幽门螺杆菌筛查预防急性心肌梗死患者胃肠道出血（HELP-MI SWEDEHEART）——一项基于注册登记的整群随机交叉临床试验的设计与原理
HELicobacter Pylori screening to prevent gastrointestinal bleeding in patients with acute Myocardial Infarction (HELP-MI SWEDEHEART) - Design and rationale of a cluster randomized, crossover, registry-based clinical trial.
作者信息
Hofmann Robin, James Stefan, Sundqvist Martin O, Wärme Jonatan, Fröbert Ole, Angerås Oskar, Hellström Per M, Hambraeus Kristina, Alfredsson Joakim, Erlinge David, Lauermann Jörg, Lindhagen Lars, Östlund Ollie, Jernberg Tomas, Bäck Magnus
机构信息
Department of Clinical Science and Education, Division of Cardiology, Karolinska Institutet, Södersjukhuset, Stockholm, Sweden.
Department of Medical Sciences, Cardiology, Uppsala University, Uppsala, Sweden; Uppsala Clinical Research Center, Uppsala University, Uppsala, Sweden.
出版信息
Am Heart J. 2025 Aug;286:66-74. doi: 10.1016/j.ahj.2025.03.014. Epub 2025 Mar 27.
BACKGROUND
The role of Helicobacter pylori (H. pylori) screening and eradication on reducing upper gastrointestinal bleeding (UGIB) complications after acute myocardial infarction (MI) is uncertain. The HELicobacter pylori screening to prevent gastrointestinal bleeding in patients with acute MI (HELP-MI SWEDEHEART) trial aims to determine whether systematic H. pylori screening compared to usual care reduces UGIB, mortality, and cardiovascular outcomes after MI.
METHODS
A cluster randomized, crossover, registry-based clinical trial using SWEDEHEART as trial platform for study population definition and source for data collection in combination with nationwide Swedish health data registries. Thirty-five Swedish hospitals, organized into 18 clusters based on percutaneous coronary intervention networks, were randomized to either routine H. pylori screening for adults with acute type-1 MI or usual care. After 1 year, a 2-month blanking period was followed by a crossover to the alternate allocation for 1 year. The trial enrolment was concluded after one additional year of registry-based follow-up. The primary endpoint is UGIB. Secondary endpoints include all-cause death, cardiovascular death, readmission for MI, stroke, or heart failure. Endpoints will be reported combined (Net Adverse Clinical Events; Major Adverse Cardiac or Cerebrovascular Events) and separately. The primary analysis will include all available follow-up time corresponding to a maximum follow-up time of 3 years and 2 months.
CONCLUSION
HELP-MI SWEDEHEART aims to determine the utility of routine H. pylori screening to reduce UGIB and improve cardiovascular outcomes after MI. By integrating national registry follow-up data with a pragmatic trial design, it has the potential to provide evidence for the effect of the implementation of routine H. pylori screening as part of acute MI care.
TRIAL REGISTRATION
ClinicalTrials.gov, NCT05024864.
背景
幽门螺杆菌（H. pylori）筛查及根除在降低急性心肌梗死（MI）后上消化道出血（UGIB）并发症方面的作用尚不确定。急性心肌梗死患者幽门螺杆菌筛查预防胃肠道出血（HELP-MI SWEDEHEART）试验旨在确定与常规治疗相比，系统性幽门螺杆菌筛查是否能降低MI后的UGIB、死亡率及心血管结局。
方法
一项基于瑞典心脏注册研究（SWEDEHEART）平台的整群随机、交叉、注册登记临床试验，用于定义研究人群及作为数据收集来源，并结合瑞典全国健康数据登记处。35家瑞典医院根据经皮冠状动脉介入网络分为18个群组，随机分为对急性1型MI成人进行常规幽门螺杆菌筛查组或常规治疗组。1年后，有2个月的空白期，随后交叉至另一组分配方案，为期1年。在基于注册登记的额外1年随访后结束试验入组。主要终点为UGIB。次要终点包括全因死亡、心血管死亡、MI再入院、中风或心力衰竭。终点将合并（净不良临床事件；主要不良心脏或脑血管事件）及分别报告。主要分析将包括对应最长3年2个月随访时间的所有可用随访时间。
结论
HELP-MI SWEDEHEART旨在确定常规幽门螺杆菌筛查在降低MI后UGIB及改善心血管结局方面的效用。通过将国家注册登记随访数据与务实的试验设计相结合，它有可能为将常规幽门螺杆菌筛查作为急性MI治疗一部分实施的效果提供证据。
试验注册
ClinicalTrials.gov，NCT05024864。
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