Cardiogenic ShockNCT06827314
Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
An observational study of Cardiogenic Shock and Acute Coronary Event, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
Trial summary
The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiogenic Shock, Acute Coronary Event
- How many people
- 500 participants
- Where
- 1 siteItaly
- Study dates
- 6 Dec 2022to Nov 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: For the prospective cohort, study population consists of all consecutive patients diagnosed with CS and admitted to participating CICUs in the Emilia Romagna region. For the prospective cohort patients will be enrolled after study approval and until 31 December 2027. Patients will be enrolled upon admission or at the development of CS if already admitted. Retrospective data will be collected for five years, starting from January 1st 2018 until the starting date of the study.
Who may be able to join
- Adult patients (≥18 years old) admitted to a participating CICU with suspected CS of stage from C to E according to SCAI (Society of cardiovascular intervention)classification of cardiogenic shock.
- Signed informed consent.
Who cannot join
- CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna, Bologna, 40138
Luciano Potena, MD, 0512143725, scompenso.trapiantocuore@aosp.bo.it
About this study
The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. The main outcomes are:
- Incidence of cardiogenic shock (CS) over the total CICU admissions, CS-related in-hospital mortality and length of hospitalization, stratified by aetiologies, sex and age
- Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.
This is an observational study without intervention. Patients will be treated according to current clinical practice, according to physician judgment and data sheets of each drug used according to clinical practice.
Read the detailed description
This is a multicenter observational study with both a retrospective and a prospective cohort.
Study population will include all consecutive patients diagnosed with cardiogenic shock and admitted to the cardiac intensive care unit of the participating centers.
For the patients enrolled at IRCCS Azienda Ospedaliera-Universitaria di Bologna this study will involve a collaboration with UO Cardiologia.
For the retrospective cohort, patients will be selected based on ICD9 discharge codes and included if they fulfill inclusion criteria after review of hospital charts. The retrospective cohort will serve as a historical comparison regarding epidemiology, treatment strategies and survival.
Incidence and workload burden of CICU will be studied comparing the number of CS patients and the total number of admissions in the study period.
- Conditions
- Cardiogenic Shock, Acute Coronary Event
- Medical subject headings
- Shock, Cardiogenic
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age.
Incidence
Measured: 5 years
Length of hospitalization, stratified by aetiologies, sex and age.
Days
Measured: 5 years
CS-related in-hospital mortality stratified by aetiologies, sex and age.
Incidence
Measured: 5 years
Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.
Demography description
Measured: 5 years
Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward
Recovery from cardiogenic shock
Measured: 5 years
In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS).
In-hospital survival
Measured: 5 years
Rate and reason of unplanned re-hospitalizations within one month after primary discharge
Rate and reason of unplanned re-hospitalizations
Measured: 5 years
Workload burden will be estimated as the percentage of CS admission and the mean duration of CICU stay as compared to other admissions during study period
Workload burden
Measured: 5 years
Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort
Blood counts, ECG, oxygen saturation and respiratory monitoring.
Measured: 5 years
Secondary outcomes (4)
Rate of successful bridge to heart replacement therapy (heart transplant or LVAD implant) in patients potentially eligible (i.e. age < 71 years old) and transferred to IRCCS Policlinico S.Orsola hub center.
Rate of successful bridge to heart replacement therapy
Measured: 5 years
Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period
Comparison of survival
Measured: 5 years
Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.
Description of in-hospital complications
Measured: 5 years
Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.
Description of MCS-related complications
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Feb 2025
- Study start6 Dec 2022
- Primary completionNov 2027 (estimated)
- Study completionNov 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.
- More trials run by IRCCS Azienda Ospedaliero-Universitaria di BolognaThe sponsor's other registered studies.
- 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
- Other
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Luciano G Potena, MD, Principal investigator, IRCCS Azienda Ospedaliero-Universitaria di Bologna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06827314
- Sponsor's protocol ID
- Shock-ER
- Status last verified
- Dec 2024
- First submitted
- 9 Jan 2025
- Last updated
- 14 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock
- ClinicalTrials.gov ID
- NCT06827314
- Acronym / sponsor ID
- Shock-ER
- Conditions
- Cardiogenic Shock, Acute Coronary Event
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- IRCCS Azienda Ospedaliero-Universitaria di BolognaUniversity, hospital or other
- Study start
- 6 Dec 2022 (actual)
- Primary completion
- Nov 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Feb 2025 (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.
The goal of this observational study is to understand and describe the epidemiology of cardiogenic shock in Emilia Romagna with a specific focus on outcome stratified by aetiologies, sex and age. The main outcomes are:
- Incidence of cardiogenic shock (CS) over the total CICU admissions, CS-related in-hospital mortality and length of hospitalization, stratified by aetiologies, sex and age
- Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.
This is an observational study without intervention. Patients will be treated according to current clinical practice, according to physician judgment and data sheets of each drug used according to clinical practice.
Detailed description
This is a multicenter observational study with both a retrospective and a prospective cohort.
Study population will include all consecutive patients diagnosed with cardiogenic shock and admitted to the cardiac intensive care unit of the participating centers.
For the patients enrolled at IRCCS Azienda Ospedaliera-Universitaria di Bologna this study will involve a collaboration with UO Cardiologia.
For the retrospective cohort, patients will be selected based on ICD9 discharge codes and included if they fulfill inclusion criteria after review of hospital charts. The retrospective cohort will serve as a historical comparison regarding epidemiology, treatment strategies and survival.
Incidence and workload burden of CICU will be studied comparing the number of CS patients and the total number of admissions in the study period.
Study design
- Observational model
- Cohort
- Time perspective
- Other
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- For the prospective cohort, study population consists of all consecutive patients diagnosed with CS and admitted to participating CICUs in the Emilia Romagna region. For the prospective cohort patients will be enrolled after study approval and until 31 December 2027. Patients will be enrolled upon admission or at the development of CS if already admitted. Retrospective data will be collected for five years, starting from January 1st 2018 until the starting date of the study.
Key inclusion criteria (2 listed)
- Adult patients (≥18 years old) admitted to a participating CICU with suspected CS of stage from C to E according to SCAI (Society of cardiovascular intervention)classification of cardiogenic shock.
- Signed informed consent.
Key exclusion criteria (1 listed)
- CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age.
Time frame: 5 years
Incidence
Length of hospitalization, stratified by aetiologies, sex and age.
Time frame: 5 years
Days
CS-related in-hospital mortality stratified by aetiologies, sex and age.
Time frame: 5 years
Incidence
Epidemiology of patients admitted with CS, regarding age, gender, etiology and modality of presentation (acute or acute on chronic), echocardiographic and haemodynamic data, treatment strategy with inotropes and/or short-term MCS, cardiac arrest.
Time frame: 5 years
Demography description
Recovery from cardiogenic shock, defined as improvement to at least SCAI stage B or discharge from CICU to a step-down ward
Time frame: 5 years
Recovery from cardiogenic shock
In-hospital survival according to age, etiology, presentation (acute or acute on chronic) and modality of treatment (inotropes or MCS).
Time frame: 5 years
In-hospital survival
Rate and reason of unplanned re-hospitalizations within one month after primary discharge
Time frame: 5 years
Rate and reason of unplanned re-hospitalizations
Workload burden will be estimated as the percentage of CS admission and the mean duration of CICU stay as compared to other admissions during study period
Time frame: 5 years
Workload burden
Rate of adherence to several items and differences between older era (retrospective data) and prospective cohort
Time frame: 5 years
Blood counts, ECG, oxygen saturation and respiratory monitoring.
4 secondary outcomes
Rate of successful bridge to heart replacement therapy (heart transplant or LVAD implant) in patients potentially eligible (i.e. age < 71 years old) and transferred to IRCCS Policlinico S.Orsola hub center.
Time frame: 5 years
Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period
Time frame: 5 years
Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.
Time frame: 5 years
Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.
Time frame: 5 years
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 14 Feb 2025.
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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.
Luciano G Potena, MD principal investigator
IRCCS Azienda Ospedaliero-Universitaria di Bologna
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 Coronary Event, run by IRCCS Azienda Ospedaliero-Universitaria di Bologna at 1 site in Italy.
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 2 inclusion and 1 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 14 Feb 2025. 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 Italy. 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 Luciano Potena, MD (0512143725, scompenso.trapiantocuore@aosp.bo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age. (time frame: 5 years). The study lists 9 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 14 Feb 2025.