Cardiac DiseaseNCT03398187
Cardiac Catheterization in the Management of Pediatric Cardiac Patients at A.U.C.H.
An observational study of Cardiac Disease, run by Assiut University.
Trial summary
The aim of this study is to find out and record the indications for diagnostic catheterization as well as for interventional cardiac catheterization in A.U.C.H , and record the outcome in these cases. Read more about this study
- Who is it for?
- Ages 1 month to 18 years
- Conditions the study is for
- Cardiac Disease
- What is being tested?
- cardiac catheterization
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- Jan 2018to Feb 2019
- 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
- No healthy volunteers
- Child, Adult
Study population: all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital
Who may be able to join
- -all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital
Who cannot join
- cases not admitted for diagnostic or interventional cardiac catheterization
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Cardiac Catheterization in the Management of Pediatric Cardiac Patients at Assiut University Children Hospital ( A Descriptive Study)
The aim of this study is to find out and record the indications for diagnostic catheterization as well as for interventional cardiac catheterization in A.U.C.H , and record the outcome in these cases.
Read the detailed description
Cardiac catheterization is of two types:
diagnostic and interventional . There has been recent advances in these procedures.There is an over 10y experience at the pediatric cardiology unit in assiut University Children Hospital ( A.U.C.H ) catheterization department. The procedure usually follows other investigations used for evaluation of the pediatric cardiac patients e.g. chest X-ray , ECG and echocardiography.
The role of cardiac catheterization may be in the diagnosis of congenital cardiac anomalies as well as in the follow up of repair of some cardiac anomalies . On the other hand, the indications for interventional cardiac catheterization may be repair of Atrial septal defect, Transposition of great arteries palliation with balloon septostomy ,blood vessel dilatation e.g. aortic stenosis and coarctation of the aorta . In addition Patent ductus arteriosus closure and others may be done by the interventional cardiac catheterization.
- Conditions
- Cardiac Disease
- Being tested
- cardiac catheterization
- Medical subject headings
- Heart Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
cardiac catheterizationDevice
diagnostic and interventional cardiac catheterization
What is being measured
The primary outcome is the main question the study is designed to answer.
procedure time
duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case|)
Measured: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2018
- Study startJan 2018 (estimated)
- Primary completionJan 2019 (estimated)
- Study completionFeb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac 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
- Cross-sectional
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nermeen Ahmed Mahmoud Sayed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03398187
- Sponsor's protocol ID
- Cardiac Cath. at A.U.C.H.
- Status last verified
- Jan 2018
- First submitted
- 12 Dec 2017
- Last updated
- 17 Jan 2018
- 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 17 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac Catheterization in the Management of Pediatric Cardiac Patients at Assiut University Children Hospital ( A Descriptive Study)
- ClinicalTrials.gov ID
- NCT03398187
- Acronym / sponsor ID
- Cardiac Cath. at A.U.C.H.
- Conditions
- Cardiac Disease
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Jan 2018 (estimated)
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Feb 2019 (estimated)
- First posted
- 12 Jan 2018 (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.
The aim of this study is to find out and record the indications for diagnostic catheterization as well as for interventional cardiac catheterization in A.U.C.H , and record the outcome in these cases.
Detailed description
Cardiac catheterization is of two types:
diagnostic and interventional . There has been recent advances in these procedures.There is an over 10y experience at the pediatric cardiology unit in assiut University Children Hospital ( A.U.C.H ) catheterization department. The procedure usually follows other investigations used for evaluation of the pediatric cardiac patients e.g. chest X-ray , ECG and echocardiography.
The role of cardiac catheterization may be in the diagnosis of congenital cardiac anomalies as well as in the follow up of repair of some cardiac anomalies . On the other hand, the indications for interventional cardiac catheterization may be repair of Atrial septal defect, Transposition of great arteries palliation with balloon septostomy ,blood vessel dilatation e.g. aortic stenosis and coarctation of the aorta . In addition Patent ductus arteriosus closure and others may be done by the interventional cardiac catheterization.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 1 month to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital
Key inclusion criteria (1 listed)
- -all cases admitted for cardiac catheterization for diagnosis or intervention at Assiut University Children Hospital
Key exclusion criteria (1 listed)
- cases not admitted for diagnostic or interventional cardiac catheterization
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 |
|---|---|---|
| cardiac catheterizationdiagnostic and interventional cardiac catheterization | Device | – |
Primary outcome
procedure time
Time frame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case)
duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case|)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jan 2018.
- pediatric cardiac catheterization databasesLink 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. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Cardiac 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 17 Jan 2018. 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 Nermeen A sayed (01010253353, littleprincess.nermeen@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
procedure time (time frame: duration of the cardiac catheterization procedure (1-4 hours depending on complexity of case)). 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 17 Jan 2018.