Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease

Ischemic Heart Disease Clinical Trial

— EVINCI  

Official title:

Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00979199
• Other study ID #: EVINCI
• Secondary ID: European Commiss
• Status: Completed
• Phase: Phase 4
• First received: September 16, 2009
• Last updated: June 19, 2014
• Start date: February 2009
• Est. completion date: June 2012

Study information

• Verified date: June 2014
• Source: Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
• Contact: n/a
• Is FDA regulated: No
• Health authority: Italy: Ministero della saluteFrance:Ministere de la SanteUK:Department of Health GTACSpain:Ministerio de Sanidad y Politica SocialGermany:Bundesministerium für GesundheitFinland:Sosiaali- ja terveyspalvelutPoland: Ministerstwo Zdrowia
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 697
• Est. completion date: June 2012
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 30 Years to 75 Years

Eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Coronary Artery Disease
• Heart Diseases
• Ischemia
• Ischemic Heart Disease
• Myocardial Ischemia

Intervention

Other:
• Non invasive cardiac imaging
Non invasive cardiac imaging consists of CTCA combined with one Stress Imaging Test

Locations

Country	Name	City	State
Finland	U.Turku	Turku
France	APHP	Paris
Germany	KAE Goeppingen	Goeppingen
Germany	TUM	Munich
Italy	UniGE	Genova
Italy	UniNA	Naples
Italy	CNR	Pisa
Italy	FGM	Pisa
Italy	Ospedale Versilia	Viareggio	Lucca
Netherlands	LUMC	Leiden
Poland	NIC	Warsaw
Spain	Huvhebron	Barcelona
Spain	SERMAS	Madrid
Switzerland	UZH	Zurich
United Kingdom	QUEEN MARY Hospital London	London
United Kingdom	RBHT	London

Sponsors (2)

Lead Sponsor	Collaborator
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy	European Commission

Countries where clinical trial is conducted

Finland,  France,  Germany,  Italy,  Netherlands,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement	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).	3 months from enrollment	No
Secondary	Cost-benefit and Cost-effectiveness Analysis	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.	3 months	No

External Links

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