TREatment With Beta-blockers After myOcardial Infarction withOut Reduced Ejection fracTion"

NCT ID: NCT03596385

Last Updated: 2025-06-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

8505 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-31

Study Completion Date

2025-01-31

Brief Summary

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REBOOT clinical trial will study whether long-term maintenance beta-blockers therapy results in a clinical benefit after heart attack without reduced left ventricular function. Half of the participants will be randomized to receive long-term beta-blocker therapy and the other half to no beta-blocker therapy after hospital discharge. All patients will be followed up for up to 5 years to determine the occurrence of adverse events (all cause mortality, re-infarction, and heart failure admission).

Detailed Description

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Pragmatic, controlled, prospective, randomized, open-label, blinded endpoint clinical trial testing the benefits of beta-blocker maintenance therapy in patients discharged after an acute myocardial infarction (MI). Patients being discharged after an acute MI, with or without ST-segment elevation, and with a left ventricular ejection fraction \>40%, and without history of heart failure (HF) prior to study inclusion, will be recruited. At discharge, patients will be randomized (1:1) to receive beta-blocker therapy (agent and dose according to treating physician) or no beta-blocker therapy. Primary outcome is the 5 years incidence of MACE (all cause mortality, reinfarction, heart failure admission).

Conditions

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Myocardial Infarction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Beta-blocker therapy

This is a strategy (pragmatic) trial. In patients allocated to "Beta-blocker therapy", beta blocker agent and dose are decided by treating physician.

betablocker therapy chosen might be any of the following: atenolol bisoprolol carvedilol metoprolol nebivolol

Group Type EXPERIMENTAL

Beta blocker

Intervention Type DRUG

long-term maintenance beta-blocker therapy

Control (no beta-blocker therapy).

Do not receive beta -blocker therapy

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Beta blocker

long-term maintenance beta-blocker therapy

Intervention Type DRUG

Other Intervention Names

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atenolol, bisoprolol, carvedilol, metoprolol, nevibolol.

Eligibility Criteria

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Inclusion Criteria

* ≥18 years old
* Admitted for STEMI or NSTEMI and invasive management (i.e. coronary angiography during index hospitalization).
* LVEF\>40% as evaluated by any imaging technique anytime during hospitalization.
* Signed informed consent

Exclusion Criteria

* Known allergy or intolerance to beta-blockers
* Absolute contraindication to beta-blocker therapy according to treating physician judge
* Prior history of HF, Killip class on admission or during hospitalization ≥ II
* Severe valvular heart disease (\> 3+ for aortic or mitral insufficiency, aortic or mitral valve area ≤1.0 cm2).
* Any condition (appart from AMI) that requires beta-blocker prescription on discharge according to treating physician judge
* Any medical condition that, in the investigator´s judgment, would seriously limit life expectancy (less than one year),
* Patients participating in other clinical trials
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fundación Centro Nacional de Investigaciones Cardiovasculares Carlos III

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Borja Ibañez, MD PhD FESC

Role: PRINCIPAL_INVESTIGATOR

CNIC

Locations

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Teresa Masselli Mascia

San Severo, Foggia, Italy

Site Status

Ospedale Civile Santi Antonio e Biagio

Alessandria, , Italy

Site Status

Azienda Ospedaliero Universitaria Ospedali Riuniti

Ancona, , Italy

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Ospedale Civile

Baggiovara, , Italy

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Istituto Maugeri IRCCS

Bari, , Italy

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Ospedale San Paolo

Bari, , Italy

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Ospedale Maggiore

Bologna, , Italy

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A.O. Sant'Anna e San Sebastiano di Caserta

Caserta, , Italy

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Santa Margherita

Cortona, , Italy

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Ospedale di Cremona

Cremona, , Italy

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Ospedale di Desio

Desio, , Italy

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Ospedale San Giuseppe

Empoli, , Italy

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Ospedale di Vaio

Fidenza, , Italy

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Azienda Ospedaliera Universitaria - Ospedali Riuniti Foggia

Foggia, , Italy

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Ospedale C.G.Morgagni

Forlì, , Italy

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Ospedale Misericordia

Grosseto, , Italy

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Ospedale Gualdo Tadino

Gubbio, , Italy

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Ospedale Civile di Legnano

Legnano, , Italy

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Ospedale di Vizzolo Predabissi

Melegnano, , Italy

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Mario Negri

Milan, , Italy

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Ospedale San Paolo

Milan, , Italy

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Ospedale Sacro Cuore Don Calabria

Negrar, , Italy

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Ospedale San Luigi Gonzaga

Orbassano, , Italy

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Policlinico San Marco

Osio Sotto, , Italy

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Villa Sofía, Palermo

Palermo, , Italy

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P.O. di Passirana

Passirana, , Italy

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Ospedale G. da Saliceto ,Piacenza

Piacenza, , Italy

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Ospedalel Santa Maria delle Croci

Ravenna, , Italy

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Arcispedale S. Maria Nuova

Reggio Emilia, , Italy

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Ospedale Infermi di Rimini

Rimini, , Italy

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San Filippo Neri

Roma, , Italy

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Presidio Ospedaliero di Saronno

Saronno, , Italy

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Ospedale Veris Delli Ponti

Scorrano, , Italy

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Ospedale Bolognini

Seriate, , Italy

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Ospedale di Treviglio

Treviglio, , Italy

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Ospedale di Udine

Udine, , Italy

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Fundación Jiménez Díaz University Hospital

Madrid, Madrid, Spain

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Complejo hospitalario universitario a Coruña

A Coruña, , Spain

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Txagorritxu

Alava, , Spain

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Fundacion Alcorcon

Alcorcón, , Spain

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Virgen de los Lirios de Alcoy

Alcoy, , Spain

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H. San Juan

Alicante, , Spain

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Hospital Alto del Gualdalquivir

Andújar, , Spain

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San Agustin

Avilés, , Spain

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Centro Medico Teknon

Barcelona, , Spain

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Clinic

Barcelona, , Spain

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Consorci Sanitari Integral

Barcelona, , Spain

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Germans Trias i Pujol

Barcelona, , Spain

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H. Vall d´Hebron

Barcelona, , Spain

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Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

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Hospital Universitario de Bellvitge

Barcelona, , Spain

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Hospital de Basurto

Bilbao, , Spain

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Hospital Universitario de Burgos

Burgos, , Spain

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H. Santa Lucía

Cartagena, , Spain

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Hosptial Universitario Reina Sofia

Córdoba, , Spain

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Hospital de Denia

Denia, , Spain

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Hospital universitario de Elche

Elche, , Spain

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Hospital Universitario de Vinalopo

Elche, , Spain

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H.Universitario de Elda

Elda, , Spain

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Hospital Arquitecto Macide

Ferrol, , Spain

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Hospital Galdakao Usansolo

Galdakao, , Spain

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Cabueñes

Gijón, , Spain

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Hospital San Cecilio

Granada, , Spain

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Hospital Virgen de las Nieves

Granada, , Spain

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H.U Juan Ramón Jimenez

Huelva, , Spain

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Complejo Hospitalario Universitario de Jaen

Jaén, , Spain

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Complejo Hospitalario Universitario Insular Materno Infantil

Las Palmas de Gran Canaria, , Spain

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Hospital de Leon

León, , Spain

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Hospital Universitario de Arnau de Vilanova

Lleida, , Spain

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Lucus Augusti

Lugo, , Spain

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Clinica La Luz

Madrid, , Spain

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CNIC

Madrid, , Spain

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Hospital 12 de Octubre

Madrid, , Spain

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Hospital Clinico

Madrid, , Spain

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Hospital Gregorio Marañon

Madrid, , Spain

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Hospital Quirón Pozuelo

Madrid, , Spain

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Ruber Internacional

Madrid, , Spain

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Ruber Juan Bravo

Madrid, , Spain

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Hospital de Manresa

Manresa, , Spain

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Hospital regional Universitario de Malaga

Málaga, , Spain

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Hospital Alvarez Buylla

Mieres, , Spain

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Rey Juan Carlos

Móstoles, , Spain

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Hospital Clinico Universitario Virgen de la Arrixaca

Murcia, , Spain

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Hospital Universitario Central Asturias

Oviedo, , Spain

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Son Espases

Palma de Mallorca, , Spain

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Complejo Hospitalario de Navarra

Pamplona, , Spain

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Montecelo

Pontevedra, , Spain

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Clinico Universitario de Salamanca

Salamanca, , Spain

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Complejo hospitalario Universitario de Canarias

Santa Cruz de Tenerife, , Spain

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Hospital General de La Palma

Santa Cruz de Tenerife, , Spain

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Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, , Spain

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Marques de Valdecilla

Santander, , Spain

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Complejo hospitalario universitario de Santiago

Santiago de Compostela, , Spain

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H. Virgen del Rocio

Seville, , Spain

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Virgen de la Macarena

Seville, , Spain

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Hospital Universitari Joan XXIII

Tarragona, , Spain

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Hospital Universitario Sant Joan de Reus

Tarragona, , Spain

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Hospital Universitario de Torrejon

Torrejón de Ardoz, , Spain

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Hospital Universitario de Torrevieja

Torrevieja, , Spain

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H. Verge de la Cinta

Tortosa, , Spain

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San Juan de la Cruz

Úbeda, , Spain

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Hospital Infanta Elena

Valdemoro, , Spain

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Hospital Clinico

Valencia, , Spain

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Hospital La Fe

Valencia, , Spain

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Hospital universitario doctor Peset

Valencia, , Spain

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IMED Valencia

Valencia, , Spain

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Hospital Clinico universitario de Valladolid

Valladolid, , Spain

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Río Hortega

Valladolid, , Spain

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Alvaro Cunqueiro

Vigo, , Spain

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Hospital General de Villalba

Villalba, , Spain

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Miguel Servet

Zaragoza, , Spain

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Countries

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Italy Spain

References

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Rossello X, Raposeiras-Roubin S, Latini R, Dominguez-Rodriguez A, Barrabes JA, Sanchez PL, Anguita M, Fernandez-Vazquez F, Pascual-Figal D, De la Torre Hernandez JM, Ferraro S, Vetrano A, Perez-Rivera JA, Prada-Delgado O, Escalera N, Staszewsky L, Pizarro G, Aguero J, Pocock S, Ottani F, Fuster V, Ibanez B; REBOOT-CNIC investigators. Rationale and design of the pragmatic clinical trial tREatment with Beta-blockers after myOcardial infarction withOut reduced ejection fracTion (REBOOT). Eur Heart J Cardiovasc Pharmacother. 2022 May 5;8(3):291-301. doi: 10.1093/ehjcvp/pvab060.

Reference Type BACKGROUND
PMID: 34351426 (View on PubMed)

Ibanez B, Latini R, Rossello X, Dominguez-Rodriguez A, Fernandez-Vazquez F, Pelizzoni V, Sanchez PL, Anguita M, Barrabes JA, Raposeiras-Roubin S, Pocock S, Escalera N, Staszewsky L, Perez-Garcia CN, Diez-Villanueva P, Perez-Rivera JA, Prada-Delgado O, Owen R, Pizarro G, Caldes O, Gomez-Talavera S, Tunon J, Bianco M, Zarauza J, Vetrano A, Campos A, Martinez-Huertas S, Bueno H, Puentes M, Grigis G, Bonilla-Palomas JL, Marco E, Gonzalez-Juanatey JR, Bangueses R, Gonzalez-Juanatey C, Garcia-Alvarez A, Ruiz-Garcia J, Carrasquer A, Garcia-Rubira JC, Pascual-Figal D, Tomas-Querol C, San Roman JA, Baratta P, Aguero J, Martin-Reyes R, Colivicchi F, Ortas-Nadal R, Bazal P, Cordero A, Fernandez-Ortiz A, Basso P, Gonzalez E, Poletti F, Bugani G, Debiasio M, Cosmi D, Navazio A, Bermejo J, Tortorella G, Marini M, Botas J, de la Torre-Hernandez JM, Ottani F, Fuster V; REBOOT-CNIC Investigators. Beta-Blockers after Myocardial Infarction without Reduced Ejection Fraction. N Engl J Med. 2025 Aug 30. doi: 10.1056/NEJMoa2504735. Online ahead of print.

Reference Type DERIVED
PMID: 40888702 (View on PubMed)

Granger CB, Pocock SJ, Gersh BJ. The need for new clinical trials of old cardiovascular drugs. Nat Rev Cardiol. 2023 Feb;20(2):71-72. doi: 10.1038/s41569-022-00819-1. No abstract available.

Reference Type DERIVED
PMID: 36526898 (View on PubMed)

Other Identifiers

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REBOOT-CNIC

Identifier Type: -

Identifier Source: org_study_id

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