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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT03049995
Date of registration: 02/02/2017
Prospective Registration: No
Primary sponsor: Fatebenefratelli Hospital
Public title: Stress Echo 2020 - The International Stress Echo Study SE2020
Scientific title: The International Stress Echo Study in Ischemic and Non-ischemic Heart Disease
Date of first enrolment: November 2016
Target sample size: 300
Recruitment status: Recruiting
URL:  https://clinicaltrials.gov/show/NCT03049995
Study type:  Observational [Patient Registry]
Study design:   
Phase:  N/A
Countries of recruitment
Italy
Contacts
Name:     Quirino Ciampi, MD
Address: 
Telephone:
Email:
Affiliation: 
Name:     Quirino Ciampi, MD
Address: 
Telephone:
Email: qciampi@gmail.com
Affiliation: 
Name:     Quirino Ciampi, MD
Address: 
Telephone:
Email:
Affiliation:  Fatebenefratelli Hospital
Key inclusion & exclusion criteria

Inclusion criteria shared by all projects are:

- age < 85 years and > 18 years (except for project 7 regarding repaired tetralogy of
Fallot and project 10 regarding healthy relatives of patients with familial disease,
in which children > 10 years can enter the study after parental consent);

- technically acceptable acoustic window at rest (with at least 14 segments well
visualized in at least one projection).

Exclusion criteria shared by all projects are:

- presence of prognosis-limiting comorbidities, such as advanced cancer, reducing life
expectancy to < 1 year;

- pregnancy/lactation;

- unwillingness to give informed consent and to enter a regular follow-up program.



Age minimum: 18 Years
Age maximum: 85 Years
Gender: All
Health Condition(s) or Problem(s) studied
Aortic Valve Disease
Athletes Heart
Coronary Artery Disease
Heart Failure
Hypertrophic Cardiomyopathy
Pulmonary Arterial Hypertension
Tetralogy of Fallot
Intervention(s)
Procedure: B-lines SE
Procedure: Coronary flow reserve SE
Procedure: Diastolic function SE
Procedure: Left ventricular contractile reserve SE
Procedure: Left ventricular outflow tract gradient SE
Procedure: Mitral regurgitation SE
Procedure: Pulmonary hemodynamics SE
Primary Outcome(s)
all cause death [Time Frame: 5 years]
cardiac death [Time Frame: 5 years]
transplantation [Time Frame: 5 years]
Secondary Outcome(s)
clinical (NYHA class IV) or functional (EF 30>10%) [Time Frame: 5 years]
Secondary ID(s)
FBF001
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Acibadem City Clinic, University Hospital,Sofia,Bulgaria
Careggi University Hospital, Florence, Italy
Elisabeth Hospital, Hodmezovasarhely, Hungary
Federico II University, Napoli, Italy
Hospital Clinics, Bari, Italy
Hospital Clinics, Trieste, Italy
Hospital de Clinicas de Porto Alegre - Universidade Federal do Rio Grande do Sul, Porto Alegre, Brasil
Hospital San José, Criciuma, Brasil
Hospital San Vicente de Paulo, Passo Fundo, Brasil
Institute of Clinical Physiology, CNR, Pisa,Italy
Investigaciones Medicas, Buenos Aires, Argentina
Medika Cardiocenter, Saint Petersburg, Russian Federation
Monaldi Hospital, Napoli, Italy
Ospedale dell'Angelo, Venezia-Mestre, Italy
Ospedale Nottola, Siena, Italy
Royal Brompton & Harefield NHS Foundation Trust
Salerno Hospital, Italy
San Carlo Public Hospital, Potenza, Italy
San Luca Hospital, Lucca, Italy
Sandro Pertini Hospital, Rome, Italy
Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian Federation
University of Belgrade,Serbia
University of Catania, Italy
University of Parma
University of Pisa, Italy
University of Szeged, Hungary
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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