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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2009 by Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
ClinicalTrials.gov Identifier:
NCT00979199
First received: September 16, 2009
Last updated: NA
Last verified: September 2009
History: No changes posted
  Purpose

Main purpose of the study:

To test the impact of a combined non invasive, "anatomo-functional" cardiac imaging strategy on the detection and management of ischemic heart disease.


Condition Intervention Phase
Ischemic Heart Disease
Other: Invasive coronary angiography
Other: Stress imaging
Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
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:
  • Diagnostic algorithm for IHD [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Cost-benefit and cost-effectiveness analysis [ Time Frame: 36 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 700
Study Start Date: February 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Non invasive assessment Other: Stress imaging
Exercise, dobutamine or dipyridamole stress test.
Active Comparator: Invasive assessment Other: Invasive coronary angiography
Invasive coronary angiography assessment of stenosis and FFR

Detailed Description:

Objectives of the study

  1. To test the accuracy of "anatomo-functional" non-invasive cardiac imaging in the diagnosis of IHD. To this purpose the "anatomic" information provided by CTA will be combined in every patient with the "functional" information provided by radionuclide cardiac imaging (SPECT or PET) to assess the relevance of coronary disease by its effects on myocardial perfusion. Additionally, MRI or ECHO imaging will be performed to assess the relevance of coronary disease by its effects on myocardial contraction (and perfusion Non-invasive results will be tested against invasive reference standards. The latter will consist of ICA integrated by intra-coronary pressure wire (to assess the hemodynamic relevance of coronary stenoses), by IVUS (to detect early coronary atherosclerosis) and by Doppler flow wire (to recognize microvascular dysfunction).
  2. To evaluate the association of risk profiles assessed from clinical data and biomarkers with "anatomo-functional" patient characterization and outcome. To reach this goal the clinical characterization of patients (collected before non-invasive imaging) and the laboratory characterization (that will include novel biomarkers of cardiovascular risk) will be compared with patient characterization derived from "anatomo-functional" imaging and with patient outcome during the follow-up.
  3. To develop an advanced clinical and imaging reporting and integrated decision making tool in cardiology. In cooperation with InforSense (P15-INF), an informatics platform will be developed to synthetically and clearly present the integrated clinical and imaging diagnostic profile of individual patients. Specialized clinical decision making tools will be part of the platforms based on "image fusion" of different imaging modalities (CT, SPECT, PET, MRI) and their integrated analysis with other clinical data. The tools will target both researchers and physicians and would speed-up the deployment of the novel results obtained within EVINCI-study, and similar future studies, to clinicians at the point of care.
  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 will be prospectively collected. Cost-benefit and cost-effectiveness analyses will be 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 aminophilline
  • 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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00979199

Locations
Finland
U.Turku Recruiting
Turku, Finland
Contact: Juani Knuuti    35823132842      
Principal Investigator: Juani Knuuti         
France
APHP Not yet recruiting
Paris, France
Contact: Francois Rouzet         
Sub-Investigator: Francois Rouzet         
Germany
TUM Not yet recruiting
Munich, Germany
Contact: Stephan Nekolla       s.nekolla@lrz.tu-muenchen.de   
Principal Investigator: Stephan Nekolla         
Italy
UniGE Not yet recruiting
Genova, Italy
Contact: GianMario Sambuceti         
Principal Investigator: GianMario Sambuceti         
UniNA Not yet recruiting
Naples, Italy
Contact: Pasquale Perrone Filardi         
Principal Investigator: Pasquale Perrone Filardi         
FGM Recruiting
Pisa, Italy
Contact: Alessia Gimelli       agimelli@ifc.cnr.it   
Sub-Investigator: Alessia Gimelli         
CNR Recruiting
Pisa, Italy
Contact: Danilo Neglia    39 0503152019      
Principal Investigator: Danilo Neglia         
Netherlands
LUMC Active, not recruiting
Leiden, Netherlands
Poland
NIC Recruiting
Warsaw, Poland
Contact: Anna Teresinska       ateresinska@ikard.pl   
Principal Investigator: Anna Teresinska         
Spain
IR-HSCSP Not yet recruiting
Barcelona, Spain
Contact: Albert Flotats       aflotats@santpau.es   
Principal Investigator: Albert Flotats         
Huvhebron Not yet recruiting
Barcelona, Spain
Contact: Santiago Aguade         
Principal Investigator: Santiago Aguade         
SERMAS Recruiting
Madrid, Spain
Contact: Jose' Zamorano       zamorano@secardiologia.es   
Principal Investigator: Jose' Zamorano         
Sub-Investigator: Covadonga Fernández-Golfín         
Switzerland
UZH Not yet recruiting
Zurich, Switzerland
Contact: Philipp Kaufmann       pak@usz.ch   
Principal Investigator: Philipp Kauffman         
United Kingdom
RBHT Not yet recruiting
London, United Kingdom
Contact: Richard Underwood         
Principal Investigator: Richard Underwood         
Sponsors and Collaborators
Fondazione C.N.R./Regione Toscana "G. Monasterio", Pisa, Italy
  More Information

Additional Information:
No publications provided

Responsible Party: Danilo Neglia, National Research Council, Italy
ClinicalTrials.gov Identifier: NCT00979199     History of Changes
Other Study ID Numbers: EVINCI, Seventh European Framework, grant 222915
Study First Received: September 16, 2009
Last Updated: September 16, 2009
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:
CHD
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 April 23, 2014