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NCT05701358Active, not recruiting

Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization for Acute MI & Multivessel Disease

A Randomized Trial of Physiology-guided vs Angiography-guided Non-culprit Lesion Complete Revascularization Strategies & an Observational Study of Optical Coherence Tomography in Patients With Acute MI & Multivessel Coronary Artery Disease

Source: ClinicalTrials.gov · Last updated 20 Oct 2026

Brief summary (registry, in English)

COMPLETE-2 is a prospective, multi-centre, randomized controlled trial comparing a strategy of physiology-guided complete revascularization to angiography-guided complete revascularization in patients with acute ST-segment elevation myocardial infarction (STEMI) or non-ST-segment elevation myocardial infarction (NSTEMI) and multivessel coronary artery disease (CAD) who have undergone successful culprit lesion Percutaneous Coronary Intervention (PCI). COMPLETE-2 OCT is a large scale, prospective, multi-centre, observational, imaging study of patients with STEMI or NSTEMI and multivessel CAD in a subset of eligible COMPLETE-2 patients.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
5100 (estimated)
First submitted
17 Jan 2023
Start date
22 Jun 2023
Primary completion date
Jun 2028
Lead sponsor
Population Health Research Institute
NCT number
NCT05701358

What you commit to

  • Study type: Interventional
  • Planned participants: 5100
  • From 22 Jun 2023 to the primary completion date, Jun 2028
  • 138 sites in 20 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Planned or prior coronary artery bypass graft (CABG) surgery
  • Prior PCI of a non-culprit lesion in a different vessel from the culprit lesion within 45 days of randomization

Age

  • Non-cardiovascular co-morbidity with expected life expectancy \<2 years

Other

  • Inability to clearly identify a culprit lesion for STEMI or NSTEMI based on angiographic appearance and/or ECG changes and/or regional wall motion abnormalities
  • Planned medical treatment of all qualifying non-culprit lesions (i.e., no PCI)
  • Presence of severe non-culprit-lesion stenosis with reduced epicardial flow (TIMI flow ≤ 2) or \>90% visual diameter stenosis
  • Presence of a chronic total occlusion (CTO) if it is the only qualifying non-culprit lesion (patients with a CTO plus additional qualifying non-culprit lesions are eligible)
  • The only qualifying non-culprit lesion is in the same vessel territory as the culprit lesion
  • Baseline STEMI or NSTEMI was due to a suspected non-atherothrombotic mechanism such as type 2 MI (supply-demand mismatch), including spontaneous coronary artery dissection or coronary artery embolism
  • Any other medical, geographic, or social factor making study participation impractical or precluding 5 year follow-up

Who the study is looking for

  • Patients presenting with STEMI or type 1 NSTEMI and within 72 hours of successful culprit-lesion PCI
  • Residual coronary artery disease defined as at least 1 additional non-infarct-related coronary artery stenosis that meets all of the following criteria:
    • Amenable to successful treatment with PCI
    • At least 50% diameter stenosis by visual estimation
    • At least 2.5 mm in diameter
  • Planned complete revascularization strategy for qualifying MI

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (138)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Klinik Floridsdorf
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ViennaAustriaUnknown status
Flinders Medical Centre
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Bedford ParkAustraliaUnknown status
Eastern Health
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Box HillAustraliaUnknown status
Campbelltown Hospital
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CampbelltownAustraliaUnknown status
The Prince Charles Hospital
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ChermsideAustraliaUnknown status
Gosford Hospital
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GosfordAustraliaUnknown status
Northern Health
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MelbourneAustraliaUnknown status
Royal Melbourne Hospital
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ParkvilleAustraliaUnknown status
Royal Perth Hospital
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PerthAustraliaUnknown status
Westmead Hospital
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WestmeadAustraliaUnknown status
William Osler Health System
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BramptonCanadaUnknown status
University of Alberta Hospital, Mazankowski Heart
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EdmontonCanadaUnknown status
Hamilton Health Sciences
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HamiltonCanadaUnknown status
Kingston Health Sciences Centre
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KingstonCanadaUnknown status
St. Mary's General Hospital
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KitchenerCanadaUnknown status
London Health Sciences Centre
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LondonCanadaUnknown status
Centre Hospitalier de l'Université de Montréal
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MontrealCanadaUnknown status
Hopital Du Sacre Coeur de Montreal
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MontrealCanadaUnknown status
McGill University Health Centre (MUHC)
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MontrealCanadaUnknown status
Southlake Regional Health Centre
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NewmarketCanadaUnknown status
Nova Scotia Health
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Nova ScotiaCanadaUnknown status
University of Ottawa Heart Institute
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OttawaCanadaUnknown status
Institut universitaire de cardiologie et de pneumologie de Québec
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QuébecCanadaUnknown status
Regina General Hospital
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ReginaCanadaUnknown status
Royal University Hospital
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SaskatoonCanadaUnknown status
Niagara Health
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St. CatharinesCanadaUnknown status
Newfoundland and Labrador Health Services
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St. John'sCanadaUnknown status
Thunder Bay Regional Health Sciences Centre
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Thunder BayCanadaUnknown status
St. Michael's Hospital, Unity Health Toronto
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TorontoCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
Ciusss McQ - Chaur
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Trois-RivièresCanadaUnknown status
St. Paul's Hospital
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VancouverCanadaUnknown status
Vancouver General Hospital
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VancouverCanadaUnknown status
St. Boniface Hospital
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WinnipegCanadaUnknown status
Kerckhoff Klinik, Bad Nauheim
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Bad NauheimGermanyUnknown status
Berufsgenossenschaftliches Universitatsklinikum
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BochumGermanyUnknown status
St. Vinzenz-Hospital
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CologneGermanyUnknown status
Helios Amper-Klinikum
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DachauGermanyUnknown status
Universitätsklinikum Frankfurt
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FrankfurtGermanyUnknown status
Schoen Klink Hamburg
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HamburgGermanyUnknown status
University Heart & Vascular Center Hamburg
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HamburgGermanyUnknown status
WKK Heide
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HeideGermanyUnknown status
Heart Center Leipzig
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LeipzigGermanyUnknown status
Aalborg University Hospital
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AalborgDenmarkUnknown status
Aarhus University Hospital
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AarhusDenmarkUnknown status
Rigshospitalet (Copenhagen University Hospital)
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CopenhagenDenmarkUnknown status
Hospital Ramón y Cajal
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MadridSpainUnknown status
Hospital Universitario de la Princesa
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Clínico San Carlos
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MadridSpainUnknown status
Hospital Virgen Del Rocio
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SevilleSpainUnknown status
Hospital Universitari i Politécnic La Fe
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ValenciaSpainUnknown status
Hospital Clínico Universitario de Valladolid
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ValladolidSpainUnknown status
Helsinki University Hospital
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HelsinkiFinlandUnknown status
TAYS Sydankeskus Oy
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TampereFinlandUnknown status
Turku University Hospital
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TurkuFinlandUnknown status
East Kent Hospitals University NHS Foundation Trust
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AshfordUnited KingdomUnknown status
Blackpool Teaching Hospitals
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BlackpoolUnited KingdomUnknown status
Ninewells Hospital
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DundeeUnited KingdomUnknown status
Harefield Hospital
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HarefieldUnited KingdomUnknown status
Kettering General Hospital
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KetteringUnited KingdomUnknown status
Leeds General Infirmary
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LeedsUnited KingdomUnknown status
University Hospitals of Leicester
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LeicesterUnited KingdomUnknown status
Liverpool Heart and Chest Hospital
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LiverpoolUnited KingdomUnknown status
Imperial College Healthcare NHS Trust
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LondonUnited KingdomUnknown status
Royal Free London NHS Foundation Trust
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LondonUnited KingdomUnknown status
Barts Health NHS Trust
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LondonUnited KingdomUnknown status
Western Health and Social Care Trust
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LondonderryUnited KingdomUnknown status
Manchester University NHS Foundation Trust
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ManchesterUnited KingdomUnknown status
The James Cook University Hospital
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MiddlesbroughUnited KingdomUnknown status
Freeman Hospital
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Newcastle upon TyneUnited KingdomUnknown status
Royal Berkshire Foundation NHS Trust
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ReadingUnited KingdomUnknown status
Sheffield Teaching Hospitals
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SheffieldUnited KingdomUnknown status
East and North Hertfordshire NHS Trust
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StevenageUnited KingdomUnknown status
Royal Cornwall Hospitals NHS Trust
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TruroUnited KingdomUnknown status
The Royal Wolverhampton NHS Trust
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WolverhamptonUnited KingdomUnknown status
Worcestershire Acute Hospitals NHS Trust
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WorcesterUnited KingdomUnknown status
General University Hospital of Patras
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RioGreeceUnknown status
Semmelweis University - Heart and Vascular Center
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BudapestHungaryUnknown status
Gottsegen National Cardiovascular Center
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BudapestHungaryUnknown status
Szabolcs-Szatmar-Bereg County Hospitals and University
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NyíregyházaHungaryUnknown status
University of Szeged
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SzegedHungaryUnknown status
University Hospital Galway
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GalwayIrelandUnknown status
The Madras Medical Mission
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ChennaiIndiaUnknown status
Apollo Hospital
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ChennaiIndiaUnknown status
Lisie Hospital
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ErnākulamIndiaUnknown status
Medanta The Medicity
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GurugramamIndiaUnknown status
Apollo Rajshree Hospitals
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IndoreIndiaUnknown status
Rukmani Birla Hospital
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JaipurIndiaUnknown status
Meditrina Hospital
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KollamIndiaUnknown status
Caritas Hospital Trust
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KottayamIndiaUnknown status
Meenakshi Mission Hospital and Research Center
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MaduraiIndiaUnknown status
Krishna Institute of Medical Sciences
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SecunderabadIndiaUnknown status
Azienda USL Toscana Sud Est
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ArezzoItalyUnknown status
UOC Cardiologia - Ospedale Maggiore
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BolognaItalyUnknown status
Azienda Ospedaliero Universitaria di Ferrara
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FerraraItalyUnknown status
Misericordia Hospital
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GrossetoItalyUnknown status
Fondazione IRCCS Policlinico San Matteo
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PaviaItalyUnknown status
Azienda USL-IRCCS di Reggio Emilia, Reggio
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Reggio EmiliaItalyUnknown status
Sant Andrea Hospital - Sapienza University
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RomeItalyUnknown status
AOU Città della Salute e della Scienza di Torino
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TorinoItalyUnknown status
OLVG
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AmsterdamNetherlandsUnknown status
Albert Schweitzer Ziekenhuis
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DordrechtNetherlandsUnknown status
Zuyderland Medisch Centrum
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HeerlenNetherlandsUnknown status
Radboud University Medical Cente
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NijmegenNetherlandsUnknown status
Sorlandet Hospital Arendal
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KristiansandNorwayUnknown status
Oslo University Hospital Ullevål
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OsloNorwayUnknown status
Stavanger University Hospital
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StavangerNorwayUnknown status
Provincial Specialized Hospital
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LegnicaPolandUnknown status
Miedziowym Centrum Zdrowia S.A. w Lubinie
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LubinPolandUnknown status
Medical University of Warsaw
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WarsawPolandUnknown status
Tadeusz Marciniak Lower Silesia Specialist Hospital
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WroclawPolandUnknown status
Provincial Specialist Hospital in Wroclaw
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WroclawPolandUnknown status
University Clinical Center of Serbia
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BelgradeSerbiaUnknown status
Institute for Cardiovascular Diseases Dedinje
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BelgradeSerbiaUnknown status
Sahlgrenska University Hospital
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GothenburgSwedenUnknown status
Karolinska University Hospital
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HuddingeSwedenUnknown status
Lanssjukhuset Ryhov
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JönköpingSwedenUnknown status
Karlstad Central Hospital
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KarlstadSwedenUnknown status
Skåne University Hospital
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LundSwedenUnknown status
Danderyd Hospital
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StockholmSwedenUnknown status
Umeå University Hospital
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UmeåSwedenUnknown status
Uppsala University Hospital
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UppsalaSwedenUnknown status
University of Michigan
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Ann ArborUnited StatesUnknown status
The Johns Hopkins University School of Medicine
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BaltimoreUnited StatesUnknown status
University of Virginia Medical Center
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CharlottesvilleUnited StatesUnknown status
Cleveland Clinic
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ClevelandUnited StatesUnknown status
Metropolitan Cardiology Consultants / Metropolitan Heart and Vascular Institute (MCC/MHVI)
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Coon RapidsUnited StatesUnknown status
Bassett Medical Center
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CooperstownUnited StatesUnknown status
RWJ Barnabas Health
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Jersey CityUnited StatesUnknown status
UCLA
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Los AngelesUnited StatesUnknown status
NYU Grossman School of Medicine
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New YorkUnited StatesUnknown status
VA New York Harbor Healthcare System
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New YorkUnited StatesUnknown status
The Heart Hospital Baylor Plano
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PlanoUnited StatesUnknown status
University of California San Francisco
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San FranciscoUnited StatesUnknown status
Montefiore Medical Center
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The BronxUnited StatesUnknown status
Cardiovascular Research Institute of Kansas
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WichitaUnited StatesUnknown status
Groote Schuur Hospital
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Cape TownSouth AfricaUnknown status

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