Echo, ECG and Holter Findings After Fallot Repair in Children
9. juli 2026 opdateret af: Ahmed Fathy Ramdan, Sohag University
Echocardiographic, ECG and Holter Parameters in Pediatric Patients Post-surgical Fallot Repair
Aim of my study is to detect echocardiographic, ECG and Holter changes in children who have undergone surgical repair of Tetralogy of Fallot.
It is a retrospective observational study which will be conducted in Sohag university hospital.
Age group of patients included in the study varying from 1 day up to 25 years old.
Studieoversigt
Status
Ikke rekrutterer endnu
Intervention / Behandling
Detaljeret beskrivelse
Aim of my study is to detect echocardiographic, ECG and Holter changes in children who have undergone surgical repair of Tetralogy of Fallot.
This will be done by history taking of having chest pain , palpitations or any other cardiac symptoms then general and cardiac examination then performing 12-lead ECG and Holter ECG to detect any arrhythmias.
Echocardiography will be also done to detect presence of pulmonary or tricuspid regurgitation, ventricular dilatation or pulmonary stenosis.
The study is a retrospective observational study.
Age group of patients varying from 1 day up to 25 years old.
Undersøgelsestype
Observationel
Tilmelding (Anslået)
40
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Ahmed Fathy Ramadan Ali
- Telefonnummer: +201055811841
- E-mail: ah.fathi1379@gmail.com
Studiesteder
-
-
-
Sohag, Egypten
- Sohag University
-
Kontakt:
- Ahmed Fathy Ramadan Ali
- Telefonnummer: +201055811841
- E-mail: ah.fathi1379@gmail.com
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
N/A
Prøveudtagningsmetode
Sandsynlighedsprøve
Studiebefolkning
Children and adolescents up to 25 years old of both sexes who have undergone surgical repair of Tetralogy of Fallot and have no other medical diseases.
Beskrivelse
Inclusion Criteria:
- Children and adolescents up to age of 25 years old who have undergone surgical repair of Tetralogy of Fallot.
Exclusion Criteria:
- Ptients above age of 25 years.
- Children with other medical diseases.
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
QRS duration on 12-lead ECG in patients post Tetralogy of Fallot surgical repair
Tidsramme: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
QRS duration measured in milliseconds using a standard 12-lead electrocardiogram
|
Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
|
Corrected QT interval (QTc) on 12-lead ECG in patients post TOF surgical repair
Tidsramme: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
QTc is measured in milliseconds using standard 12-lead electrocardiogram to detect if it is prolonged or not.
|
Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
|
Presence and frequency of arrhythmias on Holter ECG in patients post TOF repair
Tidsramme: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Holter ECG helps in detection of arrhythmias as presence of ectopics
|
Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
|
Severity of pulmonary regurgitation by echocardiography in patients post TOF surgical repair
Tidsramme: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
|
|
Right ventricular function by echocardiography in patients post Tetralogy of Fallot surgical repair
Tidsramme: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Right ventricular contractility and enlargement measured by echocardiography to detect if patient is in heart failure or not.
|
Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
|
PR interval by 12-lead ECG in pediatric patients post Fallot surgical repair
Tidsramme: Data will be collected over 1 year period starting after after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Data will be collected over 1 year period starting after after approval of protocol by medical research committee of Sohag faculty of medicine.
|
|
Severity of tricusped regurgitation by echocardiography in pediatric patients post Fallot surgical repair.
Tidsramme: Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Data will be collected over 1 year period starting after approval of protocol by medical research committee of Sohag faculty of medicine.
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Anslået)
11. juli 2026
Primær færdiggørelse (Anslået)
15. oktober 2026
Studieafslutning (Anslået)
15. november 2026
Datoer for studieregistrering
Først indsendt
24. april 2026
Først indsendt, der opfyldte QC-kriterier
9. juli 2026
Først opslået (Faktiske)
15. juli 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
15. juli 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
9. juli 2026
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- Soh-Med--25-9-4MS
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
UBESLUTET
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ingen
Studerer et amerikansk FDA-reguleret enhedsprodukt
Ingen
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .