Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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:
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.
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of CS over the total CICU admissions stratified by aetiologies, sex and age. | Incidence | 5 years |
| Length of hospitalization, stratified by aetiologies, sex and age. | Days | 5 years |
| CS-related in-hospital mortality stratified by aetiologies, sex and age. | Incidence | 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 | 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 | 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 | 5 years |
| Rate and reason of unplanned re-hospitalizations within one month after primary discharge | Rate and reason of unplanned re-hospitalizations | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | 5 years |
| Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Luciano Potena, MD | Contact | 0512143725 | scompenso.trapiantocuore@aosp.bo.it |
| Name | Affiliation | Role |
|---|---|---|
| Luciano G Potena, MD | IRCCS Azienda Ospedaliero-Universitaria di Bologna | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IRCCS Azienda Ospedaliero-Universitaria di Bologna | Recruiting | Bologna | Bologna | 40138 | Italy |
Not provided
Not provided
Not provided
Not provided
Workload burden |
| 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. | 5 years |
Comparison of survival |
| 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 | 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 | 5 years |
| ID | Term |
|---|---|
| D012770 | Shock, Cardiogenic |
| ID | Term |
|---|---|
| D009203 | Myocardial Infarction |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
| D007238 | Infarction |
| D007511 | Ischemia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009336 | Necrosis |
| D012769 | Shock |
Not provided
Not provided