About this trial
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
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
None
Trial population
The various projects will include patients with known or suspected CAD (project 1), known or suspected heart failure with preserved ejection fraction (project 2), hypertrophic cardiomyopathy (HCM, project 3), status post-chest radiotherapy and chemotherapy (project 4), repaired Tetralogy of Fallot (project 7), cardio-pulmonary involvement post-COVID 19 (project 8), post-ischemic (project 10) and primary valvular heart disease (project 11) and suspected coronary vasospasm, a diagnosis frequently missed but important to recognize as a possible cause of life-threatening disease, which is easy to treat when promptly identified (project 12).
Trial design
Case-only
Prospective
Treatments tested in this trial
ABCDE-Stress Echo
Diagnostic testEach laboratory will adopt the preferred Echo stress among physical pharmacologic or pacing stress according to guidelines recommendations. Pharmacologic testing will be with dobutamine or vasodilators (dipyridamole, adenosine or regadenoson) according to physician preferences, patients' contraindications, local availability and cost. Pacing stress can be performed with transesophageal or with external permanent pacemaker. A standardized format with the ABCDE protocol will be followedl. Step D is easy with vasodilator, less easy with dobutamine, not easy and less feasible - impossible with (peak or post) treadmill exercise. Our recommendation is to use semi-supine exercise, capturing coronary flow signal in early or intermediate stages when most flow increases and feasibility is still high. When treadmill is used, step D is skipped; if information is deemed important, a vasodilator test can be performed at 30' after the end of exercise focused on CFVR and heart rate response.
SE diastolic assessment
Diagnostic testThe diastolic assessment should be included into all exercise SE tests by measuring standard Doppler-derived mitral inflow velocity, pulsed Tissue Doppler of mitral annulus, and retrograde tricuspid gradient of tricuspid regurgitation, at intermediate load of exercise and/or 1- 2 min after the end of the exercise. We will also assess, at baseline, intermediate load (50 watts) and peak-post stress: end-diastolic left ventricular volume index; end-systolic left ventricular volume index; ejection fraction and both stroke volume and cardiac output (to assess conventional contractile reserve); mitral regurgitation and left ventricular outflow tract obstruction; pulmonary artery systolic pressure; B-lines; right ventricular free wall strain to assess the presence of right ventricular dysfunction; left atrial volume index; peak atrial longitudinal strain; and mitral inflow E velocity and mitral annulus e' tissue Doppler velocity; global longitudinal strain (GLS).
SE Right ventricular function assessment
Diagnostic testRight ventricular function will be assessed at baseline and peak stress with variations of tricuspid annular plane systolic excursion, an index of right ventricular longitudinal function, and right ventricular fractional area change (a load-dependent index of right ventricular inlet function). To distinguish between genuine right ventricular dysfunction and/or pathological increases in pulmonary vascular load, we will combine systolic pulmonary artery pressure and right ventricular end-systolic area to calculate right ventricular end-systolic pressure-area relation. Peak systolic tricuspid annulus velocity and conventional indices of left ventricular systolic and diastolic function will also be measured at baseline and peak stress according to the standard ABCDE-FGLPR protocol. Right ventricular free wall strain combined with interventricular septum strain will be assessed. Left ventricular function, wall motion score index and E/e' at baseline and peak stress.
SE in heart donors
Diagnostic testThe examination of the heart starts with a resting transthoracic echocardiography. Exclusion criteria are: resting wall motion score index\>1.0; ejection fraction \<45%; diastolic dysfunction of grade 2 or more; hemodynamically significant (moderate or higher) valve regurgitation or stenosis; severe left ventricular hypertrophy (left ventricular mass index \>175 g/m2). A pharmacological SE with dipyridamole (0.84 mg/kg over 6 minutes) is recommended. The diagnostic end-points are stress-induced RWMA and abnormalities in global LVCR. All images will be analyzed as per guidelines similarly to the other projects, with emphasis on wall motion score index and LVCR based on ejection fraction and force. The hearts excluded from donation for RWMA or abnormal LVCR could however be collected for heart valve preparation and evaluated by coronary angiography and by pathological examination according to local facilities.
Treatment groups
12
Treatment groupsSee each treatment group below.
Trial outcomes
Primary outcomes
All cause death
Death from any cause occurring between 5 years after the time of SE enrollment
Cardiac death
Death from cardiac cause occurring between 5 years after the time of SE enrollment
Diagnosis of Cancer
Diagnosis of cancer of any type occurring between 5 years after the time of SE enrollment
Secondary outcomes
Diagnosis of Acute Myocardial Infarction
Diagnosi of hospitalization for acute Myocardial infarction occurring between 5 years after the time of SE enrollment
Implantable Cardioverter defibrillator implantation
Implantable Cardioverter defibrillator implantation date occurring between 5 years after the time of SE enrollment
Coronary percutaneous revascolarization
Coronary percutaneous revascolarization date occurring between 5 years after the time of SE enrollment
CABG surgery
CABG surgery date occurring between 5 years after the time of SE enrollment
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Fatebenefratelli Hospital
Lead sponsor
National Research Council, Institute of Clinical Physiology, Italy
Collaborator
Mayo Clinic
Collaborator
Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil
Collaborator
Cardarelli Hospital, Naples, Italy
Collaborator
Ospedale per gli Infermi, Faenza, Ravenna, Italy
Collaborator
Institute of Family Medicine, University of Szeged, Hungary
Collaborator
Montepulciano Hospital, Siena
Collaborator
University of Pisa
Collaborator
University Hospital, Pleven, Bulgaria
Collaborator
Tomsk National Research Medical Centre of the Russian
Collaborator
University Hospital, Szeged, Hungary
Collaborator
Elisabeth Hospital, Hódmezővásárhely, Hungary
Collaborator
DASA, San Paolo, Brasil
Collaborator
University Clinical Centre of Republic of Srpska
Collaborator
University of A Coruna, La Coruna, Spain
Collaborator
Antwerp University Hospital, Edegem, Belgium
Collaborator
University of Campania Luigi Vanvitelli
Collaborator
Dolo Hospital, Venice, Italy
Collaborator
Institute for Cardiovascular Diseases Dedinje, School of Medicine, Belgrade, Serbia
Collaborator
Investigaciones Medicas
Collaborator
Bieganski Hospital, Medical University, Lodz, Poland
Collaborator
Medical University of Silesia, Katowice, Poland
Collaborator
Federal University of Paranà, Curitiba, Brasil
Collaborator
Siriraj Hospital
Collaborator
Careggi Hospital
Collaborator
Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico
Collaborator
Saint Petersburg State University Hospital, Russian Federation
Collaborator
Clinical Hospital Zvezdara, Medical School, University of Belgrade, Serbia
Collaborator
University Center Serbia, Medical School, University of Belgrade, Serbia
Collaborator
University Hospital, Padua, Italy
Collaborator
Sant'Anna School of Advanced Study, Pisa
Collaborator
University Hospital, Siena, Italy
Collaborator
Vilnius University, Lithuania
Collaborator
University of Parma
Collaborator
Universita di Verona
Collaborator
Malpighi Hospital, Bologna, Italy
Collaborator
University of Modena and Reggio Emilia
Collaborator
Presidio Ospedale San Paolo. Milano
Collaborator
IRCCS reggio emilia
Collaborator
Association for Public Health "Salute Pubblica", Brindisi, Italy
Collaborator
University Hospital, Catania
Collaborator
Ospedale San Camillo, Rome, Italy
Collaborator
University of Salerno
Collaborator
University of Algarve, Portugal.
Collaborator
Heart Center, Hospital da Cruz Vermelha, Lisbon
Collaborator
University of Bari
Collaborator
Hospital Motta di Livenza, Treviso
Collaborator
Centro Cardiologico Monzino
Collaborator
Italian Society of Echocardiography and Cardiovascular Imaging
Collaborator
San Luca Hospital, Lucca
Collaborator
Hospital Sao José, Criciuma, Brasil
Collaborator