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Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction (CROWN) (CROWN)

10. september 2026 oppdatert av: Chiariello Giovanni A, Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction: the CROWN Study.

The objective of this study is to evaluate the best treatment strategy in patients with critical coronary artery disease and severe left ventricular dysfunction.

In details, main goal of the study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention.

Studieoversikt

Status

Aktiv, ikke rekrutterende

Detaljert beskrivelse

Despite CABG being increasingly performed in patients with reduced EF, the literature lacks of data directly comparing the clinical outcomes of surgical versus percutaneous revascularization in patients with left ventricular dysfunction.

The goal of this study is to compare the clinical outcomes of patients with critical coronary artery disease and severe left ventricular dysfunction undergoing surgical coronary artery bypass grafting with those of patients treated by percutaneous coronary intervention (PCI).

All patients affected by coronary artery disease who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023, and who meet the inclusion and exclusion criteria, will be included in the study. Each patient will be enrolled following an interview and the subsequent signing of the informed consent form. Data will then be recorded in a dedicated database. In detail, the following information will be collected: anamnestic data, description of the performed procedure, preoperative and postoperative laboratory test results, preoperative, intraoperative, and postoperative echocardiographic parameters (including follow-up visits up to 2 years after the procedure), length of stay in the Intensive Care Unit and in the general ward, and data regarding any intraoperative and postoperative complications (death, shock, pericardial effusion, stroke, myocardial infarction, need for postoperative PCI, rehospitalization, heart failure). All data recorded in the database are routinely collected for all patients undergoing this type of intervention, and no additional examinations will be performed on patients included in the study.

Studietype

Observasjonsmessig

Registrering (Antatt)

300

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

      • Roma, Italia, 00168
        • Fondazione Policlinico Universitario A Gemelli IRCCS

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

  • Voksen
  • Eldre voksen

Tar imot friske frivillige

Nei

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

All patients affected by coronary artery disease and severe left ventricular disfunction who underwent surgical treatment (coronary artery bypass grafting, CABG) or percutaneous treatment (percutaneous coronary intervention, PCI) between January 2019 and December 2023.

Beskrivelse

Inclusion Criteria:

  • Age >= 18 years old;
  • Written informed consent;
  • Indication to CABG surgery (both "on-pump" and "off-pump") or to PCI;
  • Preoperative EF ≤35%.

Exclusion Criteria:

  • Inability to give written informed consent;
  • Emergency surgery;
  • Combined cardiac surgical procedures;
  • Previous cardiac surgery.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

Kohorter og intervensjoner

Gruppe / Kohort
CABG
Patients with critical coronary artery disease and severe left ventricular disfunction treated with coronary artery bypass graft surgery
PCI
Patients with critical coronary artery disease and severe left ventricular disfunction treated with percutaneous coronary intervention

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
All-cause mortality
Tidsramme: through study completion, an average of 1 year
Number of patients who died for any cause after CABG or PCI
through study completion, an average of 1 year

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Mortality from cardiovascular causes
Tidsramme: through study completion, an average of 1 year
Number of patients who died for cardiovascolar causes after CABG or PCI
through study completion, an average of 1 year
Acute myocardial infarction
Tidsramme: through study completion, an average of 1 year
Number of patients who experienced myocardial infarction after CABG or PCI
through study completion, an average of 1 year
Rehospitalization from cardiovascular reasons
Tidsramme: through study completion, an average of 1 year
Number of patients who needed rehospitalization after being discharged
through study completion, an average of 1 year
Repeated revascularization
Tidsramme: through study completion, an average of 1 year
Number of patients who needed repeated revascularization after CABG or PCI
through study completion, an average of 1 year
Stroke
Tidsramme: through study completion, an average of 1 year
Number of patients who had stroke after CABG or PCI
through study completion, an average of 1 year

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart (Faktiske)

1. august 2025

Primær fullføring (Antatt)

31. desember 2026

Studiet fullført (Antatt)

28. februar 2027

Datoer for studieregistrering

Først innsendt

5. september 2026

Først innsendt som oppfylte QC-kriteriene

10. september 2026

Først lagt ut (Faktiske)

14. september 2026

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

14. september 2026

Siste oppdatering sendt inn som oppfylte QC-kriteriene

10. september 2026

Sist bekreftet

1. september 2026

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

NEI

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

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