跳至主要内容
临床试验/NCT04289012
NCT04289012已完成不适用

HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in Patients With Acute Myocardial Infarction Pilot Study

Karolinska Institutet4 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2019年11月7日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
4
主要终点
Prevalence of Hp

研究概览

简要总结

The aim of this study is to determine the prevalence of Helicobacter pylori (Hp) infection in patients with myocardial infarction (MI). This is performed to establish the feasibility of a large trial examining whether systematic screening for and subsequent eradication therapy significantly reduces the risk of hospitalization for upper gastrointestinal (GI) bleeding in patients after MI.

详细描述

Despite progressively reduced mortality over the last decades, cardiovascular disease remains the most common cause of death in both men and women in Sweden and the world. In addition to early revascularization therapy, potent antithrombotic therapy is the basis for the reduction in cardiovascular events, however, at a price of increased risk of bleeding, typically upper gastrointestinal bleeding (UGIB) that result in substantial morbidity, mortality, and medical care cost. Risk factors for UGIB include high age, male sex, renal failure, and a chronic bacterial infection caused by Helicobacter pylori (Hp), the latter being the only treatable. H. pylori infection causes both acute and chronic gastritis with ulcerative and erosive lesions, peptic ulcer disease (both duodenal and gastric ulcers) and, less commonly, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. Concomitant anticoagulation or antithrombotic therapy aggravates the risk for bleeding, 2-fold with low dose aspirin, up to 7-fold with dual antiplatelet therapy, which today is standard treatment for 12 months post MI.

Non-invasive screening for Hp can be performed easily with high accuracy by urea breath or stool test. If found positive, eradication by triple therapy is well established and recommended in risk individuals and believed to reverse the bleeding risk almost completely.

Hp screening in a current MI population has to our knowledge never been performed. Thus, it remains unknown if systematic screening and subsequent eradication therapy significantly reduces the risk of bleeding and improves prognosis.

The HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction (HELP) pilot study is a multicenter, single group, open-label, clinical trial evaluating the prevalence of Hp in patients hospitalized with acute MI.

All patients at participating sites during the inclusion period, with MI diagnosis defined as International Classification of Diseases (ICD) codes I21 or I22, and age≥18 years, are eligible for enrollment. After written informed consent eligible patients will be tested for Hp infection with a bedside urea breath test (UBT) incorporated into MI routine care during the hospitalization period.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

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

  • Type 1 myocardial infarction (both STEMI and NSTEMI)

排除标准

  • Only concerning UBT (Patients after gastric surgery, with acute gastrointestinal bleeding, suspected gastric infection, or known atrophic gastritis).

结局指标

主要结局

Prevalence of Hp

时间窗: Baseline

Prevalence of Hp assessed by UBT

次要结局

  • Baseline characteristics according to Hp screening result(Baseline)
  • Baseline characteristics according to Hp screening result and infarct type(Baseline)
  • Baseline characteristics according to Hp screening result, infarct type and concomitant therapy(Baseline)
  • All-cause mortality(30 days)

研究者

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

Robin Hofmann

MD, PhD. Principal investigator.

Karolinska Institutet

研究点 (4)

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