HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction Pilot Study (HELPpilot)

January 11, 2021 updated by: Robin Hofmann, Karolinska Institutet

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

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Despite progressively reduced mortality over the last decades, cardiovascular disease remains the most common cause of death in both men and women in Sweden and the world. In addition to early revascularization therapy, potent antithrombotic therapy is the basis for the reduction in cardiovascular events, however, at a price of increased risk of bleeding, typically upper gastrointestinal bleeding (UGIB) that result in substantial morbidity, mortality, and medical care cost. Risk factors for UGIB include high age, male sex, renal failure, and a chronic bacterial infection caused by Helicobacter pylori (Hp), the latter being the only treatable. H. pylori infection causes both acute and chronic gastritis with ulcerative and erosive lesions, peptic ulcer disease (both duodenal and gastric ulcers) and, less commonly, gastric cancer and mucosa-associated lymphoid tissue (MALT) lymphoma. Concomitant anticoagulation or antithrombotic therapy aggravates the risk for bleeding, 2-fold with low dose aspirin, up to 7-fold with dual antiplatelet therapy, which today is standard treatment for 12 months post MI.

Non-invasive screening for Hp can be performed easily with high accuracy by urea breath or stool test. If found positive, eradication by triple therapy is well established and recommended in risk individuals and believed to reverse the bleeding risk almost completely.

Hp screening in a current MI population has to our knowledge never been performed. Thus, it remains unknown if systematic screening and subsequent eradication therapy significantly reduces the risk of bleeding and improves prognosis.

The HELicobacter Pylori Screening in Patients With Acute Myocardial Infarction (HELP) pilot study is a multicenter, single group, open-label, clinical trial evaluating the prevalence of Hp in patients hospitalized with acute MI.

All patients at participating sites during the inclusion period, with MI diagnosis defined as International Classification of Diseases (ICD) codes I21 or I22, and age≥18 years, are eligible for enrollment. After written informed consent eligible patients will be tested for Hp infection with a bedside urea breath test (UBT) incorporated into MI routine care during the hospitalization period.

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.

In patients tested positive, standard triple eradication therapy according to the national society of gastroenterology guidelines will be prescribed at the caring physician's discretion.

Control of successful Hp eradication therapy according to guidelines with either UBT or Hp-antigen in feces 6 weeks after completed eradication therapy is recommended to the treating physician.

Baseline characteristics and data about the in-hospital period (medication, procedures, complications, laboratory results) will be collected from the Swedish Web System for Enhancement and Development of Evidence-based Care in Heart Disease Evaluated According to Recommended Therapies (SWEDEHEART) registry. For patients with acute MI, 106 variables are registered, including demographics, risk factors, past medical history, medical treatment before admission, electrocardiographic changes, echocardiography, biochemical markers, other clinical features and investigations, medical treatment in hospital, interventions, hospital outcome, discharge diagnoses and discharge-medications.

Primary objective of this pilot study is to determine the prevalence of Hp infection in patients with MI.

The secondary objective is to determine the feasibility of a large clinical trial on whether systematic screening for Hp and subsequent eradication therapy in patients after MI reduces UGIB and cardiovascular events.

The tertiary objective is to map if the cardiovascular risk profile differs in patients that are Hp negative and Hp positive, respectively.

All-cause death within 30 days will be obtained from the Swedish population registry, including the vital status of all Swedish residence. SWEDEHEART is linked to the Swedish population registry every month.

Study Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Huddinge, Sweden, 14157
        • Karolinska University Hospital Huddinge
      • Stockholm, Sweden, 11883
        • Södersjukhuset

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Type 1 myocardial infarction (both STEMI and NSTEMI)

Exclusion Criteria:

  • Only concerning UBT (Patients after gastric surgery, with acute gastrointestinal bleeding, suspected gastric infection, or known atrophic gastritis).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Helicobacter Screening
All patients with confirmed MI (both STEMI and NSTEMI) will be tested for Hp infection with bedside UBT.
Diagnostic test: Helicobacter Pylori screening by UBT
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of Hp
Time Frame: Baseline
Prevalence of Hp assessed by UBT
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Baseline characteristics according to Hp screening result
Time Frame: Baseline
Comparison of baseline characteristics according to Hp screening result (positive/negative)
Baseline
Baseline characteristics according to Hp screening result and infarct type
Time Frame: Baseline
Comparison of baseline characteristics according to Hp screening result (positive/negative) stratified by infarct type
Baseline
Baseline characteristics according to Hp screening result, infarct type and concomitant therapy
Time Frame: Baseline
Comparison of baseline characteristics according to Hp screening result (positive/negative) stratified by infarct type and concomitant therapy (PPI, antibiotics)
Baseline
All-cause mortality
Time Frame: 30 days
All-cause mortality in Hp screened Mi patients according to screening status
30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Karolinska Institutet

Investigators

  • Principal Investigator: Robin Hofmann, MD, PhD, Karolinska Institutet, Södersjukhuset

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 7, 2019

Primary Completion (ACTUAL)

May 8, 2020

Study Completion (ACTUAL)

October 30, 2020

Study Registration Dates

First Submitted

February 23, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HELP-MI pilot

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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