Clinical trial NCT06081205: Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease
Official title: A Prospective Observational Study of Patients Admitted to a Cardiac Intensive Care Unit Due to Acute CardioVascular Disease.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Cardiogenic Shock
Acute Decompensated Heart Failure
Acute Pulmonary Embolism
Acute Myocardial Infarction
Lead sponsor: University Hospital, Ioannina
Sponsor class: OTHER
First posted: 2023-10-13
Enrollment: 1000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients that are admitted through the Emergency Department of the UHI, transferred by other hospital clinics or by other regional secondary hospitals, with an acute cardiovascular disease that requires treatment in a CICU and are under scientific supervision of the 2nd Department of Cardiology, irrespectively of gender and age. In order to be enrolled, patients or their relative/legal representative (in cases stated above) must have signed an informed consent form

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.

Eligibility criteria: 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

Primary outcomes:
measure: In-hospital mortality
timeFrame: During the index admission (up to 8 weeks)
measure: 30-day mortality
timeFrame: 30 days after discharge from hospital
measure: 1-year mortality
timeFrame: 1-year after discharge from hospital
Secondary outcomes:
measure: In-hospital major adverse cardiac events (MACE)
timeFrame: During the index admission (up to 8 weeks)
measure: 30-day major adverse cardiac events (MACE)
timeFrame: 30 days after discharge from hospital
measure: 1-year major adverse cardiac events (MACE)
timeFrame: 1-year after discharge from hospital
Other outcomes:
Locations:
city: Ioannina
country: Greece
facility: University Hospital of Ioannina
state: Epirus
Study officials:
affiliation: Professor of Cardiology, Director of the 2nd Cardiology Department, University Hospital of Ioannina
name: Lampros K Michalis, MD, PhD
role: STUDY_DIRECTOR
References: