Pilot Italian Cardiogenic Shock Initiative

Launched by FONDAZIONE GISE ONLUS · Jun 25, 2024

Keywords

ClinConnect Summary

The Pilot Italian Cardiogenic Shock Initiative is a clinical trial aimed at understanding how a special protocol for treating patients with cardiogenic shock can help reduce the risk of death within 30 days of hospital admission. Cardiogenic shock occurs when the heart is unable to pump enough blood to meet the body’s needs, often following a heart attack. This study will involve multiple hospitals in the Turin and Milan areas, where patients will either be observed retrospectively using past health records or prospectively by enrolling new patients. The goal is to improve communication and collaboration between hospitals to ensure that patients receive timely and effective care.

To participate in this trial, patients must be at least 18 years old and have been diagnosed with cardiogenic shock due to a recent heart attack or heart failure. They will need to give consent, or have a family member give consent on their behalf if they are unable to do so. Participants can expect to be monitored for up to 30 days after being admitted to the hospital, with researchers tracking their health outcomes, including any complications or death. This study is not yet recruiting participants, but it aims to gather valuable insights that could enhance treatment for cardiogenic shock in the future.

Gender

ALL

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.