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

American Heart Journal, Journal Year: 2025, Volume and Issue: unknown

Published: March 1, 2025

The role of Helicobacter pylori (H. pylori) screening and eradication on reducing upper gastrointestinal bleeding (UGIB) complications after acute myocardial infarction (MI) is uncertain. HELicobacter Pylori to prevent in patients with MI (HELP-MI SWEDEHEART) trial aims determine whether systematic H. compared usual care reduces UGIB, mortality, cardiovascular outcomes MI. A cluster randomized, crossover, registry-based clinical using SWEDEHEART as platform for study population definition source data collection combination nationwide Swedish health registries. Thirty-five hospitals, organized into 18 clusters based percutaneous coronary intervention networks, were randomized either routine adults type-1 or care. After one year, a 2-month blanking period was followed by crossover the alternate allocation year. enrolment concluded additional year follow-up. primary endpoint UGIB. Secondary endpoints include all-cause death, readmission MI, stroke, heart failure. Endpoints will be reported combined (Net Adverse Clinical Events; Major Cardiac Cerebrovascular Events) separately. analysis all available follow-up time corresponding maximum 3 years 2 months. HELP-MI utility reduce UGIB improve By integrating national registry pragmatic design, it has potential provide evidence effect implementation part ClinicalTrials.gov, NCT05024864.

Language: Английский

Reply to ‘Screening for Helicobacter pylori infection in patients with cardiovascular and gastrointestinal disease’

Nature Reviews Cardiology, Journal Year: 2024, Volume and Issue: 21(8), P. 594 - 595

Published: May 2, 2024

Language: Английский

Seroprevalence of Helicobacter pylori and incident myocardial infarction - A population-based Swedish nested case–control study

International Journal of Cardiology, Journal Year: 2024, Volume and Issue: unknown, P. 132917 - 132917

Published: Dec. 1, 2024

Language: Английский