Stress Echo 2020 - The International Stress Echo Study

Summary

Background: Stress echocardiography (SE) has an established role in evidence-based guidelines, but recently the breadth and variety of applications has extended well beyond coronary artery disease (CAD). Purpose: To establish a prospective research study of SE applications, in and beyond CAD, also considering a variety of signs in addition to regional wall motion abnormalities. Methods: In a prospective, multicenter, international, observational study design, \> 100 certified high-volume SE labs will be networked with an organized system of clinical, laboratory and imaging data collection at the time of physical or pharmacological SE, with structured follow-up information. The study is endorsed by the Italian Society of Echocardiography and organized in 10 subprojects focusing on: contractile reserve for prediction of cardiac resynchronization or medical therapy response; stress B-lines in heart failure; hypertrophic cardiomyopathy; heart failure with preserved ejection fraction; mitral regurgitation after either transcatheter or surgical aortic valve replacement; outdoor SE in extreme physiology; right ventricular contractile reserve in repaired tetralogy of Fallot; suspected or initial pulmonary arterial hypertension; coronary flow velocity, left ventricular elastance reserve and B-lines in known or suspected CAD; identification of subclinical familial disease in phenotype-negative healthy relatives of inherited disease (such as hypertrophic cardiomyopathy). Expected Results:To collect about 10,000 patients over a 5-year period (2016-2020), with sample sizes ranging from 5,000 for known or suspected CAD to around 250 for hypertrophic cardiomyopathy or repaired Fallot. This data base will allow to investigate technical questions such as feasibility and reproducibility of various SE parameters and to assess their prognostic value in different clinical scenarios. Conclusions: The study will create the cultural, informatic and scientific infrastructure connecting high-volume, accredited SE labs, to obtain original safety, feasibility, and outcome data in evidence-poor diagnostic fields, also outside the established core application of SE in CAD based on regional wall motion abnormalities. The study will standardize procedures, validate emerging signs, and integrate the new information with established knowledge, helping to build a next-generation SE lab without inner walls.

Conditions

• Coronary Artery Disease
• Heart Failure
• Hypertrophic Cardiomyopathy
• Aortic Valve Disease
• Athletes Heart
• Tetralogy of Fallot
• Pulmonary Arterial Hypertension

Interventions

PROCEDURE

Left ventricular contractile reserve SE

Stress protocols (either physical or pharmacological) will be performed according to recent guidelines recommendations (1,2,3). with special focus on Wall Motion Score Index.

PROCEDURE

B-lines SE

SE will be performed with special focus on lung sonography and B-lines score (3,4).B-lines will be scored with the 28-regions antero-lateral chest assessment as previously described at baseline and immediately after stopping exercise. A simplified 8-region scan is also allowed in order to save time without loss of critical information.

PROCEDURE

Left ventricular outflow tract gradient SE

SE will be performed with special focus on left ventricular outflow tract obstruction (3,4).

PROCEDURE

Diastolic function SE

SE will be performed with special focus on E/e', pulmonary artery systolic pressure, B-lines and left ventricular end-diastolic volume (3,4).

PROCEDURE

Mitral regurgitation SE

SE will be performed with special focus on mitral regurgitation and aortic valve gradients assessment (3,4).

PROCEDURE

Pulmonary hemodynamics SE

SE will be performed with special focus on pulmonary artery systolic pressure and pulmonary artery hemodynamics.

PROCEDURE

Coronary flow reserve SE

SE will be performed with special focus on regional wall motion + coronary artery flow velocity reserve.

Sponsors & Collaborators

• Institute of Clinical Physiology, CNR, Pisa,Italy

  collaborator UNKNOWN

• Salerno Hospital, Italy

  collaborator UNKNOWN

• Monaldi Hospital, Napoli, Italy

  collaborator UNKNOWN

• University of Pisa

  collaborator OTHER

• San Luca Hospital, Lucca, Italy

  collaborator UNKNOWN

• Careggi Hospital

  collaborator OTHER

• Federico II University

  collaborator OTHER

• San Carlo Public Hospital, Potenza, Italy

  collaborator OTHER

• Royal Brompton & Harefield NHS Foundation Trust

  collaborator OTHER

• Ospedale dell'Angelo, Venezia-Mestre

  collaborator OTHER

• University of Parma

  collaborator OTHER

• Hospital Clinics, Trieste, Italy

  collaborator UNKNOWN

• Federal University of Rio Grande do Sul

  collaborator OTHER

• Hospital San José, Criciuma, Brasil

  collaborator UNKNOWN

• Hospital San Vicente de Paulo, Passo Fundo, Brasil

  collaborator UNKNOWN

• University of Belgrade

  collaborator OTHER

• University of Szeged, Hungary

  collaborator UNKNOWN

• Elisabeth Hospital, Hodmezovasarhely, Hungary

  collaborator UNKNOWN

• Sandro Pertini Hospital, Rome, Italy

  collaborator UNKNOWN

• Hospital Clinics, Bari, Italy

  collaborator UNKNOWN

• Ospedale Nottola, Siena, Italy

  collaborator UNKNOWN

• University of Catania, Italy

  collaborator UNKNOWN

• Medika Cardiocenter, Saint Petersburg, Russian Federation

  collaborator UNKNOWN

• Acibadem City Clinic Tokuda Hospital

  collaborator OTHER

• Investigaciones Medicas, Buenos Aires, Argentina

  collaborator UNKNOWN

• Tomsk National Research Scientific Centre of Russian Academy of Sciences, Tomsk, Russian Federation

  collaborator UNKNOWN

• Instituto Nacional de Cardiología Mexico City, Mexico

  collaborator UNKNOWN

• Hamad Medical Corporation, Heart Hospital -Doha-Qatar

  collaborator UNKNOWN

• Fatebenefratelli Hospital

  lead OTHER

Principal Investigators

• Quirino Ciampi, MD · Fatebenefratelli Hospital

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2016-11-30

Primary Completion

2020-12-31

Completion

2021-12-31

Countries

• Italy

Study Locations