione Toscana G. Monasterio, Pisa, Italy
name: Danilo Neglia, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.