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

Summary

Background: Potent antithrombotic therapy has improved prognosis for patients with acute myocardial infarction (MI) significantly, however, at a price of increased bleeding risk. Helicobacter pylori (H. pylori) infection commonly causes upper gastrointestinal bleeding (UGIB). If systematic screening for H. pylori significantly reduces the risk of UGIB and improves outcomes is unknown.

Study design: A cluster randomized, cross-over, registry-based clinical trial using nationwide Swedish registries for study population definition and data collection.

Population: Patients discharged alive after hospitalization for acute type 1 MI at up to 40 hospitals across Sweden.

Regional PCI networks comprise 18 clusters. Clusters will be randomized to routine H. pylori screening or no screening for 1 year after which cross-over to the opposite strategy occurs for 1 year. The study ends after one additional year of registry-based follow-up, one year after the end of the second period.

Intervention: All MI patients will routinely be offered screening for H. pylori by urea breath test.

Controls: Standard clinical practice. Data will be collected from SWEDEHEART and national registries.

For patients testing H. pylori positive, eradication therapy will be prescribed at the caring physician's discretion. The individual implementation of H. pylori screening, test result and eradication therapy prescription will be recorded in SWEDEHEART. All follow-up data is collected from SWEDEHEART and national registries.

Outcome: Primary outcome is UGIB defined as hospitalization or an outpatient visit in specialized care with ICD codes corresponding to UGIB.

The secondary endpoints (in hierarchical) order:

1. Net Adverse Clinical Events (NACE): All-cause death, UGIB, hospitalization for MI, or hospitalization for ischemic stroke.
2. Major Adverse Cardiovascular and Cerebrovascular Events (MACCE): CV death, hospitalization for MI, or hospitalization for ischemic stroke.
3. All-cause death.
4. CV death.
5. Hospitalization for MI.
6. Hospitalization for stroke.
7. Hospitalization for HF.
8. UGIB requiring blood transfusion.

Conditions

• Myocardial Infarction
• Helicobacter Pylori Infection
• GastroIntestinal Bleeding
• Cardiovascular Diseases

Interventions

DIAGNOSTIC_TEST

Urea breath test (UBT)

After fasting for six hours prior to testing, the patient swallows a C13 Urea tablet or solution and waits. After 10 minutes, the patient exhales and breath is collected (breath bag). The production of 13CO2 is measured by a desktop analyzer (infrared mass spectrometry) and active H. pylori infection diagnosis is made based on previously established cut-off levels for H. pylori infection. In patients tested positive, eradication therapy according to the national society of gastroenterology guidelines will be prescribed at the caring physician's discretion. Control of successful H. pylori eradication 6 weeks after completed eradication therapy is recommended to the treating physician. During the period without H. pylori screening, the study´s UBT equipment will not be available.

Sponsors & Collaborators

• Region Stockholm

  collaborator OTHER_GOV

• The Swedish Research Council

  collaborator OTHER_GOV

• Hjärt-Lungfonden, Sweden

  collaborator UNKNOWN

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Robin Hofmann, MD, PhD · Karolinska Institutet, Department of Clinical Science and Education, Södersjukhuset, Stockholm.

Study Design

Allocation

RANDOMIZED

Purpose

SCREENING

Masking

SINGLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-11-17

Primary Completion

2025-01-17

Completion

2030-01-17

Countries

• Sweden

Study Locations