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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Другое 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.

Первичные конечные точки

• In-hospital mortality [Срок оценки: During the index admission (up to 8 weeks)]
• 30-day mortality [Срок оценки: 30 days after discharge from hospital]
• 1-year mortality [Срок оценки: 1-year after discharge from hospital]

Вторичные конечные точки (3)

• In-hospital major adverse cardiac events (MACE) [Срок оценки: During the index admission (up to 8 weeks)]
• 30-day major adverse cardiac events (MACE) [Срок оценки: 30 days after discharge from hospital]
• 1-year major adverse cardiac events (MACE) [Срок оценки: 1-year after discharge from hospital]

Критерии участия

Критерии включения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Греция · 1 центр

• University Hospital of Ioannina — Ioannina

Идентификаторы

NCT: NCT06081205 · 10/270423

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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