"Prevalence of Asymptomatic Helicobacter Pylori Infection Among Patients Undergoing Percutaneous Coronary Intervention and Impact of Its Eradication on Occurrence of Gastrointestinal Symptoms and Bleeding"
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- GIT symptoms
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
GIT symptoms
时间窗: 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
次要结局
未报告次要终点
研究者
Rania Abdelaaty
Assistant Lecturer
Beni-Suef University