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NCT Number: NCT06081205

Study of Patients Admitted to a Cardiac Intensive Care Unit With 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.

Recruiting

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Key information

Conditions

Cardiogenic Shock Acute Decompensated Heart Failure Acute Myocardial Infarction Acute Pulmonary Embolism Cardiovascular Diseases Heart Diseases Infarction Ischemia Myocardial Infarction Myocardial Ischemia Necrosis Pathologic Processes Pathological Conditions, Signs and Symptoms Shock Shock, Cardiogenic Vascular Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Other names: no further interventions

Primary outcomes

  1. In-hospital mortality

    Time frame: During the index admission (up to 8 weeks)

    In-hospital all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU

  2. 30-day mortality

    Time frame: 30 days after discharge from hospital

    30-day all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU

  3. 1-year mortality

    Time frame: 1-year after discharge from hospital

    1-year all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU

Secondary outcomes

  1. In-hospital major adverse cardiac events (MACE)

    Time frame: During the index admission (up to 8 weeks)

    In-hospital MACE of patients with acute cardiovascular disease that require treatment in a CICU

  2. 30-day major adverse cardiac events (MACE)

    Time frame: 30 days after discharge from hospital

    30-day MACE of patients with acute cardiovascular disease that require treatment in a CICU

  3. 1-year major adverse cardiac events (MACE)

    Time frame: 1-year after discharge from hospital

    1-year MACE of patients with acute cardiovascular disease that require treatment in a CICU

Study contacts

Contact information is provided by the study sponsor or research team.

Aidonis Rammos, MD

CONTACT

[email protected]

+30 26510 99111 ext. 347

Katerina K Naka, MD, PhD

CONTACT

[email protected]

+30 26510 99111 ext. 039

Sponsors and collaborators

Lead sponsor

University Hospital, Ioannina

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2026
Study completion
2027
First posted
Oct 13, 2023
Registry last updated
Oct 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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