Fondazione Policlinico Universitario A Gemelli IRCCS
Roma, 00168, Italy
NCT Number: NCT07817524
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.
This study is active but is not currently recruiting participants.
Notify Me18 year and older
All sexes
Observational
Roma, 00168, Italy
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: through study completion, an average of 1 year
Number of patients who died for any cause after CABG or PCI
Time frame: through study completion, an average of 1 year
Number of patients who died for cardiovascolar causes after CABG or PCI
Time frame: through study completion, an average of 1 year
Number of patients who experienced myocardial infarction after CABG or PCI
Time frame: through study completion, an average of 1 year
Number of patients who needed rehospitalization after being discharged
Time frame: through study completion, an average of 1 year
Number of patients who needed repeated revascularization after CABG or PCI
Time frame: through study completion, an average of 1 year
Number of patients who had stroke after CABG or PCI
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Other
Clinical Outcome of Coronary Artery Bypass Graft Surgery Versus Percutaneous Coronary Intervention in Patients With Severe Left Ventricular Disfunction: the CROWN Study.
Acronym: CROWN
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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