NCT05412732Unknown不适用
Study for the Clinical Validation of a New Biomarker to Determine Predisposition to Infections in Patients With Acute Myocardial Infarction.
Instituto de Investigación Hospital Universitario La Paz1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年7月21日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- Clinical validation of the presence of elevated mitochondrial DNA levels as a prognostic biomarker of infection risk in AMI patients
研究概览
简要总结
Prospective biomedical research study
详细描述
The aim is to validate a new biomarker, based on the levels of DNAmit present in blood, to assess the predisposition of an individual to suffer an infection. To validate this hypothesis, the DNAmit levels of patients with myocardial infarction will be analysed and their relationship with the probability of these patients developing an infectious process or not.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who have suffered AMI or cardiorespiratory arrest after AMI, have been admitted to hospital within the first 24 hours of the event and are required to be admitted to any Critical Care Unit. In addition, one of the following criteria must be met:
- •Symptoms of cardiac ischaemia.
- •New ischaemic patterns in the ECG.
- •Development of pathological QW waves on the ECG.
- •Obvious suspicion or loss of myocardial viability or new abnormal motility regions in a pattern consistent with ischaemic pathology.
- •Intracoronary thrombus detected on angiography or autopsy.
- •They must be of legal age, have read the Patient Information Sheet (HIP) and have signed the Informed Consent (IC).
- •Depending on the group in which they are to be classified, patients must meet specific inclusion criteria:
- •Group A: Patients who have suffered MI (myocardial infarction), are in the CRITICAL UNIT and their DNAmit values are below 0.25-105 copies.
- •Group B: Patients who have suffered an MI, are in the CRITICAL UNIT and their mtDNA values are above 0.25-105 copies.
排除标准
- •Patients who meet any of the following criteria shall not be eligible for inclusion in the clinical trial:
- •Chronic inflammatory diseases
- •Transplantation of any organ (except cornea).
- •Patients receiving or who have received in the last 3 months anti-inflammatory, immunosuppressive or biological treatment targeting the immune system (TNF blockers, anakinra, rituximab, abatacept or tocilizumab), except NSAIDs and colchicine.
- •Patients with overt and/or severe immunocompromise
- •History of chronic kidney or liver disease (dialysis or creatinine clearance < 30%).
- •Decompensated diabetes
- •Active tumour process. Patients considered to be in complete remission may be included in the study.
- •Major surgical intervention (in the 3 MONTHS PRIOR to inclusion in the study).
- •Pregnancy, childbirth or breastfeeding in the last 3 months.
- •Symptomatic patients with type IV heart failure (NYHA).
- •Life expectancy of less than 3 months.
- •Long-term urinary catheter or vascular catheter wearers
结局指标
主要结局
Clinical validation of the presence of elevated mitochondrial DNA levels as a prognostic biomarker of infection risk in AMI patients
时间窗: 18-30 hours
Level of circulating DNAmit
次要结局
- To determine the relationship between ADNmit levels and infarct location(0-24 hours)
- To determine the relationship between ADNmit levels and GRACE Score(0-24 hours)
- To determine the relationship between ADNmit levels and Left Ventricular Ejection Fraction(0-24 hours)
- To determine the relationship between ADNmit levels and ultrasensitive troponin I(0-24 hours)
- Correlating mitochondrial DNA levels with the patient's "immune" tolerant status(18-30 hours)
研究者
研究点 (1)
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