Pharmacological and Mechanical Support Approaches in the Management of Acute Heart Failure in the Regional Network Model for the Management of Cardiogenic Shock

NCT06827314 | Recruiting

• 1 other identifier: Shock-ER
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Cardiogenic Shock; Acute Coronary Event

Outcome Measures

Primary Outcomes (9)

• 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

  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

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.

  5 years

• Comparison of survival between patients who underwent HRT as a consequence of CS to elective patients in the study period

  5 years

• Description of in-hospital complications such as rate of renal replacement therapy, number of nosocomial infections with therapy and consequent associated mortality.

  5 years

• Description of MCS-related complications, including bleeding requiring transfusions, vascular complications including bleeding requiring intervention and limb ischemia.

  5 years

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• CS following cardiac surgery (post-cardiotomy), ● Significant polytrauma or neurological injury.

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead

Study Sites (1)

IRCCS Azienda Ospedaliero-Universitaria di Bologna

Bologna, Bologna, 40138, Italy

RECRUITING

MeSH Terms

Conditions

Shock, Cardiogenic

Condition Hierarchy (Ancestors)

Myocardial Infarction; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis; Shock

Study Officials

• Luciano G Potena, MD

  IRCCS Azienda Ospedaliero-Universitaria di Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Luciano Potena, MD

CONTACT

0512143725; scompenso.trapiantocuore@aosp.bo.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2025
• First Posted: February 14, 2025
• Study Start: December 6, 2022
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2027
• Last Updated: February 14, 2025

Record last verified: 2024-12

Locations

IT (1)