Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease

Recruiting

• Conditions: Acute Decompensated Heart Failure; Cardiogenic Shock; Acute Myocardial Infarction; Acute Pulmonary Embolism

• Registration Number: NCT06081205
• Lead Sponsor: University Hospital, Ioannina

Brief Summary

This is a registry of the patients that are admitted to CICU and treated by the Scientific Staff of the 2nd Department of Cardiology, due to an acute cardiovascular disease (acute coronary syndrome, acute heart failure, arrhythmia, pulmonary embolism, cardiac tamponade etc) in order to investigate the clinical characteristics of the patients, their outcome, identify the factors that could predict the in-hospital mortality and compare the results with the predicted by established risk scores. Furthermore, the study will investigate the one-year mortality and also the major adverse cardiac events (MACE - acute myocardial infarction, stroke, or cardiovascular death) will be measured.

Detailed Description

For every patient that will be enrolled to the study, information from the medical record will be collected, as long as he/she has provided a signed consent form after being fully informed of the study and its objectives. In case the patient cannot decide on his/her own, e.g. intubated patients, an informed consent form must be acquired by a relative or legal representative. Only the data that will be considered necessary for scientific reasons will be acquired: general and demographic information, medical information like the personal and family history, the diagnostic tests performed and the treatments or interventions that took place. The patients will not have to do anything further or undergo any additional visits or medical exams apart from those indicated; they will not receive any extra treatment (because of their participation to the study) beyond what they would receive for their condition according to the established practice so far. Furthermore, the doctor will not change or withdraw any treatment that the patients would normally receive. The patients' medical care will continue normally under the CICU doctors' supervision.

The participants will be monitored during their hospitalization in the CICU, during their hospitalization in the 2nd Department of Cardiology of the UHI after their discharge from CICU, as well as for the next 1-year in the Outpatients Clinic; if the latter is not feasible (in case of disability or distance) they will be contacted through telephone interviews.

Study Timeline

• Study Start: 2023-04-27
• Study First Submitted: 2023-07-10
• Status Verified: 2023-10
• Study First Submitted QC: 2023-10-06
• Last Update Submitted: 2023-10-06
• Study First Posted: 2023-10-13
• Last Update Posted: 2023-10-13
• Primary Completion: 2026-04-26
• Study Completion: 2027-04-26

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• All patients admitted to the Cardiac Intensive Care Unit (CICU) through the Emergency Department of the UHI
• All patients transferred to the CICU from other hospital departments or other regional secondary hospitals
• Patients with an acute cardiovascular disease that requires treatment in a CICU
• Patients who are under scientific supervision of the 2nd Department of Cardiology
• Patients (or their relative/legal representatives) that have signed the informed consent form

Exclusion Criteria

None

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
In-hospital mortality	During the index admission (up to 8 weeks)	In-hospital all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU
30-day mortality	30 days after discharge from hospital	30-day all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU
1-year mortality	1-year after discharge from hospital	1-year all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU

Secondary Outcome Measures

Name	Time	Method
In-hospital major adverse cardiac events (MACE)	During the index admission (up to 8 weeks)	In-hospital MACE of patients with acute cardiovascular disease that require treatment in a CICU
30-day major adverse cardiac events (MACE)	30 days after discharge from hospital	30-day MACE of patients with acute cardiovascular disease that require treatment in a CICU
1-year major adverse cardiac events (MACE)	1-year after discharge from hospital	1-year MACE of patients with acute cardiovascular disease that require treatment in a CICU

Trial Locations

Locations (1)

University Hospital of Ioannina; 🇬🇷 Ioannina, Epirus, Greece