CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 300 enrolled
Drug / intervention
Helicobacter Pylori screening by UBTother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04289012
NCT04289012N/ACompleted
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HELicobacter Pylori Screening to Prevent Gastrointestinal Bleeding in Patients With Acute Myocardial Infarction Pilot Study

Karolinska Institutet·interventional·Posted Feb 28, 2020·Updated Jan 12, 2021

In Brief

A clinical study evaluating Helicobacter Pylori screening by UBT for STEMI - ST Elevation Myocardial Infarction and NSTEMI - Non-ST Segment Elevation MI. Completed, enrolled 300 participants across 2 sites.

Detailed Summary

The aim of this study is to determine the prevalence of Helicobacter pylori (Hp) infection in patients with myocardial infarction (MI). This is performed to establish the feasibility of a large trial examining whether systematic screening for and subsequent eradication therapy significantly reduces the risk of hospitalization for upper gastrointestinal (GI) bleeding in patients after MI.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSTEMI - ST Elevation Myocardial Infarction, NSTEMI - Non-ST Segment Elevation MI
CountriesSweden
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedFeb 28, 2020
Enrollment StartNov 7, 2019
Primary CompletionMay 8, 2020
Study CompletionOct 30, 2020
TodayJul 2, 2026
Enrollment to primary: 6 monthsPosted 6.3 years ago

Interventions

Helicobacter Pylori screening by UBTother

The UBT is based on the fact that Hp produces urease, which catalyzes the urea molecule into ammonia (NH3) and carbon dioxide (CO2). 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 (tube, bag or breath card). The production of 13CO2 is measured by a desktop analyzer (infrared mass spectrometry) and Hp diagnosis is made based on previously established cut-off levels for Hp infection.