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
Study context
- Population
- Adults with acute type-1 myocardial infarction (MI) at Swedish hospitalsThirty-five Swedish hospitals, organized into 18 clusters based on percutaneous coronary intervention networks
- Planned comparison
- Systematic H. pylori screening compared to usual care
- Primary endpoint
- Upper gastrointestinal bleeding (UGIB)
- Follow-up
- All available corresponding to a maximum of 3 years and 2 months
Methodological detailspragmatic trial design, SWEDEHEART as trial platform, nationwide Swedish health data registries, 35 Swedish hospitals in 18 clusters, design and rationale
- Pragmatic trial design
- SWEDEHEART as trial platform
- Nationwide Swedish health data registries
- 35 Swedish hospitals in 18 clusters
- Design and rationale
No results yet. This paper sets out the design of a trial; its results are to come.
Further findings
Secondary endpoints: 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.
- After 1 year, a 2-month blanking period was followed by a crossover to the alternate allocation for 1 year.
Original publication
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. Am Heart J. Published 27 March 2025. doi:10.
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