NCT00979199

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
697

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started Feb 2009

Typical duration for phase_4

Geographic Reach
9 countries

16 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

September 16, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 17, 2009

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2010

Completed
1.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2012

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

July 21, 2014

Completed
Last Updated

July 21, 2014

Status Verified

June 1, 2014

Enrollment Period

1.4 years

First QC Date

September 16, 2009

Results QC Date

April 23, 2014

Last Update Submit

June 19, 2014

Conditions

Ischemic Heart Disease

Keywords

IHDCADNon invasive imagingSPECTPETCMREchocardiography

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

  • Cost-benefit and Cost-effectiveness Analysis

    3 months

Study Arms (1)

Non invasive cardiac imaging

OTHER

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

Interventions

Non invasive cardiac imagingOTHER

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

Non invasive cardiac imaging

Eligibility Criteria

Age30 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with intermediate (\>20%, \<90%) risk of IHD based on age,gender,symptoms and exercise stress test results

You may not qualify if:

  • 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
  • +11 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (16)

U.Turku

Turku, Finland

Location

APHP

Paris, France

Location

KAE Goeppingen

Göppingen, Germany

Location

TUM

Munich, Germany

Location

Ospedale Versilia

Viareggio, Lucca, 55100, Italy

Location

UniGE

Genova, Italy

Location

UniNA

Naples, Italy

Location

CNR

Pisa, Italy

Location

FGM

Pisa, Italy

Location

LUMC

Leiden, Netherlands

Location

NIC

Warsaw, Poland

Location

Huvhebron

Barcelona, Spain

Location

SERMAS

Madrid, Spain

Location

UZH

Zurich, Switzerland

Location

QUEEN MARY Hospital London

London, United Kingdom

Location

RBHT

London, United Kingdom

Location

Related Publications (4)

  • 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.

    PMID: 34671067DERIVED

  • 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.

    PMID: 31672148DERIVED

  • 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.

    PMID: 28202051DERIVED

  • 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.

    PMID: 25711274DERIVED

Related Links

MeSH Terms

Conditions

Myocardial Ischemia

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesVascular Diseases

Results Point of Contact

Title
Dr. Danilo Neglia
Organization
CNR Institute of Clinical Physiology, Pisa, Italy and Fondazione Toscana G. Monasterio, Pisa, Italy
dneglia@ifc.cnr.it
+390503152019

Study Officials

  • Danilo Neglia, MD, PhD

    Fondazione Toscana G. Monasterio, Pisa, Italy

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

September 16, 2009

First Posted

September 17, 2009

Study Start

February 1, 2009

Primary Completion

July 1, 2010

Study Completion

June 1, 2012

Last Updated

July 21, 2014

Results First Posted

July 21, 2014

Record last verified: 2014-06

Locations

FR(1)IT(5)FI(1)DE(2)NL(1)PL(1)ES(2)GB(2)CH(1)