Clinical trial NCT04509674: EMPACT-MI: A Study to Test Whether Empagliflozin Can Lower the Risk of Heart Failure and Death in People Who Had a Heart Attack (Myocardial Infarction)
Official title: EMPACT-MI: A Streamlined, Multicentre, Randomised, Parallel Group, Double-blind Placebo-controlled Superiority Trial to Evaluate the Effect of EMPAgliflozin on Hospitalisation for Heart Failure and Mortality in Patients With aCuTe Myocardial Infarction
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Myocardial Infarction
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
Collaborators: name: Eli Lilly and Company
First posted: 2020-08-12
Enrollment: 6522
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a study in adults who had a heart attack (myocardial infarction). The purpose of this study is to find out whether a medicine called empagliflozin helps to lower the chances of having to go to the hospital for heart failure and whether it lowers the chances of dying from cardiovascular disease.

People who are in hospital may join the study soon after being treated for their heart attack. Participants are put into 2 groups by chance. One group takes 1 empagliflozin tablet a day. The other group takes 1 placebo tablet a day. Placebo tablets look like empagliflozin tablets but do not contain any medicine. All participants continue their standard treatment. Empagliflozin belongs to a class of medicines known as SGLT-2 inhibitors. Empagliflozin is a medicine that helps people with type 2 diabetes to lower their blood sugar. Researchers think that empagliflozin might also help people after heart attack who are at risk for heart failure, whether or not they have diabetes.

Participants are in the study for about 1 to 2 years. During this time, there are about 4 visits inperson, 2 visits are done either by phone or by use of an mobile application. Results between the empagliflozin and placebo groups are compared. The doctors also regularly check the general health of the participants.


Eligibility criteria: Inclusion Criteria:

1. Of full age of consent (according to local legislation, at least ≥ 18 years) at screening.
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.
3. Male or female patients. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. A list of contraception methods meeting these criteria is provided in the patient information.
4. Diagnosis of spontaneous Acute Myocardial Infarction (AMI): ST-Elevation Myocardial Infarction (STEMI) or Non-ST Elevation Myocardial Infarction (NSTEMI) with randomisation to occur no later than 14 calendar days after hospital admission. For patients with an in-hospital Myocardial Infarction (MI) as qualifying event, randomization must still occur within 14 days of hospital admission.
5. High risk of HF, defined as EITHER

   1. Symptoms (e.g. dyspnea; decreased exercise tolerance; fatigue), or signs of congestion (e.g. pulmonary rales, crackles or crepitations; elevated jugular venous pressure; congestion on chest X-ray), that require treatment (e.g. augmentation or initiation of oral diuretic therapy; i.v. diuretic therapy; i.v. vasoactive agent; mechanical intervention etc.) at any time during the hospitalization.

      OR
   2. Newly developed Left Ventricular Ejection Fraction (LVEF) \< 45% as measured by echocardiography, ventriculography, cardiac Computer Tomography (CT), Magnetic Resonance Imaging (MRI) or radionuclide imaging during index hospitalisation.
6. In addition at least one of the following risk factors:

   * Age \> 65 years,
   * Newly developed LVEF \< 35%,
   * Prior MI (before index MI) documented in medical records,
   * Estimated Glomerular Filtration Rate (eGFR) \< 60 ml/min/1.73m2 (using Chronic Kidney Disease Epidemiology Collaboration Equation (CKD-EPI) formula based on creatinine from local lab at any time during index hospitalisation),
   * Atrial fibrillation (persistent or permanent ; if paroxysmal, only valid if associated with index MI),
   * Type 2 diabetes mellitus (prior or new diagnosis),
   * N-Terminal Pro-Brain Natriuretic Peptide (NT-proBNP) \>1,400 pg/mL for patients in sinus rhythm, \>2,800 pg/mL if atrial fibrillation; Brain Natriuretic Peptide (BNP) \>350 pg/mL for patients in sinus rhythm, \>700 pg/mL if atrial fibrillation, measured at any time during hospitalisation,
   * Uric acid \>7.5 mg/dL (\>446 μmol/L), measured at any time during hospitalisation,
   * Pulmonary Artery Systolic Pressure \[or right ventricular systolic pressure\] \>40 mmHg (non-invasive \[usually obtained from clinically indicated post-MI echocardiography\] or invasive, at any time during hospitalisation),
   * Patient not revascularized (and no planned revascularization) for the index MI (Includes e.g. patients where no angiography is performed, unsuccessful revascularization attempts, diffuse atherosclerosis not amenable for intervention; but does NOT include if revascularization was not performed due to nonobstructive coronary arteries),
   * 3-vessel coronary artery disease at time of index MI,
   * Diagnosis of peripheral artery disease (extracoronary vascular disease, e.g. lower extremity artery disease or carotid artery disease).

Exclusion Criteria:

1. Diagnosis of chronic Heart Failure (HF) prior to index MI.
2. Systolic blood pressure \< 90 mmHg at randomisation.
3. Cardiogenic shock or use of i.v. inotropes in last 24 hours before randomisation.
4. Coronary Artery Bypass Grafting planned at time of randomisation.
5. Current diagnosis of Takotsubo cardiomyopathy.
6. Any current severe (stenotic or regurgitant) valvular heart disease.
7. eGFR \< 20 ml/min/1.73m2 (using CKD-EPI formula based on most recent creatinine from local lab during index hospitalisation) or on dialysis.
8. Type I diabetes mellitus. Further exclusion criteria apply.

Primary outcomes:
measure: Composite of Time to First Heart Failure Hospitalisation or All-cause Mortality
timeFrame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
Secondary outcomes:
measure: Key Secondary Endpoint - Total Number of Hospitalisations for Heart Failure (HHF) or All-cause Mortality
timeFrame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
measure: Key Secondary Endpoint - Total Number of Non-elective Cardiovascular (CV) Hospitalisations or All-cause Mortality
timeFrame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
measure: Key Secondary Endpoint - Total Number of Non-elective All-cause Hospitalisations or All-cause Mortality
timeFrame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
measure: Key Secondary Endpoint - Total Number of Hospitalisations for Myocardial Infarction (MI) or All-cause Mortality
timeFrame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
measure: Time to Cardiovascular (CV) Mortality
timeFrame: From randomisation or first study drug administration (if randomisation occurred after first drug administration), until individual day of trial completion. Up to 1004 days.
Other outcomes:
Locations:
city: Alexander City
country: United States
facility: Advanced Cardiovascular LLC
state: Alabama
city: Birmingham
country: United States
facility: Grandview Medical Center
state: Alabama
city: Huntsville
country: United States
facility: Heart Center Research, LLC
state: Alabama
city: Gilbert
country: United States
facility: Mercy Gilbert Medical Center
state: Arizona
city: Little Rock
country: United States
facility: Arkansas Cardiology, PA
state: Arkansas
city: Bakersfield
country: United States
facility: Comprehensive Cardiovascular Medical Group
state: California
city: Covina
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Long Beach
country: United States
facility: Cardiovascular Innovation and Research Center
state: California
city: Los Angeles
country: United States
facility: University of California Los Angeles
state: California
city: Mission Hills
country: United States
facility: InvivoCure
state: California
city: Northridge
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: Pasadena
country: United States
facility: Valley Clinical Trials, Inc.
state: California
city: San Diego
country: United States
facility: Kaiser Permanente
state: California
city: San Diego
country: United States
facility: San Diego Cardiac Center
state: California
city: Torrance
country: United States
facility: The Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center
state: California
city: West Hills
country: United States
facility: Interventional Cardiology Medical Group
state: California
city: Washington
country: United States
facility: George Washington University Medical Faculty Associates
state: District of Columbia
city: Clearwater
country: United States
facility: Clearwater Cardiovascular Consultants
state: Florida
city: Fort Lauderdale
country: United States
facility: Integrative Research Associates
state: Florida
city: Jacksonville
country: United States
facility: University of Florida Health Jacksonville
state: Florida
city: Palm Beach Gardens
country: United States
facility: Cardiology Partners Clinical Research Institute
state: Florida
city: Port Charlotte
country: United States
facility: Charlotte Heart Group Research Center
state: Florida
city: Atlanta
country: United States
facility: Grady Memorial Hospital
state: Georgia
city: Thomasville
country: United States
facility: Cardiovascular Consultants of South Georgia, LLC
state: Georgia
city: Tucker
country: United States
facility: Atlanta Heart Specialists, LLC
state: Georgia
city: Fairview Heights
country: United States
facility: Advanced Heart Care, LLC, Medicoricum, LLC
state: Illinois
city: Elkhart
country: United States
facility: Midwest Cardiovascular Research and Education Foundation
state: Indiana
city: Munster
country: United States
facility: Cardiovascular Research of Northwest Indiana, LLC
state: Indiana
city: Richmond
country: United States
facility: Reid Physician Associates
state: Indiana
city: Overland Park
country: United States
facility: Midwest Heart and Vascular Specialists
state: Kansas
city: Lexington
country: United States
facility: University of Kentucky Medical Center
state: Kentucky
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Bangor
country: United States
facility: Eastern Maine Medical Center
state: Maine
city: Columbia
country: United States
facility: Cardiovascular Specialists of Central Maryland
state: Maryland
city: Rockville
country: United States
facility: Shady Grove Adventist Hospital
state: Maryland
city: Grand Rapids
country: United States
facility: Healthy Heart Cardiology
state: Michigan
city: Kalamazoo
country: United States
facility: Western Michigan University
state: Michigan
city: Midland
country: United States
facility: Mid Michigan Medical Center
state: Michigan
city: Ypsilanti
country: United States
facility: Michigan Heart, PC
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Tupelo
country: United States
facility: Cardiology Associates Research, LLC
state: Mississippi
city: Columbia
country: United States
facility: Missouri Cardiovascular Specialists, LLP
state: Missouri
city: Columbia
country: United States
facility: University of Missouri Health System
state: Missouri
city: North Kansas City
country: United States
facility: North Kansas City Hospital
state: Missouri
city: Saint Louis
country: United States
facility: Gateway Cardiology, PC
state: Missouri
city: Saint Louis
country: United States
facility: St. Louis Heart and Vascular, P.C.
state: Missouri
city: Hackensack
country: United States
facility: Holy Name Medical Center
state: New Jersey
city: Pomona
country: United States
facility: AtlantiCare
state: New Jersey
city: Vineland
country: United States
facility: The Heart House
state: New Jersey
city: Liverpool
country: United States
facility: SJH Cardiology Associates
state: New York
city: Stony Brook
country: United States
facility: Stony Brook University Hospital
state: New York
city: Asheville
country: United States
facility: Asheville Cardiology Associates
state: North Carolina
city: Chapel Hill
country: United States
facility: The University of North Carolina at Chapel Hill
state: North Carolina
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
city: Greensboro
country: United States
facility: Moses H. Cone Memorial Hospital
state: North Carolina
city: Greensboro
country: United States
facility: Medication Management, LLC
state: North Carolina
city: Raleigh
country: United States
facility: North Carolina Heart and Vascular
state: North Carolina
city: Minot
country: United States
facility: Trinity Health Center Medical Arts
state: North Dakota
city: Canton
country: United States
facility: Aultman Hospital
state: Ohio
city: Cincinnati
country: United States
facility: Cincinnati VA Medical Center
state: Ohio
city: Kettering
country: United States
facility: Kettering Medical Center
state: Ohio
city: Oklahoma City
country: United States
facility: Oklahoma Heart Hospital Research Foundation, Incorporated
state: Oklahoma
city: Oklahoma City
country: United States
facility: South Oklahoma Heart Research Group
state: Oklahoma
city: Camp Hill
country: United States
facility: Capital Area Research, LLC
state: Pennsylvania
city: Philadelphia
country: United States
facility: Penn Presbyterian Medical Center
state: Pennsylvania
city: Sayre
country: United States
facility: Guthrie Medical Group PC
state: Pennsylvania
city: Greenville
country: United States
facility: Upstate Cardiology, PA
state: South Carolina
city: Lancaster
country: United States
facility: Carolina Heart Specialists, LLC
state: South Carolina
city: Rapid City
country: United States
facility: Monument Health
state: South Dakota
city: Nashville
country: United States
facility: Centennial Heart Cardiovascular Consultants, LLC
state: Tennessee
city: Oak Ridge
country: United States
facility: Parkway Cardiology Associates
state: Tennessee
city: Powell
country: United States
facility: Cardiovascular Research of Knoxville
state: Tennessee
city: Allen
country: United States
facility: Texas Health Presbyterian Hospital Allen
state: Texas
city: Amarillo
country: United States
facility: Amarillo Heart Clinical Research Institute, Incorporated
state: Texas
city: Amarillo
country: United States
facility: Pharmatex Research
state: Texas
city: Dallas
country: United States
facility: Dallas VA Medical Center
state: Texas
city: Plano
country: United States
facility: Baylor Scott and White Health
state: Texas
city: San Antonio
country: United States
facility: South Texas Cardiovascular Consultants
state: Texas
city: Sherman
country: United States
facility: Revival Research Institute, LLC.
state: Texas
city: Tyler
country: United States
facility: Cardiovascular Associates of East Texas, PA
state: Texas
city: Manassas
country: United States
facility: Carient Heart and Vascular
state: Virginia
city: Newport News
country: United States
facility: Riverside Regional Medical Center
state: Virginia
city: Newport News
country: United States
facility: Tidewater Physicians Multispecialty Group
state: Virginia
city: Norfolk
country: United States
facility: Sentara Hospitals
state: Virginia
city: Roanoke
country: United States
facility: Roanoke Heart Institute PLC
state: Virginia
city: Belgrano
country: Argentina
facility: Instituto Cardiovascular de Buenos Aires
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Fundacion Sanatorio Güemes
city: Cordoba
country: Argentina
facility: Hospital Italiano de Córdoba
city: Cordoba
country: Argentina
facility: Sanatorio Allende
city: Cordoba
country: Argentina
facility: Centro Medico Luquez
city: Cordoba
country: Argentina
facility: Hospital Privado Centro Medico de Cordoba
city: Cordoba
country: Argentina
facility: Clinica Privada del Prado
city: Coronel Suarez
country: Argentina
facility: Centro de Investigacion Clinica Coronel Suarez
city: Corrientes
country: Argentina
facility: Instituto de Cardiologia de Corrientes
city: Monserrat
country: Argentina
facility: Fundación Favaloro para la Docencia e Investigación Medica
city: Quilmes
country: Argentina
facility: Sanatorio Modelo de Quilmes
city: Rosario
country: Argentina
facility: Instituto Cardiovascular de Rosario
city: Rosario
country: Argentina
facility: Sanatorio Delta
city: Rosario
country: Argentina
facility: Sanatorio Parque
city: San Martin
country: Argentina
facility: Corporacion Medica de Gral. San Martin S.A.
city: San Miguel de Tucuman
country: Argentina
facility: Centro Privado de Cardiologia
city: San Nicolas
country: Argentina
facility: Clinica U.O.M.
city: Santa Fe
country: Argentina
facility: Sanatorio Diagnóstico
city: Santa Fé
country: Argentina
facility: Hospital "Dr. José Maria Cullen"
city: Villa Maria
country: Argentina
facility: Clinica Privada Fusavim SRL
city: Concord
country: Australia
facility: Concord Repatriation General Hospital
state: New South Wales
city: Liverpool
country: Australia
facility: South Western Sydney Local Health District
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital
state: New South Wales
city: Westmead
country: Australia
facility: Westmead Hospital
state: New South Wales
city: Chermside
country: Australia
facility: The Prince Charles Hospital
state: Queensland
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Southport
country: Australia
facility: Gold Coast University Hospital
state: Queensland
city: Melbourne
country: Australia
facility: Alfred Hospital
state: Victoria
city: Aracaju - SE
country: Brazil
facility: JMF Clinica Do Coracao LTDA
city: Balneario Camboriu
country: Brazil
facility: Hospital Santa Isabel
city: Belo Horizonte
country: Brazil
facility: Hospital Madre Teresa
city: Brasilia
country: Brazil
facility: Hospital do Coracao do Brasil
city: Campina Grande do Sul
country: Brazil
facility: Hospital Angelina Caron
city: Campinas
country: Brazil
facility: Centro Especializado em Cardiol Loema Instituto de Pesq Clin
city: Campinas
country: Brazil
facility: IPECC - Instituto de Pesquisa Clínica de Campinas
city: Fortaleza
country: Brazil
facility: Hospital de Messejana Dr. Carlos Alberto Studart Gomes
city: Goiania
country: Brazil
facility: HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
city: Joinville
country: Brazil
facility: Hospital Regional Hans Dieter Schmidt
city: Marília
country: Brazil
facility: Santa Casa de Misericórdia de Marília
city: Passo Fundo
country: Brazil
facility: Hospital São Vicente de Paulo
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas da PUCRS
city: Porto Alegre
country: Brazil
facility: Instituto de Cardiologia Rio Grande do Sul
city: Porto Alegre
country: Brazil
facility: Hospital Nossa Senhora da Conceição
city: Recife
country: Brazil
facility: Hospital Agamenon Magalhaes
city: Ribeirao Preto
country: Brazil
facility: Fundacao de apoio ao ensino e assitencia HCFMRP
city: Rio de Janeiro
country: Brazil
facility: Hospital Copa D'or
city: Salvador
country: Brazil
facility: Instituto de Ensino E Pesquisa Do Hospital Da Bahia
city: Sao Jose do Rio Preto
country: Brazil
facility: Hospital de Base - Fac Med de Sao Jose do Rio Preto
city: Sao Paulo
country: Brazil
facility: Hospital Samaritano
city: Sao Paulo
country: Brazil
facility: Hospital Sao Luiz Jabaquara
city: Sao Paulo
country: Brazil
facility: Hospital Sao Luiz Morumbi
city: Sao Paulo
country: Brazil
facility: Hospital das Clínicas de Sao Paulo - INCOR
city: São Bernardo do Campo
country: Brazil
facility: CEMEC - Centro Multidisciplinar de Estudos Clínicos
city: Votuporanga
country: Brazil
facility: Santa Casa de Votuporanga
city: Blagoevgrad
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment Pulse AD
city: Gabrovo
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment "Dr. Tota Venkova" AD
city: Haskovo
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment AD Haskovo
city: Pazardzhik
country: Bulgaria
facility: Multiprofile Hospital For Active Treatment - Pazardzhik AD
city: Pernik
country: Bulgaria
facility: Specialized Hospital for Active Treatment Sv. Georgi - Pernik
city: Pleven
country: Bulgaria
facility: Medical Center Medconsult Pleven LTD
city: Pleven
country: Bulgaria
facility: Multiprofile Hospital for Active Treatment Heart and Brain EAD
city: Pleven
country: Bulgaria
facility: SHAT in Cardiology EAD, Pleven
city: Plovdiv
country: Bulgaria
facility: Hospital MHAT Plovdiv, AD
city: Sofia
country: Bulgaria
facility: National Heart Hospital, Sofia
city: Sofia
country: Bulgaria
facility: City Clin.Univ.MPHAT EOOD,Clin.of Cardiology, Sofia
city: Sofia
country: Bulgaria
facility: University Multiprofile Hospital for Active Treatement "Alexandrovska" EAD
city: Sofia
country: Bulgaria
facility: UMHAT "Tsaritsa Yoannalsul"
city: Sofia
country: Bulgaria
facility: Medical Military Academy MHAT Sofia
city: Sofia
country: Bulgaria
facility: Multiprofile Hospital MHATEM 'Pirogov', Sofia
city: Sofia
country: Bulgaria
facility: MHAT Sv.Anna, Clinic of Internal Diseases, Sofia
city: Stara Zagora
country: Bulgaria
facility: Hospital Trakia Park
city: Calgary
country: Canada
facility: Heritage Medical Research Clinic
state: Alberta
city: Edmonton
country: Canada
facility: Royal Alexandra Hospital
state: Alberta
city: Edmonton
country: Canada
facility: University of Alberta Hospital (University of Alberta)
state: Alberta
city: Kamloops
country: Canada
facility: Royal Inland Hospital
state: British Columbia
city: Surrey
country: Canada
facility: Surrey Memorial Hospital
state: British Columbia
city: Vancouver
country: Canada
facility: Vancouver General Hospital
state: British Columbia
city: Victoria
country: Canada
facility: Victoria Heart Institute Foundation
state: British Columbia
city: Winnipeg
country: Canada
facility: St. Boniface Hospital
state: Manitoba
city: Moncton
country: Canada
facility: GA Research Associates Ltd.
state: New Brunswick
city: Halifax
country: Canada
facility: QEII Health Sciences Centre
state: Nova Scotia
city: Brampton
country: Canada
facility: William Osler Health Centre
state: Ontario
city: Kingston
country: Canada
facility: Queen's University
state: Ontario
city: Mississauga
country: Canada
facility: One Heart Care Ventures
state: Ontario
city: Newmarket
country: Canada
facility: Southlake Regional Health Centre
state: Ontario
city: Peterborough
country: Canada
facility: Peterborough Regional Health Centre
state: Ontario
city: Scarborough
country: Canada
facility: Heart Health Institute
state: Ontario
city: Toronto
country: Canada
facility: Women's College Hospital
state: Ontario
city: Montreal
country: Canada
facility: Montreal Heart Institute
state: Quebec
city: Montreal
country: Canada
facility: Centre Hospitalier de l'Universite de Montreal (CHUM)
state: Quebec
city: Montreal
country: Canada
facility: Montreal General Hospital - McGill University Health Centre
state: Quebec
city: Montreal
country: Canada
facility: McGill University Health Centre (MUHC)
state: Quebec
city: Sainte-Foy
country: Canada
facility: IUCPQ (Laval University)
state: Quebec
city: Sherbrooke
country: Canada
facility: CIUSSS de l Estrie-CHUS
state: Quebec
city: Terrebonne (Lachenaie)
country: Canada
facility: CSSS du Sud de Lanaudiere - Hopital Pierre-Le Gardeur
state: Quebec
city: Trois-Rivieres
country: Canada
facility: CIUSSS de la Mauricie-et-du-Centre-du-Quebec
state: Quebec
city: Regina
country: Canada
facility: Prairie Vascular Research Inc.
state: Saskatchewan
city: Oakville
country: Canada
facility: Oakville Trafalgar Memorial Hospital
city: Beijing
country: China
facility: Beijing Chao-Yang Hospital
city: Beijing
country: China
facility: Chinese PLA General Hospital
city: Beijing
country: China
facility: China-Japan Friendship Hospital
city: Beijing
country: China
facility: Peking University First Hospital
city: Beijing
country: China
facility: Beijing Luhe Hospital Capital Medical University
city: Changsha
country: China
facility: Changsha Central Hospital
city: Changsha
country: China
facility: Xiangya Hospital, Central South University
city: Guangzhou
country: China
facility: Guangdong Provincial People's Hospital
city: Haerbin
country: China
facility: The First Affiliated Hospital of Harbin Medical University
city: Haikou
country: China
facility: Hainan General Hospital
city: Hangzhou
country: China
facility: Shulan(Hanghzhou) Hospital
city: Hangzhou
country: China
facility: Zhejiang Hospital
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine
city: Lanzhou
country: China
facility: The Second Affiliated Hospital of Lanzhou Medical University
city: Nanjing
country: China
facility: Nanjing Drum Tower Hospital
city: Shanghai
country: China
facility: Zhongshan Hospital Affiliated to Fudan University
city: Shenyang
country: China
facility: People's Hospital of Liaoning Province
city: Shenzhen
country: China
facility: Peking University Shenzhen Hospital
city: Wuhan
country: China
facility: Renmin Hospital of Wuhan University
city: Aalborg
country: Denmark
facility: Aalborg Universitetsshospital
city: Aarhus N
country: Denmark
facility: Aarhus University Hospital
city: Copenhagen
country: Denmark
facility: Rigshospitalet
city: Frederiksberg
country: Denmark
facility: Frederiksberg Hospital
city: Herlev
country: Denmark
facility: Herlev and Gentofte Hospital
city: Slagelse
country: Denmark
facility: Slagelse Sygehus
city: Corbeil Essonnes
country: France
facility: HOP Sud Francilien
city: Grenoble Cedex 9
country: France
facility: HOP CHU de Grenoble
city: Lille
country: France
facility: CHRU Lille
city: Lyon
country: France
facility: Hospital de Saint Joseph et Saint Luc
city: Paris
country: France
facility: HOP Bichat
city: Rouen Cedex
country: France
facility: CHU Rouen
city: Tours
country: France
facility: HOP Trousseau
city: Vandoeuvre-lès-Nancy
country: France
facility: HOP Brabois
city: Bad Friedrichshall
country: Germany
facility: SLK-Kliniken Heilbronn GmbH
city: Bad Nauheim
country: Germany
facility: Kerckhoff-Klinik, Bad Nauheim
city: Berlin
country: Germany
facility: Charité - Universitätsmedizin Berlin
city: Bonn
country: Germany
facility: Universitätsklinikum Bonn AöR
city: Bremen
country: Germany
facility: Bremer Institut für Herz- und Kreislaufforschung (BIHKF) am Klinikum Links der Weser
city: Coburg
country: Germany
facility: Klinikum Coburg gGmbH
city: Dortmund
country: Germany
facility: St. Johannes Hospital Dortmund
city: Dresden
country: Germany
facility: Städtisches Klinikum Dresden
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Frankfurt/Main
country: Germany
facility: Klinikum Frankfurt Höchst GmbH
city: Freiburg I. Breisgau
country: Germany
facility: Universitäts-Herzzentrum Freiburg, Bad Krozingen GmbH
city: Hamburg
country: Germany
facility: Asklepios Kliniken GmbH & Co. KGaA
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Kassel
country: Germany
facility: Ambulantes Herzzentrum Kassel
city: Leipzig
country: Germany
facility: Universitätsklinikum Leipzig
city: Mainz
country: Germany
facility: Katholisches Klinikum Mainz
city: Münster
country: Germany
facility: Clemenshospital
city: Papenburg
country: Germany
facility: Kardiologische Praxis Papenburg
city: Regensburg
country: Germany
facility: Universitätsklinikum Regensburg
city: Baja
country: Hungary
facility: Lausmed Kft. Outpatient Unit of Internal Medicine
city: Budapest
country: Hungary
facility: Buda Hospital of the Hospitaller Order of Saint John of God
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: St. Imre Hospital, Budapest
city: Budapest
country: Hungary
facility: Semmelweis University
city: Budapest
country: Hungary
facility: Magyar Honvedseg Egeszsegugyi Kozpont
city: Budapest
country: Hungary
facility: Jahn Ferenc Del-Pest Hospital
city: Debrecen
country: Hungary
facility: University Debrecen Hospital
city: Hodmezovasarhely
country: Hungary
facility: Csongrad Megyei Eu. Ellato Kozp. Hodmezovasarhely-Mako
city: Kaposvar
country: Hungary
facility: Somogy County Kaposi Mor Teaching Hospital
city: Kecskemet
country: Hungary
facility: Bacs-Kiskun Megyei Onkormanyzat Hospital
city: Kistarcsa
country: Hungary
facility: Pest Megyei Flor Ferenc Hospital
city: Szeged
country: Hungary
facility: University of Szeged
city: Szekesfehervar
country: Hungary
facility: Fejer County Saint George University Teaching Hospital
city: Szolnok
country: Hungary
facility: Jasz-Nagykun-Szolnok Megyei Hetenyi G. Korhaz-Rendelointezet
city: Zalaegerszeg
country: Hungary
facility: Zala County Hospital, Zalaegerszeg
city: Aurangabad
country: India
facility: Kamalnayan Bajaj Hospital
city: Bangalore
country: India
facility: Sri Jayadeva Institute of Cardiovascular Sciences & Research
city: Bangalore
country: India
facility: Narayana Institute of Cardiac Sciences
city: Belagavi
country: India
facility: KLES Dr.Prabhakar Kore Hospital and Medical Research Centre
city: Chennai
country: India
facility: Madras Medical Mission,
city: Jaipur
country: India
facility: Eternal Heart Care Centre & Research Institute Pvt. Ltd.
city: Mumbai
country: India
facility: KEM Hospital and Seth G S Medical College
city: Mumbai
country: India
facility: Sion Hospital (Lokmanya Tilak Municipal Hospital)
city: Nagpur
country: India
facility: Government Medical College & Hospital
city: New Delhi
country: India
facility: GB Pant Institute of Post Graduate Medical Education and Research
city: New Delhi
country: India
facility: Max Superspeciality Hospital
city: New Delhi
country: India
facility: Sir Gangaram Hospital
city: Pune
country: India
facility: Sahyadri Speciality Hospital
city: Afula
country: Israel
facility: Haemek Medical Center
city: Ashdod
country: Israel
facility: Assuta Medical Center
city: Ashkelon
country: Israel
facility: Barzilai Medical Center
city: Beer Sheba
country: Israel
facility: Soroka Univ. Medical Center
city: Beer Yaacov
country: Israel
facility: Assaf Harofe Medical Center
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center, Hadera
city: Haifa
country: Israel
facility: Rambam Medical Center
city: Haifa
country: Israel
facility: Bnei Zion Medical Center, Haifa
city: Haifa
country: Israel
facility: Lady Davis Carmel Medical Center
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Ein-Karem
city: Jerusalem
country: Israel
facility: Shaare Zedek Medical Center, Jerusalem 91031
city: Jerusalem
country: Israel
facility: Hadassah Medical Center, Ein-Karem
city: Kfar-Saba
country: Israel
facility: Meir Medical Center
city: Nahariya
country: Israel
facility: West.Galilee Med.Cent.Naharia
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson
city: Petah Tikva
country: Israel
facility: Rabin Medical Center Beilinson
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center Tel HaShomer
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Safed
country: Israel
facility: Ziv Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center
city: Tiberias
country: Israel
facility: Baruch Padeh Medical Center
city: Aichi, Kasugai
country: Japan
facility: Kasugai Municipal Hospital
city: Aichi, Toyota
country: Japan
facility: Toyota Memorial Hospital
city: Chiba, Matsudo
country: Japan
facility: Chibanishi General Hospital
city: Chiba, Matsudo
country: Japan
facility: Seikeikai New Tokyo Heart Clinic
city: Fukuoka, Fukuoka
country: Japan
facility: Saiseikai Fukuoka General Hospital
city: Gifu, Gifu
country: Japan
facility: Gifu Prefectural General Medical Center
city: Gifu, Ogaki
country: Japan
facility: Ogaki Municipal Hospital
city: Hatsukaichi
country: Japan
facility: Hiroshima General Hospital
city: Hiroshima, Hiroshima
country: Japan
facility: Hiroshima Prefectural Hospital
city: Hyogo, Himeji
country: Japan
facility: Hyogo Brain and Heart Center
city: Ibaraki, Kasama
country: Japan
facility: Ibaraki Prefectural Central Hospital
city: Ibaraki, Tsuchiura
country: Japan
facility: Tsuchiura Kyodo General Hospital
city: Ishikawa, Kanazawa
country: Japan
facility: Ishikawa Prefectural Central Hospital
city: Izunokuni
country: Japan
facility: Juntendo University Shizuoka Hospital
city: Kanagawa, Isehara
country: Japan
facility: Tokai University Hospital
city: Kanagawa, Sagamihara
country: Japan
facility: Sagamihara Kyodo Hospital
city: Kanagawa, Yokohama
country: Japan
facility: Yokohama City University Medical Center
city: Kasuga
country: Japan
facility: Fukuoka Tokushukai Hospital
city: Kumamoto, Kumamoto
country: Japan
facility: Saiseikai Kumamoto Hospital
city: Kumamoto, Kumamoto
country: Japan
facility: Japanese Red Cross Kumamoto Hospital
city: Kusatsu
country: Japan
facility: Kusatsu General Hospital
city: Miyazaki
country: Japan
facility: Miyazaki Medical Association Hospital
city: Nagano, Nagano
country: Japan
facility: Nagano Chuo Hospital
city: Osaka, Osaka
country: Japan
facility: Osaka Police Hospital
city: Takamatsu
country: Japan
facility: Kagawa Prefectural Central Hospital
city: Tokushima
country: Japan
facility: Tokushima Prefectural Central Hospital
city: Tokyo, Chuo-ku
country: Japan
facility: St. Luke's International Hospital
city: Urayasu
country: Japan
facility: Tokyo Bay Urayasu Ichikawa Medical Center
city: Yokohama
country: Japan
facility: Showa University Fujigaoka Hospital
city: Bucheon
country: Korea, Republic of
facility: Bucheon Sejong Hospital
city: Busan
country: Korea, Republic of
facility: Pusan National Univ. Hosp
city: Cheongiu
country: Korea, Republic of
facility: Chungbuk National University Hospital
city: Daejoen
country: Korea, Republic of
facility: Chungnam National University Hospital
city: Gwangju
country: Korea, Republic of
facility: Chonnam National University Hospital
city: Seongnam
country: Korea, Republic of
facility: Seoul National University Bundang Hospital
city: Wonju-si, Gangwon State
country: Korea, Republic of
facility: Yonsei University Wonju Severance Christian Hospital
city: Alkmaar
country: Netherlands
facility: Noordwest Ziekenhuisgroep
city: Amersfoort
country: Netherlands
facility: Meander Medisch Centrum
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Locatie VUMC
city: Amsterdam
country: Netherlands
facility: Onze Lieve Vrouwe Gasthuis
city: Arnhem
country: Netherlands
facility: Rijnstate Hospital
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Capelle Aan Den Ijssel
country: Netherlands
facility: IJsselland Ziekenhuis
city: Eindhoven
country: Netherlands
facility: Catharina Ziekenhuis
city: Enschede
country: Netherlands
facility: Medisch Spectrum Twente
city: Goes
country: Netherlands
facility: Admiraal de Ruyter Ziekenhuis
city: Groningen
country: Netherlands
facility: Universitair Medisch Centrum Groningen
city: Haarlem
country: Netherlands
facility: Spaarne Ziekenhuis
city: Heerlen
country: Netherlands
facility: Zuyderland Medisch Centrum
city: Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis-Hertogenbosch
city: Hilversum
country: Netherlands
facility: Tergooi Ziekenhuis
city: Hoorn
country: Netherlands
facility: Vasculair Onderzoek Centrum
city: Leeuwarden
country: Netherlands
facility: Medisch Centrum Leeuwarden
city: Leiden
country: Netherlands
facility: Leids Universitair Medisch Centrum (LUMC)
city: Leiden
country: Netherlands
facility: Alrijne Ziekenhuis
city: Tiel
country: Netherlands
facility: Ziekenhuis Rivierenland
city: Tilburg
country: Netherlands
facility: Tweesteden Ziekenhuis, locatie Tilburg
city: Zwolle
country: Netherlands
facility: Isala Zwolle
city: Belchatow
country: Poland
facility: American Heart of Poland
city: Bialystok
country: Poland
facility: Univ. Clinic Hosp, Bialystok
city: Bielsko-Biala
country: Poland
facility: American Heart of Poland Sp. z o.o.
city: Chorzow
country: Poland
facility: American-Polish Heart Clinic, Lesser Poland Cardiovascular Centre
city: Dabrowa Gornicza
country: Poland
facility: American Heart of Poland Sp. z o.o.
city: Gdynia
country: Poland
facility: NZOZ Pro-Cordis Sopockie Centrum Bad. Kardiolog.
city: Katowice
country: Poland
facility: Silesian Medical University in Katowice
city: Kedzierzyn-Kozle
country: Poland
facility: American Heart of Poland Sp. z o.o.
city: Krakow
country: Poland
facility: University Hospital in Krakow
city: Krakow
country: Poland
facility: The John Paul II Hosp.,Dept.of Coronary Heart Disease,Krakow
city: Nowy Targ
country: Poland
facility: Podhalanski Special.Hosp,Intern.Med&Cardiology Dept,Nowy Tag
city: Ostroleka
country: Poland
facility: Mazowiecki Szpital Specjalistyczny im. dr Jozefa Psarskiego
city: Oswiecim
country: Poland
facility: Medicome Limited Liability Company
city: Pulawy
country: Poland
facility: Independent Public Healthcare, Dept. of Cardiology, Pulawy
city: Sztum
country: Poland
facility: American Heart of Poland Sp. z o.o.
city: Tychy
country: Poland
facility: American Heart of Poland Sp. z o.o.
city: Walbrzych
country: Poland
facility: Dr Alfred Sokołowski Specialist Hospital
city: Warsaw
country: Poland
facility: Central Hospital of Medical Academy, Warsaw
city: Warsaw
country: Poland
facility: Instytut Kardiologii, Warszawa
city: Wroclaw
country: Poland
facility: Jan Mikulicz-Radecki UnivClinic Hosp,Cardiology Dept,Wroclaw
city: Wroclaw
country: Poland
facility: 4. Military Clinical Hospital with Polyclinic SP ZOZ
city: Baia Mare
country: Romania
facility: Emergency Clinical County Hospital, Baia Mare
city: Balotesti
country: Romania
facility: Spitalul Clinic De Urgenta "Prof. Dr. Agrippa Ionescu"
city: Braila
country: Romania
facility: Spitalul Judetean de Urgenta Braila
city: Brasov
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Brasov
city: Bucharest
country: Romania
facility: Military Central Clinical Emergency Hospital
city: Bucharest
country: Romania
facility: Elias Emergency Hospital, Bucharest
city: Bucharest
country: Romania
facility: Prof.C.C.Iliescu Hospital, National Institute of Cardiology
city: Bucharest
country: Romania
facility: Emergency Clinical Hospital "Bagdasar-Arseni"
city: Bucharest
country: Romania
facility: Emergency University Hospital, Bucharest
city: Cluj Napoca
country: Romania
facility: Heart Institute "Niculae Stancioiu", Cluj Napoca
city: Cluj Napoca
country: Romania
facility: Clincal Reabilitation Hospital, Cluj Napoca
city: Craiova
country: Romania
facility: Spitalul Clinic Judetean, Craiova
city: Iasi
country: Romania
facility: Cardiovascular Diseases Institute "Prof. Georgescu", Iasi
city: Iasi
country: Romania
facility: SC Cardiomed SRL, Iasi
city: Oradea
country: Romania
facility: SC Endodigest SRL
city: Pitesti
country: Romania
facility: Sal Med Srl
city: Sibiu
country: Romania
facility: Emergency County Clinical Hospital, Sibiu
city: Targu-Mures
country: Romania
facility: Centrul Medical Cardiomed
city: Targu-Mures
country: Romania
facility: Country Clinical Emergency Hospital, Targu-Mures
city: Timisoara
country: Romania
facility: Cardiology and Cardiovascular Rehabilitation Clinic
city: Arkhangelsk
country: Russian Federation
facility: First City Clinical Hospital named after E. E. Volosevich
city: Kirov
country: Russian Federation
facility: Regional Clinical Hospital, Kirov
city: Krasnodar
country: Russian Federation
facility: Regional Clinical Hospital No.1 named after Professor. S.V. Ochapovskiy
city: Moscow
country: Russian Federation
facility: State Healthcare Institution Clinical Hosp. No. 51, Moscow
city: Nizhniy Novgorod
country: Russian Federation
facility: Reg.Clin.Hosp.n.a.Semashko
city: Penza
country: Russian Federation
facility: Penza Regional Clinical Hospital named after N.N.Burdenko
city: Petrozavodsk
country: Russian Federation
facility: Republic Kareliya Republican Hosp. named after V.A. Baranov
city: Ryazan
country: Russian Federation
facility: GUZ Ryazanskiy Regional Clin. Cardiology Dispensary, Ryazan
city: Samara
country: Russian Federation
facility: Samara Regional Clinical Cardiology Clinic, Day Hosp. Dept.
city: Saratov
country: Russian Federation
facility: Saratov State Med.Univ.n.a.Razumovskogo
city: Saratov
country: Russian Federation
facility: Saratov Regional Cardiac Center
city: St. Petersburg
country: Russian Federation
facility: Saint-Petersburg I.I. Dzhanelidze Research Institute of Emergency Medicine
city: St. Petersburg
country: Russian Federation
facility: Medical Academy named after I. Mechnikov, St. Petersburg
city: Syktyvkar
country: Russian Federation
facility: Komi Republican Cardiological Dispensary
city: Tver
country: Russian Federation
facility: Regional clinical hospital, Tver
city: Tyumen
country: Russian Federation
facility: Tyumen Cardiology Center, Dept.of Cardiac Arrhythmia
city: Volgograd
country: Russian Federation
facility: State Budg.Healthc.Instit Volgograd RegClin.Cardiology Centr
city: Belgrade
country: Serbia
facility: Institute for Cardiovascular diseases Dedinje
city: Belgrade
country: Serbia
facility: University Clinical Center of Serbia
city: Belgrade
country: Serbia
facility: Clinical Hospital Center Dr. Dragisa Misovic
city: Belgrade
country: Serbia
facility: Clinical Medical Center Zvezdara, Belgrade
city: Kragujevac
country: Serbia
facility: University Clinical Center of Kragujevac
city: Leskovac
country: Serbia
facility: General Hospital Leskovac
city: Niska Banja
country: Serbia
facility: Institute for Treatment and Rehabilitation, Niska Banja
city: Nis
country: Serbia
facility: University Clinical Center Nis
city: Pancevo
country: Serbia
facility: General Hospital Pancevo
city: Sremska Kamenica
country: Serbia
facility: Institute of Cardiovascular Diseases
city: Sremska Mitrovica
country: Serbia
facility: General Hospital Sremska Mitrovica
city: Subotica
country: Serbia
facility: General Hospital Subotica, Internal Medicine
city: Uzice
country: Serbia
facility: Health Center Uzice
city: Zajecar
country: Serbia
facility: Health Centre Zajecar
city: Zrenjanin
country: Serbia
facility: General Hospital - Djordje Joanovic
city: Badalona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Barcelona
country: Spain
facility: University Hospital of Bellvitge
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Tarragona
country: Spain
facility: Hospital Universitari Joan XXIII
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo
city: Cherkasy
country: Ukraine
facility: Cherkasy Regional Cardiological Center
city: Dnepropetrovsk
country: Ukraine
facility: City Joint Emergency Hospital, Dnepropetrovsk
city: Ivano-Frankivsk
country: Ukraine
facility: Ivano-Frankivsk City Central Clinical Hospital
city: Ivano-Frankivsk
country: Ukraine
facility: Clinical Treatment and Diagnostic Center of the Limited Liability Company "SIMEDGROUP"
city: Kharkiv
country: Ukraine
facility: L.T. Malaya Institute of Therapy AMS of Ukraine
city: Kharkiv
country: Ukraine
facility: Reg.Clin.Hosp.Non-Commercial Enterprise
city: Kharkiv
country: Ukraine
facility: CI of Healthcare Kharkiv CCH #8, Kharkiv
city: Khmelnytskyi
country: Ukraine
facility: Khmelnytskyi Regional Hospital
city: Kiev
country: Ukraine
facility: Kiev City Clinical Hospital No. 5
city: Kiev
country: Ukraine
facility: SI NSC M.D. Strazhesko Institute Cardiology of NAMSU, Kyiv
city: Kiev
country: Ukraine
facility: City Clinical Hospital No. 1, Kiev
city: Kiev
country: Ukraine
facility: Kiev Emergency Care Hospital
city: Lutsk
country: Ukraine
facility: Lutsk City Clinical Hospital
city: Lviv
country: Ukraine
facility: Communal Noncommercial Enterprise of Lviv Regional Council "Lviv Regional Clinical Psychiatric Hospital"
city: Odesa
country: Ukraine
facility: Odesa Regional Clinical Hospital
city: Ternopil
country: Ukraine
facility: Regional Clinical Hospital, Ternopil
city: Uzhgorod
country: Ukraine
facility: Municipal Non-Profit Enterprise "Zakarpattia Regional Clinical Center of Cardiology and Cardiac Surgery" of Zakarpattia Regional Council
city: Zhytomyr
country: Ukraine
facility: Zhytomyr Regional Clinical Hospital, Dept. Endocrinology
Study officials:
References: