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OpenTrials
Completed

NCT Number: NCT07487142

Prevalence of Asymptomatic H Pylori Infection Among Patients Undergoing PCI and Impact of Its Eradication on Occurrence of GIT Symptoms and Bleeding"

In the present study, the aim was to report the prevalence of positive H. pylori infection in an unselected population referred for coronary intervention and likely to required DAPT or DPI, also the study assessed impact of H. pylori eradication on occurrence of GI symptoms or bleeding during the follow up period.

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Key information

Conditions

H Pylori Infection

Age range

35 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Banī Suwayf

Banī Suwayf, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ischemic heart disease patients scheduled for percutaneous coronary intervention
  • divided according to positivity of H. pylori infection,without restriction as regard the acuity of the clinical presentation (unstable angina,NSTEMI, STEMI, and elective procedures included).
  • H pylori positive patient were subdivided according to eradication therapy intake

Exclusion criteria

  • Patients without the possibility of requiring DAPT or DPI post-procedure, such as those referred for diagnostic hemodynamic studies only, cardiac biopsy, or diagnostic angiography in anticipation of a surgical valve procedure, we excluded.
  • Patients with known gastrointestinal symptoms (e.g. Dyspepsia and vomiting),gastrointestinal bleeding(e.g.Heamtemesis and melena),Known to halve chronic gastritis, peptic ulcer or had upper GI endoscopy before or those who were diagnosed previously as H.pylori positive patients or received eradication therapy before

Treatment and study plan

BISMUTH TETRACYCLINE METRONIDAZOLE OMEPRAZOLE

Drug

PCI patients h pylori positive

Primary outcomes

  1. GIT symptoms

    Time frame: 6months

    We used a common Questionnaire for assessment of GIT symptoms and grading of its severity called(Evaluation of a Gastrointestinal Symptoms Questionnaire)

    Every symptom was assessed as regard it's duration,time of it's occurrence e.g. post prandial,daytime or nighttime and severity either none,mild,moderate,severe,very severe and unbearable Link of the questionnaire is attached https://www.researchgate.net/publication/6861419_Evaluation_of_a_Gastrointestinal_Symptoms_Questionnaire

Sponsors and collaborators

Lead sponsor

Beni-Suef University

Other

Registry information

Official study title

"Prevalence of Asymptomatic Helicobacter Pylori Infection Among Patients Undergoing Percutaneous Coronary Intervention and Impact of Its Eradication on Occurrence of Gastrointestinal Symptoms and Bleeding"

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Mar 23, 2026
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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