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.

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.

Study Overview

• Status: Recruiting
• Conditions: Acute Decompensated Heart Failure; Acute Myocardial Infarction; Cardiogenic Shock; Acute Pulmonary Embolism
• Intervention / Treatment: Other: Admission in the Cardiac Intensive Care Unit (CICU)

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 Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Katerina K Naka, MD, PhD; Phone Number: 039 +30 26510 99111; Email: anaka@uoi.gr
• Study Contact Backup: Name: Aidonis Rammos, MD; Phone Number: 347 +30 26510 99111; Email: aidrammos@yahoo.gr

Study Locations

• Greece
  • Epirus
    • Ioannina, Epirus, Greece, 45500
      • Recruiting
      • University Hospital of Ioannina
      • Contact: Aidonis Rammos, MD; Phone Number: 347 +3026510 99111; Email: aidrammos@yahoo.gr
      • Contact: Konstantinos Siaravas, MD; Phone Number: 863 +3026510 99111; Email: siaravaskon@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• 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

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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
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

Collaborators and Investigators

• Sponsor: University Hospital, Ioannina
• Investigators: Study Director: Lampros K Michalis, MD, PhD, Professor of Cardiology, Director of the 2nd Cardiology Department, University Hospital of Ioannina

Study record dates

Study Major Dates

• Study Start (Actual): April 27, 2023
• Primary Completion (Estimated): April 26, 2026
• Study Completion (Estimated): April 26, 2027

Study Registration Dates

• First Submitted: July 10, 2023
• First Submitted That Met QC Criteria: October 6, 2023
• First Posted (Actual): October 13, 2023

Study Record Updates

• Last Update Posted (Actual): October 13, 2023
• Last Update Submitted That Met QC Criteria: October 6, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Ischemia; Pathologic Processes; Necrosis; Myocardial Ischemia; Heart Diseases; Vascular Diseases; Respiratory Tract Diseases; Lung Diseases; Embolism and Thrombosis; Shock; Myocardial Infarction; Infarction; Cardiovascular Diseases; Embolism; Shock, Cardiogenic; Pulmonary Embolism
• Other Study ID Numbers: 10/270423

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No