The International Stress Echo Study to to Define the Future of Imaging
Trial ID: NCT05081115
Status: RECRUITING
Study type: OBSERVATIONAL
Start date: 2021-04-01
Completion date: 2030-12-31
Sponsor: Fatebenefratelli Hospital
Collaborators: National Research Council, Institute of Clinical Physiology, Italy; Mayo Clinic; Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil; Cardarelli Hospital, Naples, Italy; Ospedale per gli Infermi, Faenza, Ravenna, Italy; Institute of Family Medicine, University of Szeged, Hungary; Montepulciano Hospital, Siena; University of Pisa; University Hospital, Pleven, Bulgaria; Tomsk National Research Medical Centre of the Russian; University Hospital, Szeged, Hungary; Elisabeth Hospital, Hódmezővásárhely, Hungary; DASA, San Paolo, Brasil; University Clinical Centre of Republic of Srpska; University of A Coruna, La Coruna, Spain; Antwerp University Hospital, Edegem, Belgium; University of Campania Luigi Vanvitelli; Dolo Hospital, Venice, Italy; Institute for Cardiovascular Diseases Dedinje, School of Medicine, Belgrade, Serbia; Investigaciones Medicas; Bieganski Hospital, Medical University, Lodz, Poland; Medical University of Silesia, Katowice, Poland; Federal University of Paranà, Curitiba, Brasil; Siriraj Hospital; Careggi Hospital; Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico; Saint Petersburg State University Hospital, Russian Federation; Clinical Hospital Zvezdara, Medical School, University of Belgrade, Serbia; University Center Serbia, Medical School, University of Belgrade, Serbia; University Hospital, Padua, Italy; Sant'Anna School of Advanced Study, Pisa; University Hospital, Siena, Italy; Vilnius University, Lithuania; University of Parma; Universita di Verona; Malpighi Hospital, Bologna, Italy; University of Modena and Reggio Emilia; Presidio Ospedale San Paolo. Milano; IRCCS reggio emilia; Association for Public Health "Salute Pubblica", Brindisi, Italy; University Hospital, Catania; Ospedale San Camillo, Rome, Italy; University of Salerno; University of Algarve, Portugal.; Heart Center, Hospital da Cruz Vermelha, Lisbon; University of Bari; Hospital Motta di Livenza, Treviso; Centro Cardiologico Monzino; Italian Society of Echocardiography and Cardiovascular Imaging; San Luca Hospital, Lucca; Hospital Sao José, Criciuma, Brasil
Conditions: Coronary Artery Disease; Heart Failure; Hypertrophic Cardiomyopathy; Congenital Heart Disease; Valvular Heart Disease; Post-chest Radio/Chemiotherapy; Heart Transplantation
Interventions: ABCDE-Stress Echo; SE diastolic assessment; SE Right ventricular function assessment; SE in heart donors
Locations: Fatebenefratelli Hospital
Countries: Italy
Enrollment: 10000
Age range: 18 Years - 75 Years
Sex: ALL

Summary:
With stress echo (SE) 2020 study, a new standard of practice in stress imaging was developed and disseminated: the ABCDE protocol for functional testing within and beyond CAD. ABCDE protocol was the fruit of SE 2020, and is the seed of SE 2030, which is articulated in 12 projects: 1-SE in coronary artery disease (SECAD); 2- SE in diastolic heart failure (SEDIA); 3-SE in hypertrophic cardiomyopathy (SEHCA); 4- SE post-chest radiotherapy and chemotherapy (SERA); 5- Artificial intelligence SE evaluation (AI-SEE); 6- Environmental stress echocardiography and air pollution (ESTER); 7- SE in repaired Tetralogy of Fallot (SETOF) ; 8- SE in post-COVID-19 (SECOV); 9: Recovery by stress echo of conventionally unfit donor good hearts (RESURGE); 10- SE for mitral ischemic regurgitation (SEMIR); 11- SE in valvular heart disease (SEVA); 12- SE for coronary vasospasm (SESPASM). The study aims to recruit in the next 5 years (2021-2025) ≥10 000 patients followed for ≥5 years (up to 2030) from ≥20 quality-controlled laboratories from ≥10 countries. In this COVID-19 era of sustainable health care delivery, SE2030 will provide the evidence to finally recommend SE as the optimal and versatile imaging modality for functional testing anywhere, any time and in any patient.

Eligibility criteria:
Inclusion Criteria:

Known or suspected coronary artery disease Hypertrofic cardiomiopathy Repaired Tetralogy of Fallot Primary valvular disease

Exclusion Criteria:

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Outcomes:
All cause death; Cardiac death; Diagnosis of Cancer