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Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment (COMFORT)

17. juli 2026 opdateret af: Hamilton Health Sciences Corporation

COMFORT: Comparative Outcomes of Mammary Artery Harvesting: Infection, Occlusion Rates and Thoracic Pain Assessment

The COMFORT Trial is a randomized controlled superiority trial comparing skeletonized (SK) versus non-skeletonized (non-SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft in patients undergoing isolated coronary artery bypass grafting (CABG).

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

The COMFORT trial is an international, multicentre, blinded, expertise-based randomized controlled trial evaluating two commonly used techniques for harvesting the left internal mammary artery (LIMA) during coronary artery bypass grafting (CABG): skeletonized and non-skeletonized (pedicled) harvesting.

Although skeletonized harvesting has been associated with reduced sternal wound complications and postoperative pain, concerns have emerged regarding its potential impact on graft patency and long-term cardiovascular outcomes. Existing evidence is largely derived from observational studies and post hoc analyses, and no adequately powered randomized trial has prospectively compared these techniques using systematic imaging-based graft assessment.

The COMFORT trial will enroll approximately 1,116 patients undergoing isolated CABG with a planned LIMA-to-LAD graft. Participants will be randomly assigned to undergo either skeletonized or non-skeletonized LIMA harvesting performed by surgeons experienced in both techniques. Participants and outcome assessors will remain blinded to treatment allocation.

Participants will undergo protocol-mandated coronary computed tomography angiography (CTA) at 1.5 years after surgery, with follow-up extending to 2 years. Independent blinded committees and a central CTA core laboratory will adjudicate imaging and clinical outcomes. In addition to graft assessment, the study will evaluate the effects of harvesting technique on cardiovascular outcomes, sternal wound complications, chronic postoperative pain, quality of life, and healthcare resource utilization.

The findings of COMFORT are expected to provide definitive evidence to guide surgical practice and inform future guidelines regarding the optimal method of internal mammary artery harvesting during CABG surgery.

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

1116

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

Inclusion Criteria:

  1. Age 18 years or older
  2. Undergoing isolated CABG surgery with median sternotomy and a planned LIMA-LAD graft
  3. Provision of written informed consent

Exclusion Criteria:

  1. Non-sternotomy surgical approach (e.g., minimally invasive, thoracotomy)
  2. Emergency surgery (defined as surgery required within 24 hours of presentation)
  3. History of prior sternotomy
  4. Currently receiving systemic antibiotics or with an active bacterial infection at the time of surgery
  5. History of chronic sternal pain prior to the index surgery
  6. Known left subclavian artery stenosis (>50%)
  7. Previous radiation therapy to the chest
  8. Known allergy or contraindication to iodinated contrast media that cannot be managed with premedication
  9. Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73m² at baseline (relative contraindication to CTA contrast) as determined based on each centre's laboratory standard.
  10. Known pregnancy or plans for pregnancy during the study period
  11. Life expectancy less than 1.5 years due to non-cardiac conditions
  12. Inability or unwillingness to comply with follow-up procedures including CTA at 1.5 years

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Skeletonized LIMA Harvesting
Harvesting of the left internal mammary artery as a skeletonized conduit during CABG surgery, with removal of surrounding tissues while preserving the artery as an isolated graft conduit.
Procedure: Skeletonized LIMA Harvesting
Skeletonized (SK) harvesting of the left internal mammary artery (LIMA) to left anterior descending artery (LAD) graft: the LIMA is isolated without surrounding satellite veins, endothoracic fascia, and intercostal nerves
Aktiv komparator: Non-Skeletonized LIMA Harvesting
Conventional pedicled harvesting of the left internal mammary artery during CABG surgery, with preservation of the surrounding veins, fascia, and supporting tissues around the graft conduit.
Procedure: Non-Skeletonized LIMA Harvesting
Non-skeletonized (non-SK) harvesting of the LIMA-LAD graft: the LIMA is harvested with surrounding satellite veins, endothoracic fascia, and intercostal nerves (standard pedicled technique)

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Graft Patency
Tidsramme: 1.5 years after surgery
Binary assessment of LIMA-LAD graft patency versus graft failure
1.5 years after surgery

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
MACE
Tidsramme: 2 years after surgery
The composite of cardiovascular mortality, myocardial infarction, or repeat revascularization
2 years after surgery
Sternal Surgical Site Infection
Tidsramme: 90 days after surgery
The composite of sternal surgical site infection
90 days after surgery
Sternal Chronic Postsurgical Pain
Tidsramme: 90 days after surgery
The composite of non-infected sternal chronic postsurgical pain
90 days after surgery
LIMA-LAD Driven Repeat Revascularization or Occlusion
Tidsramme: 2 years after surgery
Any coronary revascularization procedure (PCI or CABG) targeting the LIMA-LAD graft territory, or occlusion of the LIMA-LAD graft revealed by clinically indicated coronary angiography or CTA
2 years after surgery

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Hamilton Health Sciences Corporation

Samarbejdspartnere

Population Health Research Institute

Efterforskere

  • Ledende efterforsker: Andre Lamy, MD, Population Health Research Institute

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. september 2026

Primær færdiggørelse (Anslået)

31. december 2028

Studieafslutning (Anslået)

30. april 2029

Datoer for studieregistrering

Først indsendt

17. juli 2026

Først indsendt, der opfyldte QC-kriterier

17. juli 2026

Først opslået (Faktiske)

22. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

22. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

17. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • COMFORT

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

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Kliniske forsøg med Koronararteriesygdom

Kliniske forsøg med Skeletonized LIMA Harvesting

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