Cardiogenic ShockNCT06081205
Study of Patients Admitted to a Cardiac Intensive Care Unit With Acute CardioVascular Disease
An observational study of Cardiogenic Shock and Acute Decompensated Heart Failure, run by University Hospital, Ioannina at 1 site in Greece.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cardiogenic Shock, Acute Decompensated Heart Failure, Acute Pulmonary Embolism
- What is being tested?
- Admission in the Cardiac Intensive Care Unit (CICU)
- How many people
- 1,000 participants
- Where
- 1 siteGreece
- Study dates
- 27 Apr 2023to 26 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Greece1 site, 1 recruiting
- Recruiting
University Hospital of Ioannina
Ioannina, Epirus, 45500
Aidonis Rammos, MD, +3026510 99111 ext. 347, aidrammos@yahoo.gr
Konstantinos Siaravas, MD, +3026510 99111 ext. 863, siaravaskon@gmail.com
About this study
Official title: A Prospective Observational Study of Patients Admitted to a Cardiac Intensive Care Unit Due to 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.
Read the 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
- Being tested
- Admission in the Cardiac Intensive Care Unit (CICU)
- Medical subject headings
- Shock, Cardiogenic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Admission in the Cardiac Intensive Care Unit (CICU)Other
Also called no further interventions
all patients admitted in the CICU will be enrolled in the study provided they give their informed consent.
What is being measured
The primary outcome is the main question the study is designed to answer.
In-hospital mortality
In-hospital all-cause mortality of patients with acute cardiovascular disease that require treatment in a CICU
Measured: 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
Measured: 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
Measured: 1-year after discharge from hospital
Secondary outcomes (3)
In-hospital major adverse cardiac events (MACE)
In-hospital MACE of patients with acute cardiovascular disease that require treatment in a CICU
Measured: 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
Measured: 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
Measured: 1-year after discharge from hospital
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2023
- Study start27 Apr 2023
- Primary completion26 Apr 2026 (estimated)
- Study completion26 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiogenic ShockStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Ioannina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katerina Naka, University Hospital, Ioannina
- Investigators
- Lampros K Michalis, MD, PhD, Study director, Professor of Cardiology, Director of the 2nd Cardiology Department, University Hospital of Ioannina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06081205
- Sponsor's protocol ID
- 10/270423
- Status last verified
- Oct 2023
- First submitted
- 10 Jul 2023
- Last updated
- 13 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Study of Patients Admitted to a Cardiac Intensive Care Unit Due to Acute CardioVascular Disease.
- ClinicalTrials.gov ID
- NCT06081205
- Acronym / sponsor ID
- 10/270423
- Conditions
- Cardiogenic Shock, Acute Decompensated Heart Failure, Acute Pulmonary Embolism, Acute Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, IoanninaUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 26 Apr 2026 (estimated)
- Study completion
- 26 Apr 2027 (estimated)
- First posted
- 13 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Admission in the Cardiac Intensive Care Unit (CICU)Also: no further interventionsall patients admitted in the CICU will be enrolled in the study provided they give their informed consent. | Other | – |
Primary outcome
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
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
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
3 secondary outcomes
In-hospital major adverse cardiac events (MACE)
Time frame: During the index admission (up to 8 weeks)
30-day major adverse cardiac events (MACE)
Time frame: 30 days after discharge from hospital
1-year major adverse cardiac events (MACE)
Time frame: 1-year after discharge from hospital
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Lampros K Michalis, MD, PhD study director
Professor of Cardiology, Director of the 2nd Cardiology Department, University Hospital of Ioannina
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiogenic Shock and Acute Decompensated Heart Failure, run by University Hospital, Ioannina at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Katerina K Naka, MD, PhD (+30 26510 99111 ext. 039, anaka@uoi.gr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
In-hospital mortality (time frame: During the index admission (up to 8 weeks)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2023.