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

RecruitingOBSERVATIONAL
Enrollment

10,000

Participants

Timeline

Start Date

April 1, 2021

Primary Completion Date

December 31, 2022

Study Completion Date

December 31, 2030

Conditions
Coronary Artery DiseaseHeart FailureHypertrophic CardiomyopathyCongenital Heart DiseaseValvular Heart DiseasePost-chest Radio/ChemiotherapyHeart 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.

Trial Locations (1)

Unknown

RECRUITING

Fatebenefratelli Hospital, Benevento

Sponsors
All Listed Sponsors
collaborator

National Research Council, Institute of Clinical Physiology, Italy

OTHER

collaborator

Mayo Clinic

OTHER

collaborator

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

UNKNOWN

collaborator

Cardarelli Hospital, Naples, Italy

UNKNOWN

collaborator

Ospedale per gli Infermi, Faenza, Ravenna, Italy

UNKNOWN

collaborator

Institute of Family Medicine, University of Szeged, Hungary

UNKNOWN

collaborator

Montepulciano Hospital, Siena

UNKNOWN

collaborator

University of Pisa

OTHER

collaborator

University Hospital, Pleven, Bulgaria

UNKNOWN

collaborator

Tomsk National Research Medical Centre of the Russian

UNKNOWN

collaborator

University Hospital, Szeged, Hungary

UNKNOWN

collaborator

Elisabeth Hospital, Hódmezővásárhely, Hungary

UNKNOWN

collaborator

DASA, San Paolo, Brasil

UNKNOWN

collaborator

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

UNKNOWN

collaborator

University of A Coruna, La Coruna, Spain

UNKNOWN

collaborator

Antwerp University Hospital, Edegem, Belgium

UNKNOWN

collaborator

Università Luigi Vanvitelli della Campania

UNKNOWN

collaborator

Dolo Hospital, Venice, Italy

UNKNOWN

collaborator

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

UNKNOWN

collaborator

Investigaciones Medicas

UNKNOWN

collaborator

Bieganski Hospital, Medical University, Lodz, Poland

UNKNOWN

collaborator

Medical University of Silesia, Katowice, Poland

UNKNOWN

collaborator

Federal University of Paranà, Curitiba, Brasil

UNKNOWN

collaborator

Siriraj Hospital

OTHER

collaborator

Careggi Hospital

OTHER

collaborator

Instituto Nacional de Cardiologia Ignacio Chavez, Mexico City, Mexico

UNKNOWN

collaborator

Saint Petersburg State University Hospital, Russian Federation

UNKNOWN

collaborator

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

UNKNOWN

collaborator

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

UNKNOWN

collaborator

University Hospital, Padua, Italy

UNKNOWN

collaborator

Sant'Anna School of Advanced Study, Pisa

UNKNOWN

collaborator

University Hospital, Siena, Italy

UNKNOWN

collaborator

Vilnius University, Lithuania

UNKNOWN

collaborator

University of Parma

OTHER

collaborator

Universita di Verona

OTHER

collaborator

Malpighi Hospital, Bologna, Italy

UNKNOWN

collaborator

University of Modena and Reggio Emilia

OTHER

collaborator

Presidio Ospedale San Paolo. Milano

UNKNOWN

collaborator

IRCCS reggio emilia

UNKNOWN

collaborator

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

UNKNOWN

collaborator

University Hospital, Catania

OTHER

collaborator

Ospedale San Camillo, Rome, Italy

UNKNOWN

collaborator

University of Salerno

OTHER

collaborator

University of Algarve, Portugal.

UNKNOWN

collaborator

Heart Center, Hospital da Cruz Vermelha, Lisbon

UNKNOWN

collaborator

University of Bari

OTHER

collaborator

Hospital Motta di Livenza, Treviso

UNKNOWN

collaborator

Centro Cardiologico Monzino

OTHER

collaborator

Italian Society of Echocardiography and Cardiovascular Imaging

UNKNOWN

collaborator

San Luca Hospital, Lucca

UNKNOWN

collaborator

Hospital Sao José, Criciuma, Brasil

UNKNOWN

lead

Fatebenefratelli Hospital

OTHER

NCT05081115 - Stress Echo 2030: the Novel ABCDE-(FGLPR) Protocol to Define the Future of Imaging | Biotech Hunter | Biotech Hunter