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

NCT06081205 | Recruiting

• 1 other identifier: 10/270423
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

• In-hospital major adverse cardiac events (MACE)

  During the index admission (up to 8 weeks)

• 30-day major adverse cardiac events (MACE)

  30 days after discharge from hospital

• 1-year major adverse cardiac events (MACE)

  1-year after discharge from hospital

Interventions

Admission in the Cardiac Intensive Care Unit (CICU) OTHER

all patients admitted in the CICU will be enrolled in the study provided they give their informed consent.

Also known as: no further interventions

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Ioannina: lead

Study Sites (1)

University Hospital of Ioannina

Ioannina, Epirus, 45500, Greece

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Lampros K Michalis, MD, PhD

  Professor of Cardiology, Director of the 2nd Cardiology Department, University Hospital of Ioannina

  STUDY DIRECTOR

Central Study Contacts

Katerina K Naka, MD, PhD

CONTACT

+30 26510 99111; anaka@uoi.gr

Aidonis Rammos, MD

CONTACT

+30 26510 99111; aidrammos@yahoo.gr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Cardiology

Study Record Dates

• First Submitted: July 10, 2023
• First Posted: October 13, 2023
• Study Start: April 27, 2023
• Primary Completion: April 26, 2026
• Study Completion (Estimated): April 26, 2027
• Last Updated: October 13, 2023

Record last verified: 2023-10

Locations

GR (1)