NCT06081205

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

A Prospective Observational Study of Patients Admitted to a Cardiac Intensive Care Unit Due to Acute CardioVascular Disease.

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 1,000 (estimated)
• Sponsor: University Hospital, Ioannina · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Cardiogenic Shock
• Acute Decompensated Heart Failure
• Acute Pulmonary Embolism
• Acute Myocardial Infarction

Interventions

Type	Name	Description
OTHER	Admission in the Cardiac Intensive Care Unit (CICU)	all patients admitted in the CICU will be enrolled in the study provided they give their informed consent.

Timeline

• Start date: 2023-04-27
• Primary completion: 2026-04-26
• Completion: 2027-04-26
• First posted: 2023-10-13
• Last updated: 2023-10-13

Locations

1 site across 1 country: Greece