Journal Article

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

Östlund, Ollie, Lauermann, Jörg, Hambraeus, Kristina, Angerås, Oskar, James, Stefan, Sundqvist, Martin O., Bäck, Magnus, Jernberg, Tomas, Alfredsson, Joakim, Erlinge, David, Hofmann, Robin, Wärme, Jonatan, Hellström, Per M., Lindhagen, Lars, Fröbert, Ole

2025

Overview

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. 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. 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. ClinicalTrials.gov, NCT05024864.

• Publisher: Elsevier Inc,Elsevier Limited
• Subject: Aged / Aspirin / Bacterial infections / Blanking / Bleeding / Cardiology / Cardiology and Cardiovascular Disease / Cardiovascular diseases / Cerebral infarction / Clinical Medicine / Clinical trials / Cluster randomized crossover trial / Clusters / Congestive heart failure / Cross-Over Studies / Data collection / Death / Female / Gastrointestinal Hemorrhage - epidemiology / Gastrointestinal Hemorrhage - etiology / Gastrointestinal Hemorrhage - prevention & control / Heart attacks / Helicobacter Infections - complications / Helicobacter Infections - diagnosis / Helicobacter Infections - drug therapy / Helicobacter Infections - epidemiology / Helicobacter pylori / Helicobacter pylori - isolation & purification / Hemorrhage / Hospitals / Humans / Kardiologi och kardiovaskulära sjukdomar / Klinisk medicin / Male / Mass Screening - methods / Medical and Health Sciences / Medicin och hälsovetenskap / Middle Aged / Multicenter Studies as Topic / Myocardial infarction / Myocardial Infarction - complications / Observational studies / Patients / Percutaneous Coronary Intervention / Performance evaluation / Population studies / Pragmatic Clinical Trials as Topic / Randomized Controlled Trials as Topic / Randomized Registry-based Clinical Trial / Registries / Sweden - epidemiology / Upper gastrointestinal bleeding