Congenital Heart DiseaseNCT03850223
Clinical Audit On Management Of Congenital Heart Disease In ACUH
An observational study of Congenital Heart Disease, run by Assiut University.
Trial summary
Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic… Read more about this study
- Who is it for?
- Ages 1 month to 18 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2020to 1 Dec 2021
- 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 1 month to 18 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: Children with congenital heart disease more than one month and less than 18 years
Who may be able to join
- children with CHD more than one month
Who cannot join
- children with CHD less than one month
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Clinical Audit On Management Of Congenital Heart Disease In Assiut Children University Hospital
Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.
Read the detailed description
CHD may be defined as an anatomic malformation of the heart or great vessels which occurs during intrauterine development, irrespective of the age at presentation. The cause of most congenital heart defects is still unknown. Many cases of congenital heart disease are multifactorial and result from a combination of genetic predisposition and an environmental stimulus. A small percentage of congenital heart lesions are related to known chromosomal abnormalities, in particular, trisomy 21, 13, and 18 and Turner syndrome. Of all cases of congenital heart disease, 2-4% are associated with known environmental or adverse maternal conditions and teratogenic influences, including maternal diabetes mellitus, phenylketonuria, systemic lupus erythematosus or congenital rubella syndrome; and maternal ingestion of drugs (lithium, ethanol, warfarin, antimetabolites, vitamin A derivatives, anticonvulsant agents).
- Conditions
- Congenital Heart Disease
- Medical subject headings
- Heart Defects, Congenital
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical audit study to assess management of congenital heart disease in AUCH
To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start1 Mar 2020 (estimated)
- Primary completion1 Oct 2021 (estimated)
- Study completion1 Dec 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fadwa Magdy Mohamed Abdou, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03850223
- Sponsor's protocol ID
- MOCHD
- Status last verified
- Feb 2020
- First submitted
- 20 Feb 2019
- Last updated
- 24 Feb 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit On Management Of Congenital Heart Disease In Assiut Children University Hospital
- ClinicalTrials.gov ID
- NCT03850223
- Acronym / sponsor ID
- MOCHD
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Mar 2020 (estimated)
- Primary completion
- 1 Oct 2021 (estimated)
- Study completion
- 1 Dec 2021 (estimated)
- First posted
- 21 Feb 2019 (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.
Congenital Heart Disease (CHD) is the most common birth defect in the United States, affecting approximately 0.8% of live births. Improved treatment strategies and interventions have increased survival such that 85% to 90% of affected children are expected to live well into adulthood, thereby causing a demographic shift in which adults now outnumber children with CHD, and more people with complex CHD are living longer.
Detailed description
CHD may be defined as an anatomic malformation of the heart or great vessels which occurs during intrauterine development, irrespective of the age at presentation. The cause of most congenital heart defects is still unknown. Many cases of congenital heart disease are multifactorial and result from a combination of genetic predisposition and an environmental stimulus. A small percentage of congenital heart lesions are related to known chromosomal abnormalities, in particular, trisomy 21, 13, and 18 and Turner syndrome. Of all cases of congenital heart disease, 2-4% are associated with known environmental or adverse maternal conditions and teratogenic influences, including maternal diabetes mellitus, phenylketonuria, systemic lupus erythematosus or congenital rubella syndrome; and maternal ingestion of drugs (lithium, ethanol, warfarin, antimetabolites, vitamin A derivatives, anticonvulsant agents).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Children with congenital heart disease more than one month and less than 18 years
Key inclusion criteria (1 listed)
- children with CHD more than one month
Key exclusion criteria (1 listed)
- children with CHD less than one month
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
Clinical audit study to assess management of congenital heart disease in AUCH
Time frame: One year
To assess how much the adopted protocol of management of congenital heart disease is implemented in Assiut university children hospital
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2020.
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, 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 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 24 Feb 2020. 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 Mostafa Shafeek Khalaf, Professor (+201112110096, mostafa.tawfeek1@med.au.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical audit study to assess management of congenital heart disease in AUCH (time frame: One 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 24 Feb 2020; AzTrials last refreshed its copy on 8 Nov 2026.