Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFatebenefratelli Hospital

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 volunteers

Qualifiers

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

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

  • ABCDE-Stress Echo

    Diagnostic test

    Each 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 test

    The 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 test

    Right 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 test

    The 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

10,000 Participants
are divided into 12 treatment groups

12

Treatment groups

See each treatment group below.

Group A: ABCDE-Stress Echo in Coronary Artery Disease (SECAD project)1 intervention
Group B: ABCDE-Stress Echo in Diastolic Heart failure (SEDIA project)2 interventions
Group C: ABCDE-Stress Echo in Hypertrophic Cardiomyopathy (SEHCA project)2 interventions
Group D: ABCDE-Stress Echo post-Radiotherapy (SERA project)2 interventions
Group E: ABCDE- Artificial Intelligence Stress echo (AI-SEE)3 interventions
Group F: ABCDE- Environmental Stress Echocardiography, air pollution and medical radiation (ESTER project)3 interventions
Group G: SETOF Stress Echo in operated Tetralogy of Fallot.3 interventions
Group H: Stress Echo for surveillance post-COVID-19 (SECOV).3 interventions
Group I: RESURGE: Recovery by stress echo of conventionally unfit donor good hearts.2 interventions
Group J: SEMIR- Stress echo in ischemic mitral regurgitation3 interventions
Group K: SEVA: Stress Echocardiography in Valvular Heart Disease3 interventions
Group L: SESPASM - SE for coronary vasospasm2 interventions

Trial outcomes

Primary outcomes

1

All cause death

Death from any cause occurring between 5 years after the time of SE enrollment

Time frame
5 years
2

Cardiac death

Death from cardiac cause occurring between 5 years after the time of SE enrollment

Time frame
5 years
3

Diagnosis of Cancer

Diagnosis of cancer of any type occurring between 5 years after the time of SE enrollment

Time frame
5 years

Secondary outcomes

1

Diagnosis of Acute Myocardial Infarction

Diagnosi of hospitalization for acute Myocardial infarction occurring between 5 years after the time of SE enrollment

Time frame
5 years
2

Implantable Cardioverter defibrillator implantation

Implantable Cardioverter defibrillator implantation date occurring between 5 years after the time of SE enrollment

Time frame
5 years
3

Coronary percutaneous revascolarization

Coronary percutaneous revascolarization date occurring between 5 years after the time of SE enrollment

Time frame
5 years
4

CABG surgery

CABG surgery date occurring between 5 years after the time of SE enrollment

Time frame
5 years

Other outcomes

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