Italian pilot program to speed referral and care for cardiogenic shock patients

SPOKE-HUB SHOCK PROTOCOL MANAGEMENT ACCORDING TO SCAI CLASS IN TURIN AND MILAN AREA

This program will try a shared hub-and-spoke cardiogenic shock protocol to see if faster referral to specialized centers lowers 30-day deaths for adults with AMI-related cardiogenic shock (SCAI B–D).

Quick facts

• Study type: Observational
• Enrollment: 786 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fondazione GISE Onlus (other)
• Locations: 16 sites (Chivasso and 15 other locations)
• Trial ID: NCT06475456 on ClinicalTrials.gov

What this trial studies

This is a multicenter observational pilot using a hub-and-spoke model in the Turin and Milan metropolitan areas. It includes a retrospective cohort of anonymous electronic health record data from Jan 2016–Dec 2019 and a prospective cohort that will enroll consecutive AMI-related cardiogenic shock patients going forward, with a target of 384 patients per cohort (768 total). Four hub centers (each receiving patients from three spoke hospitals) and 12 spoke centers will share a dedicated cardiogenic shock protocol to improve communication and transfer timing. The main outcome is 30-day mortality after adoption of the protocol, with attention to timely use of pPCI and mechanical circulatory support at hub centers.

Who should consider this trial

Good fit: Adults (≥18) with acute myocardial infarction complicated by cardiogenic shock (SCAI class B–D) who are admitted to participating spoke hospitals in the Turin and Milan areas are the intended participants.

Not a fit: Patients whose shock is not caused by AMI, those treated outside the participating centers' catchment areas, or those too unstable or ineligible for transfer or specialized interventions are less likely to benefit.

Why it matters

Potential benefit: If successful, this approach could reduce 30-day deaths and get more patients to specialized centers for treatments like pPCI and percutaneous mechanical circulatory support.

How similar studies have performed: Standardized shock-team protocols and hub-and-spoke referral systems have improved outcomes in other acute conditions like STEMI and stroke, and preliminary data suggest similar approaches can reduce mortality in cardiogenic shock.

Eligibility criteria

Inclusion Criteria:

All subjects participating in this clinical trial must meet the following criteria:

Prospective cohort

* For conscious patients, signed and dated informed consent and consent to the processing of personal data
* For unconscious patients, informed consent signed and dated by the legal representative, or a proxy or a relative. The consent will be presented to the patient as soon the health conditions will improve. Aging ≥18

CS will be defined as:

1. Systolic blood pressure (SBP) \<90 mmHg or mean arterial pressure (MAP) \<60 mmHg, after an appropriate fluid challenge if there is no sign of overt fluid overload, OR need of vasoactive agents to maintain SBP \> 90 mmHg or MAP \> 60 mmHg, OR need of MCS;
2. At least one of the following criteria/signs of overt hypoperfusion: mixed venous oxygen saturation \<60%; arterial lactates \> 2 mmol/L; oliguria \< 0.5 ml/Kg/h for at least 6 hours.
3. CS following an acute myocardial infarction (AMICS) or acute decompensation of heart failure (ADHF-CS)

Exclusion Criteria:

Patients will be excluded if any of the following conditions apply:

1. Cardiac arrest with no quantifiable or longer than 10 minutes "no-flow" time or with refractory cardiac arrest (as defined by CPR prolonging for more than 20')
2. Absolute contraindication to support devices.
3. CS due to other aetiology apart from the ones in inclusion criteria as well as SCAI A and E before device positioning.
4. Age greater than 75-year-old
5. Life expectancy \< 1 year due to other reason than cardiogenic shock.

Where this trial is running

Chivasso and 15 other locations

• Ospedale di Chivasso — Chivasso, Italy (RECRUITING)
• ASL TO4 Ospedale di Ciriè — Cirié, Italy (RECRUITING)
• Ospedale Pio XI di Desio — Desio, Italy (RECRUITING)
• ASL Torino 4 Ospedale di Ivrea — Ivrea, Italy (RECRUITING)
• ASST Grande Ospedale Metropolitano Niguarda — Milan, Italy (RECRUITING)
• ASST Nord Milano — Milan, Italy (RECRUITING)
• IRCCS San Raffaele — Milan, Italy (RECRUITING)
• Ospedale San Carlo Borromeo — Milan, Italy (RECRUITING)
• Ospedale San Paolo — Milan, Italy (RECRUITING)
• ASL TO5 Ospedale Santa Croce — Moncalieri, Italy (RECRUITING)
• Presidio Ospedaliero di Rho — Rho, Italy (RECRUITING)
• Ospedale Civile SS. Annunziata — Savigliano, Italy (RECRUITING)
• AOU Città della Salute e della Scienza — Torino, Italy (RECRUITING)
• Azienda Sanitaria Locale "Città di Torino" Ospedale Maria Vittoria — Torino, Italy (RECRUITING)
• San Giovanni Bosco, ASL Città di Torino — Turin, Italy (RECRUITING)
• Ospedale di Vimercate — Vimercate, Italy (RECRUITING)

Study contacts

• Principal investigator: Alaide Chieffo, Prof — IRCCS San Raffaele Hospital
• Study coordinator: Alaide Chieffo, Prof

Conditions: Cardiogenic Shock, cardiogenic shock, SPOKE-HUB