Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHospital de Santa Cruz, Portugal
About this trial
The goal of this observational study is to evaluate the clinical outcomes and management approaches of cardiogenic shock throughout the years in adult patients admitted to a Cardiology Department. The main questions it aims to answer are:
* How have management strategies and clinical outcomes for cardiogenic shock evolved over time? * How do clinical, laboratory, and advanced hemodynamic monitoring parameters relate to patient survival and overall prognosis in this population?
Researchers will evaluate clinical data collected from 2017 onwards to see if therapeutic advancements and changes in clinical management over the years have led to improved patient survival and quality of care.
Participants will:
* Receive standard, routine medical care for cardiogenic shock as determined by their clinical team (no experimental interventions will be introduced). * Have their clinical, laboratory, and imaging data collected from hospital electronic records during their stay. * Be followed for up to 1 year after hospital admission to evaluate long-term survival and clinical outcomes.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Systolic blood pressure (SBP) <90 mmHg for ≥30 minutes, or
Requirement for vasopressors, inotropes, or mechanical circulatory support to maintain SBP ≥90 mmHg
Serum lactate >2 mmol/L
Acute kidney injury and/or oliguria
Disqualifiers
Age < 18 years.
Other primary etiologies of shock at presentation (e.g., hypovolemic, hemorrhagic, septic, obstructive shock due to acute pulmonary embolism, or anaphylactic shock).
Refusal to participate in the study (applicable only to the prospective cohort).
Trial population
The study population consists of adult patients admitted with cardiogenic shock. The population reflects a real-world, highly complex, and critically ill cohort comprising both a retrospective cohort (admitted from January 2017 onwards) and a prospective cohort consecutively enrolled at the center.
Trial design
Design model
Cohort
Time perspective
Other
Treatments tested in this trial
Not listed
Trial groups
800 Participants
are grouped into 1 trial groupGroup A: Cardiogenic Shock Registry Cohort
Trial outcomes
Primary outcomes
1
All-Cause Mortality at 30 days after admission
The proportion of patients presenting with cardiogenic shock who die from any cause during the first 30 days after admission
Time frame
From date of hospital admission to 30 days after admissionSecondary outcomes
1
All-Cause Mortality at 1 Year
The rate of all-cause mortality evaluated after the index admission. Survival status will be determined via electronic medical records or the national registry ("last seen alive" verification).
Time frame
At 1 year post-index admission.2
Incidence of Major Bleeding up to 30 days after admission
The proportion of patients experiencing major bleeding events up to 30 days after admission. Major bleeding is defined according to the Bleeding Academic Research Consortium (BARC) classification as Type 3 (including 3a, 3b, and 3c) or Type 5 (fatal bleeding).
Time frame
From date of hospital admission to 30 days after admission3
Incidence of 3-Point Major Adverse Cardiovascular Events (3P-MACE) at 30 days
Thrombotic/ischemic events are defined using the 3-point Major Adverse Cardiovascular Events (3P-MACE) composite, which includes cardiovascular death, non-fatal myocardial infarction, and non-fatal stroke at 30 days after admission.
Time frame
From date of hospital admission to 30 days after admissionOther outcomes
1
Rate of Long-term Ventricular Assist Device (LVAD) Implantation or Heart Transplantation
The percentage of patients transitioning to advanced, long-term therapeutic options, specifically durable Left Ventricular Assist Devices (LVAD, e.g., HeartMate 3) or undergoing heart transplantation as a bridge or destination therapy.
Time frame
Up to 1 year post-index admission.Sponsors and contacts
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Source ClinicalTrials.gov