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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Study contacts

• Principal investigator: Alaide Chieffo, Prof — IRCCS San Raffaele Hospital
• Study coordinator: Alaide Chieffo, Prof
• Email: cecalaide@gmail.com
• Phone: +390226437331

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.