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

NCT ID: NCT06081205

Last Updated: 2023-10-13

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 1000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-04-27
• Study Completion Date: 2027-04-26

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.

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Interventions

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.

Intervention Type: OTHER

Other Intervention Names

no further interventions

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital, Ioannina

OTHER

Sponsor Role: lead

Responsible Party

Katerina Naka

Professor of Cardiology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Lampros K Michalis, MD, PhD

Role: STUDY_DIRECTOR

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

Locations

University Hospital of Ioannina

Ioannina, Epirus, Greece

Site Status: RECRUITING

Countries

Greece

Central Contacts

Katerina K Naka, MD, PhD

Role: CONTACT

anaka@uoi.gr

+30 26510 99111 ext. 039

Aidonis Rammos, MD

Role: CONTACT

aidrammos@yahoo.gr

+30 26510 99111 ext. 347

Facility Contacts

Aidonis Rammos, MD

Role: primary

aidrammos@yahoo.gr

+3026510 99111 ext. 347

Konstantinos Siaravas, MD

Role: backup

siaravaskon@gmail.com

+3026510 99111 ext. 863

Other Identifiers

10/270423

Identifier Type: -

Identifier Source: org_study_id