MACENCT07136831
"Short-term Outcome in STEMI Patients Undergoing Primary PCI: A Comparative Study Between Rural and Urban Communities at Assiut University."
An observational study of MACE and In STEMI, run by Assiut University.
Trial summary
this study aims to assess the short-term (3-month) clinical and echocardiographic outcomes of primary PCI among STEMI patients from rural versus urban areas in Upper Egypt. A special focus will be placed on identifying predictors of MACE. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- What is being tested?
- Primary Percutaneous Coronary Intervention (PPCI)
- Type of treatment
- Medical device
- How many people
- 162 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2025to 30 Dec 2026
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Study population: patients Confirmed diagnosis of ST-segment elevation myocardial infarction (STEMI) based on ECG and cardiac biomarkers.
Who may be able to join
- 1. Adults aged ≥18 years. 2. Confirmed diagnosis of ST-segment elevation myocardial infarction (STEMI) based on ECG and cardiac biomarkers.
- 3. Underwent primary percutaneous coronary intervention (PCI) within the study period.
- 4. Known and verified residential address classified as rural or urban based on official definitions (e.g., UK or WHO classification).
- 5. Informed consent obtained
Who cannot join
- Non-STEMI or unstable angina cases.
- Patients who received fibrinolytic therapy instead of PCI.
- Transfer from another facility after more than 12 hours of symptom onset.
- Patients with previous revascularization (e.g., CABG or PCI within the last 6 months).
- Incomplete clinical data or unknown residential location.
- -
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: "Short-term Outcome of Patients From Rural Versus Urban Communities Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction"
this study aims to assess the short-term (3-month) clinical and echocardiographic outcomes of primary PCI among STEMI patients from rural versus urban areas in Upper Egypt. A special focus will be placed on identifying predictors of MACE. The findings may offer valuable insight into optimizing STEMI care pathways and support the development of regional STEMI networks across Egypt.
Read the detailed description
ST-segment elevation myocardial infarction (STEMI) is a life-threatening condition that requires urgent reperfusion therapy, with primary percutaneous coronary intervention (PCI) being the gold standard of care. While PCI significantly reduces complications and improves survival, access to this intervention remains unequal, particularly between rural and urban populations
According to the latest census definitions, a rural area is characterized by:A population of fewer than 5,000,A population density of less than 400 persons per square kilometer,And more than 25% of the male working population engaged in agriculture.
Rural patients often experience delayed diagnosis, limited access to PCI-capable centers, and prolonged ischemic times. These factors contribute to poorer clinical outcomes, including higher rates of reinfarction, heart failure, and mortality. In contrast, urban residents typically have faster access to specialized cardiac care and more efficient treatment pathways.
In Upper Egypt, this urban-rural gap is particularly pronounced, with rural patients facing substantial logistical and systemic challenges in receiving timely PCI. Although efforts have been made to expand PCI access nationwide, there remains a lack of localized data comparing short-term outcomes-particularly major adverse cardiovascular events (MACE)-between rural and urban STEMI patients.
- Being tested
- Primary Percutaneous Coronary Intervention (PPCI)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Percutaneous Coronary Intervention (PPCI)Device
A catheter-based invasive procedure used to open blocked coronary arteries in patients presenting with ST-elevation myocardial infarction (STEMI).
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of major adverse cardiovascular events (MACE) among STEMI patients undergoing primary percutaneous coronary intervention (PCI),
Unite of measurement : Number of patients experiencing MACE (% of total)
Measured: 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2025
- Study start15 Aug 2025 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion30 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MACEStudies of the same condition, open and under way.
- More trials run by Assiut 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
- 162 participants (estimated)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fatma Ali Khallaf, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07136831
- Sponsor's protocol ID
- STEMI-PPCI-RURALURBAN-ASU25
- Status last verified
- Aug 2025
- First submitted
- 28 Jul 2025
- Last updated
- 22 Aug 2025
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Short-term Outcome of Patients From Rural Versus Urban Communities Undergoing Primary Percutaneous Coronary Intervention for ST-Elevation Myocardial Infarction"
- ClinicalTrials.gov ID
- NCT07136831
- Acronym / sponsor ID
- STEMI-PPCI-RURALURBAN-ASU25
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Aug 2025 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 30 Dec 2026 (estimated)
- First posted
- 22 Aug 2025 (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 assess the short-term (3-month) clinical and echocardiographic outcomes of primary PCI among STEMI patients from rural versus urban areas in Upper Egypt. A special focus will be placed on identifying predictors of MACE. The findings may offer valuable insight into optimizing STEMI care pathways and support the development of regional STEMI networks across Egypt.
Detailed description
ST-segment elevation myocardial infarction (STEMI) is a life-threatening condition that requires urgent reperfusion therapy, with primary percutaneous coronary intervention (PCI) being the gold standard of care. While PCI significantly reduces complications and improves survival, access to this intervention remains unequal, particularly between rural and urban populations
According to the latest census definitions, a rural area is characterized by:A population of fewer than 5,000,A population density of less than 400 persons per square kilometer,And more than 25% of the male working population engaged in agriculture.
Rural patients often experience delayed diagnosis, limited access to PCI-capable centers, and prolonged ischemic times. These factors contribute to poorer clinical outcomes, including higher rates of reinfarction, heart failure, and mortality. In contrast, urban residents typically have faster access to specialized cardiac care and more efficient treatment pathways.
In Upper Egypt, this urban-rural gap is particularly pronounced, with rural patients facing substantial logistical and systemic challenges in receiving timely PCI. Although efforts have been made to expand PCI access nationwide, there remains a lack of localized data comparing short-term outcomes-particularly major adverse cardiovascular events (MACE)-between rural and urban STEMI patients.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients Confirmed diagnosis of ST-segment elevation myocardial infarction (STEMI) based on ECG and cardiac biomarkers.
Key inclusion criteria (4 listed)
- 1. Adults aged ≥18 years. 2. Confirmed diagnosis of ST-segment elevation myocardial infarction (STEMI) based on ECG and cardiac biomarkers.
- 3. Underwent primary percutaneous coronary intervention (PCI) within the study period.
- 4. Known and verified residential address classified as rural or urban based on official definitions (e.g., UK or WHO classification).
- 5. Informed consent obtained
Key exclusion criteria (6 listed)
- Non-STEMI or unstable angina cases.
- Patients who received fibrinolytic therapy instead of PCI.
- Transfer from another facility after more than 12 hours of symptom onset.
- Patients with previous revascularization (e.g., CABG or PCI within the last 6 months).
- Incomplete clinical data or unknown residential location.
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 |
|---|---|---|
| Primary Percutaneous Coronary Intervention (PPCI)A catheter-based invasive procedure used to open blocked coronary arteries in patients presenting with ST-elevation myocardial infarction (STEMI). | Device | – |
Primary outcome
Incidence of major adverse cardiovascular events (MACE) among STEMI patients undergoing primary percutaneous coronary intervention (PCI),
Time frame: 3 month
Unite of measurement : Number of patients experiencing MACE (% of total)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 2025.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of MACE and In STEMI, run by Assiut 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 4 inclusion and 6 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: opening soon, as of the sponsor's last update on 22 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Fatma ali khallaf Dr fatma ali (+201000465132, blsmakn6@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of major adverse cardiovascular events (MACE) among STEMI patients undergoing primary percutaneous coronary intervention (PCI), (time frame: 3 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Aug 2025.