Evaluation of Integrated Cardiac Imaging in Ischemic Heart Disease (EVINCI)

This study has been completed.
Sponsor:
Collaborator:
European Commission
Information provided by (Responsible Party):
Danilo Neglia, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier:
NCT00979199
First received: September 16, 2009
Last updated: June 19, 2014
Last verified: June 2014
  Purpose

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 Intervention Phase
Ischemic Heart Disease
Other: Non invasive cardiac imaging
Phase 4

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Evaluation of Integrated Cardiac Imaging for the Detection and Characterization of Ischemic Heart Disease

Resource links provided by NLM:


Further study details as provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:

Primary Outcome Measures:
  • Diagnosis of IHD at Invasive Coronary Angiography and FFR Measurement [ Time Frame: 3 months from enrollment ] [ Designated as safety issue: No ]
    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:
  • Cost-benefit and Cost-effectiveness Analysis [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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.


Enrollment: 697
Study Start Date: February 2009
Study Completion Date: June 2012
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

Ages Eligible for Study:   30 Years to 75 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00979199

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
FGM
Pisa, Italy
CNR
Pisa, Italy
Netherlands
LUMC
Leiden, Netherlands
Poland
NIC
Warsaw, Poland
Spain
Huvhebron
Barcelona, Spain
SERMAS
Madrid, Spain
Switzerland
UZH
Zurich, Switzerland
United Kingdom
RBHT
London, United Kingdom
QUEEN MARY Hospital London
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:
No publications provided

Responsible Party: Danilo Neglia, MD, Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier: NCT00979199     History of Changes
Other Study ID Numbers: EVINCI, European Commission, FPVII grant 222915
Study First Received: September 16, 2009
Results First Received: April 23, 2014
Last Updated: June 19, 2014
Health Authority: Italy: Ministero della salute
France:Ministere de la Sante
UK:Department of Health GTAC
Spain:Ministerio de Sanidad y Politica Social
Germany:Bundesministerium für Gesundheit
Finland:Sosiaali- ja terveyspalvelut
Poland: Ministerstwo Zdrowia

Keywords provided by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy:
IHD
CAD
Non invasive imaging
SPECT
PET
CMR
Echocardiography

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Heart Diseases
Ischemia
Coronary Disease
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on July 31, 2014