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

Acute Myocardial Infarction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06081205
• Other study ID #: 10/270423
• Status: Recruiting
• Start date: April 27, 2023
• Est. completion date: April 26, 2027

Study information

• Verified date: October 2023
• Source: University Hospital, Ioannina
• Contact: Katerina K Naka, MD, PhD
• Phone: +30 26510 99111
• Email: anaka[@]uoi.gr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: April 26, 2027
• Est. primary completion date: April 26, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Decompensated Heart Failure
• Acute Myocardial Infarction
• Acute Pulmonary Embolism
• Cardiogenic Shock
• Cardiovascular Diseases
• Embolism
• Infarction
• Myocardial Infarction
• Pulmonary Embolism
• Shock, Cardiogenic

Intervention

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.

Locations

Country	Name	City	State
Greece	University Hospital of Ioannina	Ioannina	Epirus

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Ioannina

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	In-hospital mortality	In-hospital all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU	During the index admission (up to 8 weeks)
Primary	30-day mortality	30-day all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU	30 days after discharge from hospital
Primary	1-year mortality	1-year all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU	1-year after discharge from hospital
Secondary	In-hospital major adverse cardiac events (MACE)	In-hospital MACE of patients with acute cardiovascular disease that require treatment in a CICU	During the index admission (up to 8 weeks)
Secondary	30-day major adverse cardiac events (MACE)	30-day MACE of patients with acute cardiovascular disease that require treatment in a CICU	30 days after discharge from hospital
Secondary	1-year major adverse cardiac events (MACE)	1-year MACE of patients with acute cardiovascular disease that require treatment in a CICU	1-year after discharge from hospital