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临床试验/NCT07597291
NCT07597291招募中不适用

Cardiovascular Outcomes Registry in Cardiogenic SHOCK

Hospital de Santa Cruz, Portugal1 个研究点 分布在 1 个国家目标入组 800 人开始时间: 2026年6月10日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
800
试验地点
1

研究概览

简要总结

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.

详细描述

The Cardiovascular Outcomes Registry in Cardiogenic SHOCK (COR-SHOCK) is hybrid (retrospective and prospective), observational registry designed to evaluate the clinical performance, therapeutic management, and outcomes of patients presenting with cardiogenic shock (CS).

Contemporary CS management has evolved beyond correcting macro-hemodynamic parameters. CS is now recognized as a highly dynamic, systemic syndrome characterized by microvascular hypoperfusion, systemic inflammatory response syndrome (SIRS), endothelial dysfunction, and profound neurohormonal and metabolic derangements. To capture this complexity, the COR-SHOCK registry systematically integrates granular, real-world data reflecting these pathophysiological axes. This includes laboratory evaluation, and advanced invasive hemodynamic profiling via pulmonary artery catheterization (Swan-Ganz).

Registry Procedures and Quality Assurance Plan

To ensure high-quality data collection and compliance with scientific standards, the registry implements the following procedures:

  1. Quality Assurance (QA) Plan:

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Other

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiogenic shock according to the following criteria:
  • Cardiac disorder resulting in hypotension, defined as at least one of the following:
  • Systolic blood pressure (SBP) <90 mmHg for ≥30 minutes, or
  • Requirement for vasopressors, inotropes, or mechanical circulatory support to maintain SBP ≥90 mmHg
  • Evidence of tissue hypoperfusion, defined by the presence of at least one of the following:
  • Serum lactate >2 mmol/L
  • Acute kidney injury and/or oliguria
  • Acute hepatic injury
  • Cool or mottled extremities
  • Altered mental status
  • Clinical presentation judged to be primarily attributable to a cardiac etiology.

排除标准

  • 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).

研究组 & 干预措施

Cardiogenic Shock Registry Cohort

Adult patients admitted with a diagnosis of cardiogenic shock between January 2017 and the end of the prospective recruitment period. All patients receive contemporary, standard clinical management for cardiogenic shock as determined by the clinical team, with no experimental interventions. Clinical, laboratory, imaging, and advanced hemodynamic monitoring data are systematically collected from hospital records to evaluate clinical performance and outcomes over time.

研究者

发起方
Hospital de Santa Cruz, Portugal
申办方类型
Other
责任方
Principal Investigator
主要研究者

João Presume

MD

Hospital de Santa Cruz, Portugal

研究点 (1)

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