Evidence map›Paper›PMID 40728943›Full record

ArticleBrazilian journal of cardiovascular surgery2025

Study Design Update of the Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients: FRAGILE Trial.

Omar Asdrubal Vilca Mejia, Fabiane Letícia de Freitas, Bianca Meneghini, Maurilio Onofre Deininger, Rodrigo Segalote, Felipe Consentino, Mauricio Guerrieri, Alexandre Ciappina Hueb, Fernando Ribas, Rodrigo Moreira Castro and 6 more

Abstract readClinical Trial Protocol
PubMed Full text at PMC Publisher
In one paragraph

Article in Brazilian journal of cardiovascular surgery, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.

0numbers the graph read from it
0cells of the map it votes in
1citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

1 citing paper in PubMed.

  1. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

16 authors.

Omar Asdrubal Vilca MejiaInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, São Paulo, Brazil.ORCID 0000-0002-1635-4984
Fabiane Letícia de FreitasInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, São Paulo, Brazil.
Bianca MeneghiniDepartment of Internal Medicine and Endocrinology, Government Medical College, Srinagar, India.
Maurilio Onofre DeiningerHospital Alberto Urquiza Wanderley, Unimed, João Pessoa, Paraíba, Brazil.
Rodrigo SegaloteInstituto Nacional de Cardiologia (INC), Rio de Janeiro, Rio de Janeiro, Brazil.
Felipe ConsentinoInstituto Nacional de Cardiologia (INC), Rio de Janeiro, Rio de Janeiro, Brazil.
Mauricio GuerrieriHospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, Brazil.
Alexandre Ciappina HuebHospital das Clínicas Samuel Libânio, Pouso Alegre, Minas Gerais, Brazil.
Fernando RibasHospital Beneficência Portuguesa de São Paulo, São Paulo, São Paulo, Brazil.
Rodrigo Moreira CastroHospital Beneficência Portuguesa de São Paulo, São Paulo, São Paulo, Brazil.
Luís Roberto Palma DallanInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, São Paulo, Brazil.
Pedro Gm de Barros E SilvaBrazilian Clinical Research Institute, São Paulo, São Paulo, Brazil.
Renato D LopesBrazilian Clinical Research Institute, São Paulo, São Paulo, Brazil.
Luiz Augusto Ferreira LisboaInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, São Paulo, Brazil.
John PuskasEmory University Hospital Midtown, Atlanta, Georgia, United States of America.
Fabio B JateneInstituto do Coração do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo (InCor-HCFMUSP), São Paulo, São Paulo, Brazil.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

The Off-pump versus On-pump Coronary Artery Bypass Grafting in Frail Patients (FRAGILE Trial) is a multicenter, randomized controlled trial comparing off-pump and on-pump coronary artery bypass grafting in frail or pre-frail patients undergoing coronary artery bypass grafting. This manuscript presents an update to the FRAGILE Trial study design, detailing protocol modifications made in response to the time gap between the study's conception and its actual implementation. These changes were implemented early in the trial and were formally approved by the Ethics Committee, ensuring the scientific and ethical integrity of the study and reinforcing its relevance to address a gap in a vulnerable patient population.

Indexed as

Coronary Artery BypassCoronary Artery Bypass, Off-PumpFrailtyAgedFemaleFrail ElderlyHumansMulticenter Studies as TopicRandomized Controlled Trials as TopicResearch DesignTreatment OutcomeCABGCoronary Artery Bypass GraftsFrailty SyndromeOutcomes.Coronary Artery Disease

Identifiers

PMID40728943
PMCPMC12306569

What OpenQuestion holds

Textmetadata
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Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.