NCT05788055

Brief Summary

This study aims to investigate the association between H.Pylori and ACS .

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2023

Shorter than P25 for all trials

Status
unknown

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

First Submitted

Initial submission to the registry

March 5, 2023

Completed
23 days until next milestone

First Posted

Study publicly available on registry

March 28, 2023

Completed
4 days until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2024

Completed
Last Updated

March 28, 2023

Status Verified

January 1, 2023

Enrollment Period

6 months

First QC Date

March 5, 2023

Last Update Submit

March 15, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Comparison of results of H.Pylori antigen with ACS

    Analysis of H.Pylori antigen and compare with ECG findings and cardiac enzymes

    from the day of admission to the day of disharge of sohag university hospitals

Study Arms (2)

Acute Coronary Syndrome Patients

Stool Analysis will be done for all cases to detect H.pylori Antigen and results will be analysed into infected patients and non infected patients.

Diagnostic Test: Stool Analysis

Chronic Stable Angina Patients

Stool Analysis will be done for all cases to detect H.pylori Antigen and results will be analysed into infected patients and non infected patients.

Diagnostic Test: Stool Analysis

Interventions

Stool AnalysisDIAGNOSTIC_TEST

Stool Analysis to detect H.Pylori Antigen in Stool

Acute Coronary Syndrome PatientsChronic Stable Angina Patients

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presenting by acute coronary syndrome to Coronary Care Units and the chronic stable angina patients.

You may qualify if:

  • All patients presenting by acute coronary syndrome to Coronary Care Units, Internal Medicine Department, Sohag Faculty of Medicine from 18 .

You may not qualify if:

  • Patients with Cardiogenic Shock. 2. Renal Impairment.(Creatinine Clearence \<60) 3. A known systemic inflammatory condition. 4.They had taken any antibiotics in the previous 1 months. 5.They had taken any proton pump inhibitors in previous 2 weeks. 6.Gastrointestinal Bleeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lai CY, Yang TY, Lin CL, Kao CH. Helicobacter pylori infection and the risk of acute coronary syndrome: a nationwide retrospective cohort study. Eur J Clin Microbiol Infect Dis. 2015 Jan;34(1):69-74. doi: 10.1007/s10096-014-2207-7. Epub 2014 Jul 26.

    PMID: 25063740BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Interventions

Occult Blood

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative Techniques

Central Study Contacts

Lotfy H Abu Dahb, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 5, 2023

First Posted

March 28, 2023

Study Start

April 1, 2023

Primary Completion

October 1, 2023

Study Completion

January 1, 2024

Last Updated

March 28, 2023

Record last verified: 2023-01