An observational study in Cardiogenic Shock, Acute Decompensated Heart Failure and Acute Pulmonary Embolism, sponsored by University Hospital, Ioannina. Recruiting at 1 site in Greece. Per ClinicalTrials.gov, last updated 2023-10-13.
Sponsored by University Hospital, Ioannina · Observational
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.
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.
296 studies on the registry are indexed under Shock, Cardiogenic; 134 are open to participants now.
This study's planned enrollment of 1,000 is above the median of 200 across 155 observational studies indexed under Shock, Cardiogenic.
Browse Shock, Cardiogenic studies →University Hospital, Ioannina is the lead sponsor of 13 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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
Inclusion Criteria:
Exclusion Criteria: None
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
all patients admitted in the CICU will be enrolled in the study provided they give their informed consent.
Also known as: no further interventions
In-hospital mortality
In-hospital all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU
Time frame: 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
Time frame: 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
Time frame: 1-year after discharge from hospital
In-hospital major adverse cardiac events (MACE)
In-hospital MACE of patients with acute cardiovascular disease that require treatment in a CICU
Time frame: 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
Time frame: 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
Time frame: 1-year after discharge from hospital
Plan to share: Undecided
No publications or documents are linked to this record.
Started Apr 2023 (actual). Primary completion is estimated for Apr 2026, 35 months after the start.
Of 79 non-industry observational studies under Shock, Cardiogenic, half reached primary completion within 44 months of starting (the median), counting those still running; a quarter within 19. This study's planned 35 months is below that.
Counting every sponsor, half of 84 studies reached it within 45 months; a quarter within 24.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
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University Hospital, Ioannina