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

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.

Conditions

• Coronary Artery Disease
• Heart Failure
• Hypertrophic Cardiomyopathy
• Congenital Heart Disease
• Valvular Heart Disease
• Post-chest Radio/Chemiotherapy
• Heart Transplantation

Interventions

DIAGNOSTIC_TEST

ABCDE-Stress Echo

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.

DIAGNOSTIC_TEST

SE diastolic assessment

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).

DIAGNOSTIC_TEST

SE Right ventricular function assessment

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.

DIAGNOSTIC_TEST

SE in heart donors

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.

Sponsors & Collaborators

• National Research Council, Institute of Clinical Physiology, Italy

  collaborator OTHER

• Mayo Clinic

  collaborator OTHER

• Hospital Sao Vicente de Paulo e Hospital de Cidade, Passo Fundo, Brasil

  collaborator UNKNOWN

• Cardarelli Hospital, Naples, Italy

  collaborator UNKNOWN

• Ospedale per gli Infermi, Faenza, Ravenna, Italy

  collaborator UNKNOWN

• Institute of Family Medicine, University of Szeged, Hungary

  collaborator UNKNOWN

• Montepulciano Hospital, Siena

  collaborator UNKNOWN

• University of Pisa

  collaborator OTHER

• University Hospital, Pleven, Bulgaria

  collaborator UNKNOWN

• Tomsk National Research Medical Centre of the Russian

  collaborator UNKNOWN

• University Hospital, Szeged, Hungary

  collaborator UNKNOWN

• Elisabeth Hospital, Hódmezővásárhely, Hungary

  collaborator UNKNOWN

• DASA, San Paolo, Brasil

  collaborator UNKNOWN

• University of Banja Luka University Clinical Centre of the Republic of Srpska

  collaborator UNKNOWN

• University of A Coruna, La Coruna, Spain

  collaborator UNKNOWN

• Antwerp University Hospital, Edegem, Belgium

  collaborator UNKNOWN

• Università Luigi Vanvitelli della Campania

  collaborator UNKNOWN

• Dolo Hospital, Venice, Italy

  collaborator UNKNOWN

• Institute for Cardiovascular Diseases Dedinje, School of Medicine, Belgrade, Serbia

  collaborator UNKNOWN

• Investigaciones Medicas

  collaborator UNKNOWN

• Bieganski Hospital, Medical University, Lodz, Poland

  collaborator UNKNOWN

• Medical University of Silesia, Katowice, Poland

  collaborator UNKNOWN

• Federal University of Paranà, Curitiba, Brasil

  collaborator UNKNOWN

• Siriraj Hospital

  collaborator OTHER

• Careggi Hospital

  collaborator OTHER

• Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico

  collaborator UNKNOWN

• Saint Petersburg State University Hospital, Russian Federation

  collaborator UNKNOWN

• Clinical Hospital Zvezdara, Medical School, University of Belgrade, Serbia

  collaborator UNKNOWN

• University Center Serbia, Medical School, University of Belgrade, Serbia

  collaborator UNKNOWN

• University Hospital, Padua, Italy

  collaborator UNKNOWN

• Sant'Anna School of Advanced Study, Pisa

  collaborator UNKNOWN

• University Hospital, Siena, Italy

  collaborator UNKNOWN

• Vilnius University, Lithuania

  collaborator UNKNOWN

• University of Parma

  collaborator OTHER

• Universita di Verona

  collaborator OTHER

• Malpighi Hospital, Bologna, Italy

  collaborator UNKNOWN

• University of Modena and Reggio Emilia

  collaborator OTHER

• Presidio Ospedale San Paolo. Milano

  collaborator UNKNOWN

• IRCCS reggio emilia

  collaborator UNKNOWN

• Association for Public Health "Salute Pubblica", Brindisi, Italy

  collaborator UNKNOWN

• University Hospital, Catania

  collaborator OTHER

• Ospedale San Camillo, Rome, Italy

  collaborator UNKNOWN

• University of Salerno

  collaborator OTHER

• University of Algarve, Portugal.

  collaborator UNKNOWN

• Heart Center, Hospital da Cruz Vermelha, Lisbon

  collaborator UNKNOWN

• University of Bari

  collaborator OTHER

• Hospital Motta di Livenza, Treviso

  collaborator UNKNOWN

• Centro Cardiologico Monzino

  collaborator OTHER

• Italian Society of Echocardiography and Cardiovascular Imaging

  collaborator UNKNOWN

• San Luca Hospital, Lucca

  collaborator UNKNOWN

• Hospital Sao José, Criciuma, Brasil

  collaborator UNKNOWN

• Fatebenefratelli Hospital

  lead OTHER

Eligibility

Min Age

18 Years

Max Age

75 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-04-01

Primary Completion

2022-12-31

Completion

2030-12-31

Countries

• Italy

Study Locations