PericarditisNCT03253315
Management of Pericarditis in Children.
An observational study of Pericarditis, run by Assiut University at 1 site in Egypt.
Trial summary
The pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. Read more about this study
- Who is it for?
- Ages 12 months to 18 years
- Conditions the study is for
- Pericarditis
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- Sep 2017to Apr 2019
- How long will I take part?
- 15 Days
- 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 12 months to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: patients who above one year of age up to 18 years diagnosed with pericarditis and/or pericardial effusions are candidates for the study.
Who may be able to join
- Children with pericarditis and/or pericardial effusion above one year of age detected clinically and by echocardiography
Who cannot join
- children below one year of age. - children with malignant effusion.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut
nagwa ali, MD, 01096260950, namma65@yahoo.com
About this study
Official title: Clinical Audit of the Management of Pericarditis in Children.
The pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the heart to the mediastinum, gives protection against infection and provides lubrication for the heart. Pericardial diseases may be either isolated disease or part of a systemic disease Diseases of the pericardium present clinically in one of several ways
- Acute and recurrent pericarditis
- Pericardial effusion without major hemodynamic compromise
- Cardiac tamponade with cardiac compromise
- Constrictive pericarditis
Read the detailed description
- Pericarditis usually present with chest pain and dyspnea. Effusion can present with no symptoms, dull ache in left chest and abdominal pain Cardiac tamponade is recognized by the excessive fall of systolic blood pressure
- Diagnostic workup A) Chest X-ray:_ chest X-ray can detect varying degree of cardiomegaly. B) Echocardiography: It is the first-line imaging test. clinically, two-dimensional echocardiography with Doppler provides the most cost-effective way of diagnosing C) Electrocardiograph D) cardiac computerized tomography :- Also may be helpful 4)Therapy of pericarditis in pediatrics the medical lines of treatment of pericarditis are:_ A)Aspirin and non-steroidal anti-inflammatory:_ are the mainstay of the therapy of inflammatory pericardial diseases B)Steroids: a minority of patients will require treatment with systemic steroid therapy as
- Patients with symptoms refractory to standard therapy
- Acute pericarditis due to connective tissue disease ●Uremic pericarditis C)Immunosuppressant and biological drugs (more commonly used in recurrent pericarditis) .Interventional therapeutic techniques-_
Most patients with acute pericarditis can be managed effectively with medical therapy alone. However, patients may require invasive therapies for:
- A moderate to large pericardial effusion, particularly if hemodynamically significant.
- Frequent, highly symptomatic recurrences of acute pericarditis with pericardial effusion ●Evidence of constrictive pericarditis (a late occurrence when present) A)Pericardial drainage :Prolonged catheter drainage of a pericardial effusion is an effective means of preventing fluid reaccumulation.
B)Pericardiotomy, pericardial window and pericardiectomy: pericardiectomy may be considered for frequent and highly symptomatic recurrences of pericarditis tamponade .. C)Surgical decompression of the pericardium :_can be achieved either by conventional heart surgery or video-assisted thoracoscopy.
- Conditions
- Pericarditis
- Medical subject headings
- Pericarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Echocardiographic signs
- normal cardiac size by echocardiography (measurable by echocardiographic probe)
- normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)
Measured: one month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Aug 2017
- Study startSep 2017 (estimated)
- Primary completionSep 2018 (estimated)
- Study completionApr 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PericarditisStudies 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
- Other
- Time perspective
- Other
- Enrolment
- 20 participants (estimated)
- Target duration
- 15 Days
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, aya gomaa mohamed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03253315
- Sponsor's protocol ID
- ayafadl24791
- Status last verified
- Aug 2017
- First submitted
- 7 Aug 2017
- Last updated
- 17 Aug 2017
- 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 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit of the Management of Pericarditis in Children.
- ClinicalTrials.gov ID
- NCT03253315
- Acronym / sponsor ID
- ayafadl24791
- Conditions
- Pericarditis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Sep 2017 (estimated)
- Primary completion
- Sep 2018 (estimated)
- Study completion
- Apr 2019 (estimated)
- First posted
- 17 Aug 2017 (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 pericardium is a double-walled sac containing the heart and the roots of the great vessels. The pericardial sac has two layers, a serous visceral l layer (also known as epicardium when it comes into contact with the myocardium) and a fibrous parietal layer. It encloses the pericardial cavity, which contains pericardial fluid. The pericardium fixes the heart to the mediastinum, gives protection against infection and provides lubrication for the heart. Pericardial diseases may be either isolated disease or part of a systemic disease Diseases of the pericardium present clinically in one of several ways
- Acute and recurrent pericarditis
- Pericardial effusion without major hemodynamic compromise
- Cardiac tamponade with cardiac compromise
- Constrictive pericarditis
Detailed description
- Pericarditis usually present with chest pain and dyspnea. Effusion can present with no symptoms, dull ache in left chest and abdominal pain Cardiac tamponade is recognized by the excessive fall of systolic blood pressure
- Diagnostic workup A) Chest X-ray:_ chest X-ray can detect varying degree of cardiomegaly. B) Echocardiography: It is the first-line imaging test. clinically, two-dimensional echocardiography with Doppler provides the most cost-effective way of diagnosing C) Electrocardiograph D) cardiac computerized tomography :- Also may be helpful 4)Therapy of pericarditis in pediatrics the medical lines of treatment of pericarditis are:_ A)Aspirin and non-steroidal anti-inflammatory:_ are the mainstay of the therapy of inflammatory pericardial diseases B)Steroids: a minority of patients will require treatment with systemic steroid therapy as
- Patients with symptoms refractory to standard therapy
- Acute pericarditis due to connective tissue disease ●Uremic pericarditis C)Immunosuppressant and biological drugs (more commonly used in recurrent pericarditis) .Interventional therapeutic techniques-_
Most patients with acute pericarditis can be managed effectively with medical therapy alone. However, patients may require invasive therapies for:
- A moderate to large pericardial effusion, particularly if hemodynamically significant.
- Frequent, highly symptomatic recurrences of acute pericarditis with pericardial effusion ●Evidence of constrictive pericarditis (a late occurrence when present) A)Pericardial drainage :Prolonged catheter drainage of a pericardial effusion is an effective means of preventing fluid reaccumulation.
B)Pericardiotomy, pericardial window and pericardiectomy: pericardiectomy may be considered for frequent and highly symptomatic recurrences of pericarditis tamponade .. C)Surgical decompression of the pericardium :_can be achieved either by conventional heart surgery or video-assisted thoracoscopy.
Study design
- Observational model
- Other
- Time perspective
- Other
- Target follow-up
- 15 Days
Who may qualify
- Ages
- 12 months to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- patients who above one year of age up to 18 years diagnosed with pericarditis and/or pericardial effusions are candidates for the study.
Key inclusion criteria (1 listed)
- Children with pericarditis and/or pericardial effusion above one year of age detected clinically and by echocardiography
Key exclusion criteria (1 listed)
- children below one year of age. - children with malignant effusion.
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
Echocardiographic signs
Time frame: one month
1. normal cardiac size by echocardiography (measurable by echocardiographic probe) 2. normal thickening of pericardium by echocardiography .(measurable by echocardiographic probe)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2017.
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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.
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 Pericarditis, 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 17 Aug 2017. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Echocardiographic signs (time frame: one 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 17 Aug 2017.