IncidenCe and predictOrs of heaRt fAiLure after acute coronarY Syndrome: The CORALYS registry.
Ovidio De Filippo, Fabrizio D'Ascenzo, Wojciech Wańha...
https://pubmed.ncbi.nlm.nih.gov/36306949/Actively Recruiting
Led by Federico II University · Updated on 2025-03-03
5000
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are conducting a prospective observational study to evaluate the current epidemiology, management, and clinical outcomes of patients with acute cardiovascular diseases admitted to the Intensive Cardiac Care Unit ICCU at the University Hospital Federico II. The focus is on conditions such as acute cardiovascular disease, acute coronary syndrome, acute heart failure, and cardiogenic shock. This study aims to collect comprehensive data to better understand patient care and outcomes without introducing new treatments. The study does not involve any experimental treatments or procedures but observes the usual guideline-directed care provided in the ICCU. Data collection includes demographic, clinical, procedural, therapeutic, and outcome information from patient admission onward. Follow-ups occur during the hospital stay, and at 30 days, 1 year, and the longest available period, through telephone or visits. An independent clinical events committee will review the main clinical outcomes. Participants will provide informed consent upon admission, after which all relevant data will be gathered and anonymized using a secure electronic system. Outcomes assessed include mortality, heart attacks, strokes, heart failure events, bleeding, kidney injury, length of hospital stay, use of mechanical support, neurological status, and quality of life at various time points. The study is overseen by the Clinical Trial Unit at the University of Naples Federico II, ensuring careful data management and patient follow-up until the studys end in 2033.
CONDITIONS
Naples Federico II Intensive Cardiac Care Unit Registry (Naples FED2-ICCU Registry)
G
Giuseppe Gargiulo, MD, PhD
G
Giovanni Esposito, MD, PhD
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Federico II University
Lead Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 1 year or longer depending on follow-up
Participants who undergo routine care in the Intensive Cardiac Care Unit are observed. Data including demographic, clinical, procedural, therapeutic, and outcome information is collected during the hospital stay and through follow-up assessments.
In-hospital assessments plus follow-up visits or telephone calls at 30 days, 1 year, and longest available follow-up
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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