NCT04289012

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
300

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2019

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 7, 2019

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 23, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 28, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 8, 2020

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 30, 2020

Completed
Last Updated

January 12, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

February 23, 2020

Last Update Submit

January 11, 2021

Conditions

STEMI - ST Elevation Myocardial InfarctionNSTEMI - Non-ST Segment Elevation MI

Keywords

Acute myocardial infarctionNon-ST Segment Elevation MIST-Elevation Myocardial InfarctionDual antiplatelet therapyHelicobacter pyloriScreeningUpper gastrointestinal bleedingUrea breath test

Outcome Measures

Primary Outcomes (1)

  • Prevalence of Hp

    Prevalence of Hp assessed by UBT

    Baseline

Secondary Outcomes (4)

  • Baseline characteristics according to Hp screening result

    Baseline

  • Baseline characteristics according to Hp screening result and infarct type

    Baseline

  • Baseline characteristics according to Hp screening result, infarct type and concomitant therapy

    Baseline

  • All-cause mortality

    30 days

Study Arms (1)

Helicobacter Screening

EXPERIMENTAL

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

Interventions

Helicobacter Pylori screening by UBTDIAGNOSTIC_TEST

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.

Helicobacter Screening

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Type 1 myocardial infarction (both STEMI and NSTEMI)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Karolinska University Hospital Huddinge

Huddinge, 14157, Sweden

Location

Södersjukhuset

Stockholm, 11883, Sweden

Location

Related Publications (5)

  • Laine L. CLINICAL PRACTICE. Upper Gastrointestinal Bleeding Due to a Peptic Ulcer. N Engl J Med. 2016 Jun 16;374(24):2367-76. doi: 10.1056/NEJMcp1514257. No abstract available.

    PMID: 27305194RESULT

  • Sarri GL, Grigg SE, Yeomans ND. Helicobacter pylori and low-dose aspirin ulcer risk: A meta-analysis. J Gastroenterol Hepatol. 2019 Mar;34(3):517-525. doi: 10.1111/jgh.14539. Epub 2018 Dec 17.

    PMID: 30408229RESULT

  • Chan FK, Ching JY, Suen BY, Tse YK, Wu JC, Sung JJ. Effects of Helicobacter pylori infection on long-term risk of peptic ulcer bleeding in low-dose aspirin users. Gastroenterology. 2013 Mar;144(3):528-35. doi: 10.1053/j.gastro.2012.12.038. Epub 2013 Jan 16.

    PMID: 23333655RESULT

  • Malfertheiner P, Megraud F, O'Morain CA, Atherton J, Axon AT, Bazzoli F, Gensini GF, Gisbert JP, Graham DY, Rokkas T, El-Omar EM, Kuipers EJ; European Helicobacter Study Group. Management of Helicobacter pylori infection--the Maastricht IV/ Florence Consensus Report. Gut. 2012 May;61(5):646-64. doi: 10.1136/gutjnl-2012-302084.

    PMID: 22491499RESULT

  • Dzierzanowska-Fangrat K, Lehours P, Megraud F, Dzierzanowska D. Diagnosis of Helicobacter pylori infection. Helicobacter. 2006 Oct;11 Suppl 1:6-13. doi: 10.1111/j.1478-405X.2006.00423.x.

    PMID: 16925605RESULT

MeSH Terms

Conditions

ST Elevation Myocardial InfarctionNon-ST Elevated Myocardial InfarctionGastrointestinal Hemorrhage

Condition Hierarchy (Ancestors)

Myocardial InfarctionMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisGastrointestinal DiseasesDigestive System DiseasesHemorrhage

Study Officials

  • Robin Hofmann, MD, PhD

    Karolinska Institutet, Södersjukhuset

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD. Principal investigator.

Study Record Dates

First Submitted

February 23, 2020

First Posted

February 28, 2020

Study Start

November 7, 2019

Primary Completion

May 8, 2020

Study Completion

October 30, 2020

Last Updated

January 12, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

SE(2)