ACS-COVID-19-AssiutNCT04691609
Assiut University Registry for ACS Patients During COVID-19 Pandemic
An observational study of ACS-COVID-19-Assiut, run by Assiut University at 1 site in Egypt.
Trial summary
To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- ACS-COVID-19-Assiut
- How many people
- 2,500 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2020to Sep 2023
- 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: ACS patients admitted to Assiut university heart hospital either male or female, young or old, COVID-19 confirmed, suspected or even excluded.
Who may be able to join
- Patients presenting with symptoms or ECG indicative of acute coronary syndrome admitted to Assiut heart hospital
Who cannot join
- The only exclusion criteria is refusal of the patient to participate in the study
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Samah ObiedAllah Fouad
Asyut, Resident
Amr Ahmed Yousef, professor, 01006554042, amryoussef111@yohoo.com
Ayman khairy Hassan, lecturer, 01094438055, aymankhairy11@gmail.com
About this study
To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic
Read the detailed description
In the face of the quickly evolving coronavirus disease 2019 (COVID-19) pandemic, many health-care systems around the globe have modified their routine management of patients presenting with acute cardiovascular emergencies including patients with ACS.A unifying theme in the new management strategies is the adoption of new restrictive measures to meet the challenges of increased risk of infection of health-care workers; limited numbers of beds, shortage of personal protective equipment (PPE), inadequate number of protected catheterization rooms; and the clinical overlap between ACS and COVID-19 infection in some of patients.
In developing countries, with an already strained health system due to economic problems, the situation is more challenging and needs the formulation of efficient protocols that can accommodate several medical and socioeconomic challenges.
Egypt, with an estimated population of 100 million, is facing exceptional challenges during the COVID-19 crisis. Because large scale use of polymerase chain reaction (PCR) test for SARS-CoV-2 in a large population is a problem, the prevalence of COVID-19 infection in Egypt is unknown. Furthermore, the supply of PPE falls far short of demands with lack of professionally protected cardiac catheterization rooms. With progression of the pandemic in such a large population, care of COVID-19 patients is expected to rapidly overwhelm the supplies, beds, and staff available in Egyptian hospitals.
The Cardiology Department in Assiut university hospital has revised the management protocols for ACS patients and implemented new management protocols both for patients with ST-segment elevation myocardial infarction (STEMI) and Non-ST-segment elevation acute coronary syndromes (NSTE-ACS).
- Conditions
- ACS-COVID-19-Assiut
What is being measured
The primary outcome is the main question the study is designed to answer.
Main Number, distribution and oucome of all ACS patients coming to Assiut heart hospital
Number, distribution and outcome of all ACS patients coming to Assiut heart hospital(as age, gender, risk factors of coronary artery diseases and their effect on incidence and progress of ACS )
Measured: about 1 year
Secondary outcomes (1)
To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic
To evaluate clinical symptoms and signs of COVID -19 and acute coronary syndrome(Type of ACS, type of intervention or treatment for each case,complications if peresent, COVID - 19 status and if it affects ACS patient or not and follow up after 3 months and 1 year)
Measured: about 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Dec 2020
- Study start1 Mar 2020
- Primary completionMar 2023 (estimated)
- Study completionSep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ACS-COVID-19-AssiutStudies 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
- Cross-sectional
- Enrolment
- 2,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samah ObiedAllah Fouad, Assiut University
- Investigators
- Ayman Khairy Hassan, Lecturer, Study director, aymankhairy11@gmail.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04691609
- Sponsor's protocol ID
- ACS in COVID-19 era
- Status last verified
- Dec 2020
- First submitted
- 21 Sep 2020
- Last updated
- 31 Dec 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assiut University Registry for ACS Patients During COVID-19 Pandemic
- ClinicalTrials.gov ID
- NCT04691609
- Acronym / sponsor ID
- ACS in COVID-19 era
- Conditions
- ACS-COVID-19-Assiut
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,500 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Sep 2023 (estimated)
- First posted
- 31 Dec 2020 (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.
To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic
Detailed description
In the face of the quickly evolving coronavirus disease 2019 (COVID-19) pandemic, many health-care systems around the globe have modified their routine management of patients presenting with acute cardiovascular emergencies including patients with ACS.A unifying theme in the new management strategies is the adoption of new restrictive measures to meet the challenges of increased risk of infection of health-care workers; limited numbers of beds, shortage of personal protective equipment (PPE), inadequate number of protected catheterization rooms; and the clinical overlap between ACS and COVID-19 infection in some of patients.
In developing countries, with an already strained health system due to economic problems, the situation is more challenging and needs the formulation of efficient protocols that can accommodate several medical and socioeconomic challenges.
Egypt, with an estimated population of 100 million, is facing exceptional challenges during the COVID-19 crisis. Because large scale use of polymerase chain reaction (PCR) test for SARS-CoV-2 in a large population is a problem, the prevalence of COVID-19 infection in Egypt is unknown. Furthermore, the supply of PPE falls far short of demands with lack of professionally protected cardiac catheterization rooms. With progression of the pandemic in such a large population, care of COVID-19 patients is expected to rapidly overwhelm the supplies, beds, and staff available in Egyptian hospitals.
The Cardiology Department in Assiut university hospital has revised the management protocols for ACS patients and implemented new management protocols both for patients with ST-segment elevation myocardial infarction (STEMI) and Non-ST-segment elevation acute coronary syndromes (NSTE-ACS).
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- ACS patients admitted to Assiut university heart hospital either male or female, young or old, COVID-19 confirmed, suspected or even excluded.
Key inclusion criteria (1 listed)
- Patients presenting with symptoms or ECG indicative of acute coronary syndrome admitted to Assiut heart hospital
Key exclusion criteria (1 listed)
- The only exclusion criteria is refusal of the patient to participate in the study
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Main Number, distribution and oucome of all ACS patients coming to Assiut heart hospital
Time frame: about 1 year
Number, distribution and outcome of all ACS patients coming to Assiut heart hospital(as age, gender, risk factors of coronary artery diseases and their effect on incidence and progress of ACS )
1 secondary outcome
To register pathological events occurring to all acute coronary syndrome patients coming to Assiut university heart hospital through one year during COVID- 19 pandemic
Time frame: about 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2020.
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.
Ayman Khairy Hassan, Lecturer study director
aymankhairy11@gmail.com
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of ACS-COVID-19-Assiut, run by Assiut University at 1 site in Egypt.
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 31 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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 Samah obiedallah Fouad, resident (01069612646, samahfouad847@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Main Number, distribution and oucome of all ACS patients coming to Assiut heart hospital (time frame: about 1 year). 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 31 Dec 2020.