Acute Coronary SyndromeNCT05788055
Helicobacter Pylori Infection in Acute Myocardial Infarction Patients
An observational study of Acute Coronary Syndrome, run by Sohag University.
Trial summary
This study aims to investigate the association between H.Pylori and ACS . Read more about this study
- Who is it for?
- Ages 18 to 90 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Coronary Syndrome
- What is being tested?
- Stool Analysis
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2023to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: All patients presenting by acute coronary syndrome to Coronary Care Units and the chronic stable angina patients.
Who may be able to join
- All patients presenting by acute coronary syndrome to Coronary Care Units, Internal Medicine Department, Sohag Faculty of Medicine from 18 .
Who cannot join
- 1.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.
Trial locations and contacts
No sites are listed yet.
Lotfy H Abu Dahb, Prof contact
About this study
Official title: The Study of Helicobacter Pylori Infection in Acute Myocardial Infarction Patients
This study aims to investigate the association between H.Pylori and ACS .
Read the detailed description
The study is based on show the relationship between H.Pylori infection and Acute Coronary Syndrome .
Active H.Pylori infection is common in ACS and may represent a modifiable risk factor for upper gastrointestinal bleeding.
- Conditions
- Acute Coronary Syndrome
- Being tested
- Stool Analysis
- Medical subject headings
- Acute Coronary Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool AnalysisDiagnostic test
Stool Analysis to detect H.Pylori Antigen in Stool
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Diagnostic Test: Stool Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of results of H.Pylori antigen with ACS
Analysis of H.Pylori antigen and compare with ECG findings and cardiac enzymes
Measured: from the day of admission to the day of disharge of sohag university hospitals
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2023
- Study start1 Apr 2023 (estimated)
- Primary completion1 Oct 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Asmaa Ezz Mostafa, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788055
- Sponsor's protocol ID
- H.Pylori and AMI
- Status last verified
- Jan 2023
- First submitted
- 5 Mar 2023
- Last updated
- 28 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 25063740
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Study of Helicobacter Pylori Infection in Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT05788055
- Acronym / sponsor ID
- H.Pylori and AMI
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Apr 2023 (estimated)
- Primary completion
- 1 Oct 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 28 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to investigate the association between H.Pylori and ACS .
Detailed description
The study is based on show the relationship between H.Pylori infection and Acute Coronary Syndrome .
Active H.Pylori infection is common in ACS and may represent a modifiable risk factor for upper gastrointestinal bleeding.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Acute Coronary Syndrome Patients | – | Diagnostic Test: Stool AnalysisStool Analysis will be done for all cases to detect H.pylori Antigen and results will be analysed into infected patients and non infected patients. |
| Chronic Stable Angina Patients | – | Diagnostic Test: Stool AnalysisStool Analysis will be done for all cases to detect H.pylori Antigen and results will be analysed into infected patients and non infected patients. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- All patients presenting by acute coronary syndrome to Coronary Care Units and the chronic stable angina patients.
Key inclusion criteria (1 listed)
- All patients presenting by acute coronary syndrome to Coronary Care Units, Internal Medicine Department, Sohag Faculty of Medicine from 18 .
Key exclusion criteria (1 listed)
- 1.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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Stool AnalysisStool Analysis to detect H.Pylori Antigen in Stool | Diagnostic test | Acute Coronary Syndrome Patients, Chronic Stable Angina Patients |
Primary outcome
Comparison of results of H.Pylori antigen with ACS
Time frame: from the day of admission to the day of disharge of sohag university hospitals
Analysis of H.Pylori antigen and compare with ECG findings and cardiac enzymes
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Mar 2023.
- Background: PubMed 25063740Lai 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lotfy H Abu Dahb, Prof contact
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Sohag University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Asmaa E Mostafa (01025542005, asmaaezz@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Comparison of results of H.Pylori antigen with ACS (time frame: from the day of admission to the day of disharge of sohag university hospitals). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05788055, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Mar 2023.