跳至主要内容
临床试验/NCT05800951
NCT05800951进行中(未招募)不适用

Can Escalation Reduce Acute Myocardial Infarction Mortality in Cardiogenic Shock (CERAMICS Study)

Henry Ford Health System31 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2022年7月22日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
124
试验地点
31
主要终点
Hospital discharge survival/survival at 30 days

研究概览

简要总结

The CERAMICS study is designed to more clearly delineate the current care of acute myocardial infarction with cardiogenic shock (AMICS) patients who are treated with mechanical circulatory support (MCS) devices in the United States with significant experience in MCS, all of whom have the capability of MCS escalation on-site. Study enrollment is targeted at 120 patients at 20 hospital sites, evaluating clinical outcomes, and focusing on outcomes MCS escalation decision making and ICU level management.

详细描述

The National Cardiogenic Shock Initiative (NCSI) was an initial step in helping to provide team based protocolized care in AMICS. Over the past 5 years, further evaluation and research has helped identify additional best practices that may contribute to further improving outcomes.

Vasopressors have been identified as being independently associated with worse outcomes and MCS escalation may lead to improvement. While sites participating in the NCSI were early adopters of MCS in AMICS, MCS escalation was open ended and dictated by variable local practice patterns. This contributed to the overall low rate of MCS escalation which occurred in NCSI.

Approximately 30-40% of patients with AMICS have concomitant right ventricular failure (RVF), which is associated with worse morality and may therefore benefit from consideration of early right ventricular mechanical circulatory support (RV-MCS) devices.

A total of 20 total sites will be accepted into the CERAMICS study with the goal of gathering data and outcomes of 120 patients treated at participating centers. The study is expected to collect data for approximately 2 years. Prior to joining the study, each site must have broad adoption of the NCSI treatment algorithm as the standard of care for AMICS among at least 80% of the interventional cardiologists who take STEMI call, as confirmed by the site principal investigator (PI).

It is critically important to track consecutive AMICS patients at each site to assess outcomes by identifying the total sample size treated and to help identify if there were particular biases regarding the use of MCS or escalation of MCS. We will also track survival to hospital discharge of those AMICS patients not treated with MCS via an exclusion form, as well as with patients treated with MCS including when care deviates from the study protocol.

研究设计

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

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

  • Diagnosis of acute AMI confirmed by a medical professional, with changes in serum biomarkers or evidence of ischemic EKG changes (STEMI or NSTEMI).
  • Cardiogenic Shock present as defined by the presence of 2 OR MORE of the following criteria prior to PCI:
  • Hypotension: systolic blood pressure ≤ 90mmHg at baseline (prior to PCI) or the use of inotropes or vasopressors to maintain SBP ≥ 90mmHg
  • Evidence of end organ hypoperfusion: elevated serum lactate levels (venous or arterial), cool extremities, oliguria/anuria
  • Hemodynamic criteria: Cardiac Index of < 2.2 L/min/m2 or a cardiac power output (CPO) of ≤ 0.6 watts
  • Patient underwent PCI within 12 hours of hospital presentation.
  • Exclusion Registry

排除标准

  • AMICS patients who meet any of the following study exclusion criteria will have a limited set of data collected via a single-page Patient Exclusion Form completed and submitted within 45 days of hospital discharge, which includes the reason for exclusion, date of index PCI, and assessment of patient survival to hospital discharge:
  • Evidence of Anoxic Brain Injury
  • Unwitnessed out of hospital cardiac arrest or any cardiac arrest in which return of spontaneous circulation (ROSC) is not achieved within 30 minutes
  • IABP placed prior to MCS
  • Septic, anaphylactic, hemorrhagic, and neurologic causes of shock
  • Non-ischemic causes of shock/hypotension (pulmonary embolism, pneumothorax, myocarditis, tamponade, etc.)
  • Active bleeding for which MCS is contraindicated
  • Recent major surgery for which MCS is contraindicated
  • Mechanical complications of AMI (acute ventricular septal defect (VSD) or acute papillary muscle rupture)
  • Known left ventricular thrombus for which MCS is contraindicated
  • Mechanical aortic prosthetic valve
  • Contraindication to intravenous systemic anticoagulation which precludes placement of MCS.

结局指标

主要结局

Hospital discharge survival/survival at 30 days

时间窗: Hospital discharge survival/survival at 30 days

Hospital discharge survival/survival at 30 days

次要结局

  • All-cause mortality at 1 year(All-cause mortality at 1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Mir Babar Basir

Director of the Acute Mechanical Circulatory Support Program and STEMI Programs

Henry Ford Health System

研究点 (31)

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