SyncopeNCT04575376
Clinical Audit on Evaluation of Patient With Syncope at Asssiut University Children Hospital
An observational study of Syncope, run by Assiut University.
Trial summary
Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital and correction of the defect that will be discovered. Read more about this study
- Who is it for?
- Ages 1 year to 18 years
- Conditions the study is for
- Syncope
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- Apr 2021to Oct 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 1 year to 18 years
- All sexes
- Child, Adult
Study population: Patients with syncope who will be admitted to Assiut University Children Hospital.
Who may be able to join
- all cases of syncope.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital and correction of the defect that will be discovered.
Read the detailed description
Definition Syncope is a transient loss of consciousness associated with inability to maintain postural tone followed by rapid and spontaneous recovery. (1)
Epidemiology About 30-50% of children have syncope at least once in their lives till adolescent period, most of them are girls, 9% is the rate of syncope in 15-17 years old adolescent group, and this rate increase to the end of adolescent period. (2)
Causes (3)
I_Neurally mediated syncope
- Neurocardiogenic (vasovagal)
- Emotional stress induced (pain, fear, blood phobia, etc.)
- Orthostatic stress induced
- Situational syncope
- Respiratory (cough, sneeze, laugh, head turning)
- Gastrointestinal stimulation (swallowing, defecation, postprandial)
- Post micturition
- Post exercise
- Others
- Carotid sinus syncope
- Glossopharyngeal and trigeminal neuralgia syncope II_Cardiogenic syncope
- Arrhythmias as Bradycardia: - sinus node dysfunction (including bradycardia/tachycardia syndrome) - atrioventricular conduction system disease Tachycardia: - supraventricular - ventricular
- Structural heart defects as acute myocardial infarction/ischaemia, hypertrophic cardiomyopathy, cardiac masses (atrial myxoma, tumours, etc.), pericardial disease /tamponade.
- Functional heart defects as prosthetic valve dysfunction, pulmonary hypertension.
- Vascular heart abnormalities as aortic stenosis, congenital anomalies of coronary arteries, pulmonary embolus, acute aortic dissection.
III_ Orthostatic hypotensive syncope
- Primary autonomic disorder
- Secondary autonomic disorder
- Drug-induced orthostatic hypotension
- Hypovolemia related IV_Postural orthostatic tachycardia syndrome V_Metabolic reasons of syncope
- Hypoglycemia
- Hypoxia
- Electrolyte imbalance VI_Psychogenic syncope
- Anxiety
- Panic attack
- Depression
- Somatization VII_Drug-induced syncope
- Antihypertensives, diuretics, barbiturates, tricyclic antidepressants, alcohol, antiarrhythmics, macrolides, antihistamines, antipsychotics, MAO inhibitors, levodopa, prazosin, benzodiazepines VIII_Airway obstruction induced syncope IX_Hyperventilation-induced syncope X_Neurologic Syncope
- Cerebrovascular diseases
- Increased intracranial pressure
- Migraine
Symptoms
- The prodrome is the most important aspect of the history.
- A warm or clammy sensation, nausea, light headedness or visual changes (e.g seeing spots, grey out, tunneling)are strongly suggestive of vasovagal syndrome, other symptoms include irritability, confusion, auditory changes or dyspnea.
- The absence of prodrome raise the suspicion of a possible cardiac cause. 85%of children with vasovagal syncope has a prodrome, wheras only 40% of those with cardiac condition had a prodromal symptoms.
Palpitation and chest pain have been related to pediatric cardiac cause of syncope.(4) vasovagal syncope might also produce complex movement which raise a suspicion of epilepsy.(5)
- Most syncope is vasovagal, which is benign and doesn't require extensive investigation. The position statement presents recommendation to encourage an efficient and cost effective deposition for the many patients with a benign cause of syncope and hightlight atypical or concerning clinical findings associated with other causes of transient loss of consciousness.
- The prodrome and cirumstances around which the event occurred are the most important aspect of the history.
- Syncope occurring midexertion suggest cardiac etiology. A family history includes sudden death in the young or from unknown causes or causes that might be suspected to be other than natural can be a red flag.
- ECG is the most frequently ordered test, but the yield is low, It's recommended when patient's history isn't suggestive of vasovagal syncope and other features suggestive of cardiac cause like absence of prodrome, midexertion and family history of early life sudden death or heart diseases, abnormal physical examination or a new medication with potential cardiac cardiotoxicity.(6)
- Conditions
- Syncope
- Medical subject headings
- Syncope
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical audit on evaluation of a child with syncope at Assiut University children Hospital
Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2020
- Study startApr 2021 (estimated)
- Primary completionOct 2023 (estimated)
- Study completionOct 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for SyncopeStudies 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
- Retrospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, MENazeer, Assiut University
- Investigators
- Zeinab Mohie El-deen, Professor, Study director, Asssiut Universityfaisal al_khateeb ahmed, Professor, Study director, Asssiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04575376
- Sponsor's protocol ID
- Syncope
- Status last verified
- Feb 2021
- First submitted
- 29 Sep 2020
- Last updated
- 21 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.
PubMed 25980576Johnsrude CL. Current approach to pediatric syncope. Pediatr Cardiol. 2000 Nov-Dec;21(6):522-31. doi: 10.1007/s002460010130.
PubMed 11050276Bayram AK, Pamukcu O, Per H. Current approaches to the clinical assessment of syncope in pediatric population. Childs Nerv Syst. 2016 Mar;32(3):427-36. doi: 10.1007/s00381-015-2988-8. Epub 2016 Jan 5.
PubMed 26732063Hurst D, Hirsh DA, Oster ME, Ehrlich A, Campbell R, Mahle WT, Mallory M, Phelps H. Syncope in the Pediatric Emergency Department - Can We Predict Cardiac Disease Based on History Alone? J Emerg Med. 2015 Jul;49(1):1-7. doi: 10.1016/j.jemermed.2014.12.068. Epub 2015 Mar 20.
PubMed 25802162Yilmaz S, Gokben S, Levent E, Serdaroglu G, Ozyurek R. Syncope or seizure? The diagnostic value of synchronous tilt testing and video-EEG monitoring in children with transient loss of consciousness. Epilepsy Behav. 2012 May;24(1):93-6. doi: 10.1016/j.yebeh.2012.02.006. Epub 2012 Mar 28.
PubMed 22459868
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Audit on Evaluation of Patient With Syncope at Asssiut University Children Hospital
- ClinicalTrials.gov ID
- NCT04575376
- Acronym / sponsor ID
- Syncope
- Conditions
- Syncope
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Apr 2021 (estimated)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Oct 2023 (estimated)
- First posted
- 5 Oct 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.
Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at Assiut University Children Hospital and correction of the defect that will be discovered.
Detailed description
Definition Syncope is a transient loss of consciousness associated with inability to maintain postural tone followed by rapid and spontaneous recovery. (1)
Epidemiology About 30-50% of children have syncope at least once in their lives till adolescent period, most of them are girls, 9% is the rate of syncope in 15-17 years old adolescent group, and this rate increase to the end of adolescent period. (2)
Causes (3)
I_Neurally mediated syncope
- Neurocardiogenic (vasovagal)
- Emotional stress induced (pain, fear, blood phobia, etc.)
- Orthostatic stress induced
- Situational syncope
- Respiratory (cough, sneeze, laugh, head turning)
- Gastrointestinal stimulation (swallowing, defecation, postprandial)
- Post micturition
- Post exercise
- Others
- Carotid sinus syncope
- Glossopharyngeal and trigeminal neuralgia syncope II_Cardiogenic syncope
- Arrhythmias as Bradycardia: - sinus node dysfunction (including bradycardia/tachycardia syndrome) - atrioventricular conduction system disease Tachycardia: - supraventricular - ventricular
- Structural heart defects as acute myocardial infarction/ischaemia, hypertrophic cardiomyopathy, cardiac masses (atrial myxoma, tumours, etc.), pericardial disease /tamponade.
- Functional heart defects as prosthetic valve dysfunction, pulmonary hypertension.
- Vascular heart abnormalities as aortic stenosis, congenital anomalies of coronary arteries, pulmonary embolus, acute aortic dissection.
III_ Orthostatic hypotensive syncope
- Primary autonomic disorder
- Secondary autonomic disorder
- Drug-induced orthostatic hypotension
- Hypovolemia related IV_Postural orthostatic tachycardia syndrome V_Metabolic reasons of syncope
- Hypoglycemia
- Hypoxia
- Electrolyte imbalance VI_Psychogenic syncope
- Anxiety
- Panic attack
- Depression
- Somatization VII_Drug-induced syncope
- Antihypertensives, diuretics, barbiturates, tricyclic antidepressants, alcohol, antiarrhythmics, macrolides, antihistamines, antipsychotics, MAO inhibitors, levodopa, prazosin, benzodiazepines VIII_Airway obstruction induced syncope IX_Hyperventilation-induced syncope X_Neurologic Syncope
- Cerebrovascular diseases
- Increased intracranial pressure
- Migraine
Symptoms
- The prodrome is the most important aspect of the history.
- A warm or clammy sensation, nausea, light headedness or visual changes (e.g seeing spots, grey out, tunneling)are strongly suggestive of vasovagal syndrome, other symptoms include irritability, confusion, auditory changes or dyspnea.
- The absence of prodrome raise the suspicion of a possible cardiac cause. 85%of children with vasovagal syncope has a prodrome, wheras only 40% of those with cardiac condition had a prodromal symptoms.
Palpitation and chest pain have been related to pediatric cardiac cause of syncope.(4) vasovagal syncope might also produce complex movement which raise a suspicion of epilepsy.(5)
- Most syncope is vasovagal, which is benign and doesn't require extensive investigation. The position statement presents recommendation to encourage an efficient and cost effective deposition for the many patients with a benign cause of syncope and hightlight atypical or concerning clinical findings associated with other causes of transient loss of consciousness.
- The prodrome and cirumstances around which the event occurred are the most important aspect of the history.
- Syncope occurring midexertion suggest cardiac etiology. A family history includes sudden death in the young or from unknown causes or causes that might be suspected to be other than natural can be a red flag.
- ECG is the most frequently ordered test, but the yield is low, It's recommended when patient's history isn't suggestive of vasovagal syncope and other features suggestive of cardiac cause like absence of prodrome, midexertion and family history of early life sudden death or heart diseases, abnormal physical examination or a new medication with potential cardiac cardiotoxicity.(6)
Study design
- Observational model
- Other
- Time perspective
- Retrospective
Who may qualify
- Ages
- 1 year to 18 years
- Sex
- All
- Age groups
- Child, Adult
- Study population
- Patients with syncope who will be admitted to Assiut University Children Hospital.
Key inclusion criteria (1 listed)
- all cases of syncope.
Key exclusion criteria (1 listed)
- -
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 on evaluation of a child with syncope at Assiut University children Hospital
Time frame: Baseline
Evaluation of commitment of resident physician to the guidelines as regard management of cases of syncope at 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 21 Feb 2021.
- Background: PubMed 25980576Sheldon RS, Grubb BP 2nd, Olshansky B, Shen WK, Calkins H, Brignole M, Raj SR, Krahn AD, Morillo CA, Stewart JM, Sutton R, Sandroni P, Friday KJ, Hachul DT, Cohen MI, Lau DH, Mayuga KA, Moak JP, Sandhu RK, Kanjwal K. 2015 heart rhythm society expert consensus statement on the diagnosis and treatment of postural tachycardia syndrome, inappropriate sinus tachycardia, and vasovagal syncope. Heart Rhythm. 2015 Jun;12(6):e41-63. doi: 10.1016/j.hrthm.2015.03.029. Epub 2015 May 14. No abstract available.
- Background: PubMed 11050276Johnsrude CL. Current approach to pediatric syncope. Pediatr Cardiol. 2000 Nov-Dec;21(6):522-31. doi: 10.1007/s002460010130.
- Background: PubMed 26732063Bayram AK, Pamukcu O, Per H. Current approaches to the clinical assessment of syncope in pediatric population. Childs Nerv Syst. 2016 Mar;32(3):427-36. doi: 10.1007/s00381-015-2988-8. Epub 2016 Jan 5.
- Background: PubMed 25802162Hurst D, Hirsh DA, Oster ME, Ehrlich A, Campbell R, Mahle WT, Mallory M, Phelps H. Syncope in the Pediatric Emergency Department - Can We Predict Cardiac Disease Based on History Alone? J Emerg Med. 2015 Jul;49(1):1-7. doi: 10.1016/j.jemermed.2014.12.068. Epub 2015 Mar 20.
- Background: PubMed 22459868Yilmaz S, Gokben S, Levent E, Serdaroglu G, Ozyurek R. Syncope or seizure? The diagnostic value of synchronous tilt testing and video-EEG monitoring in children with transient loss of consciousness. Epilepsy Behav. 2012 May;24(1):93-6. doi: 10.1016/j.yebeh.2012.02.006. Epub 2012 Mar 28.
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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.
Zeinab Mohie El-deen, Professor study director
Asssiut University
faisal al_khateeb ahmed, Professor study director
Asssiut University
Questions about this trial
What is this clinical trial studying?
An observational study of Syncope, 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 21 Feb 2021. 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 Merna Ezzat (01223554098, mernaezzat852456@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical audit on evaluation of a child with syncope at Assiut University children Hospital (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04575376, which also lists 5 linked publications.
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 21 Feb 2021.