- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT07655843
Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder
Cardiovascular Abnormalities in Children With Attention-deficit/Hyperactivity Disorder Attending Assiut University Children Hospital: A Case Control Study
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
Introduction
ADHD is a common and highly heritable neurodevelopmental disorder with an estimated worldwide prevalence of 3-7% in childhood and adolescence, and around 3% in adulthood . The prevalence of ADHD in the Middle East and North Africa region is estimated at approximately 10.3% among children, adolescents, and adults. The estimated prevalence was 12% in Egypt .
ADHD is characterized by developmentally inappropriate, pervasive and impairing inattention and/or hyperactivity-impulsivity. In addition to the core clinical symptoms of ADHD, co-occurring poor mental and physical comorbidities are prevalent in individuals with ADHD. However, compared with the extensive research of psychiatric comorbidities in ADHD, physical comorbidities, such as cardiovascular diseases , have received less attention, particularly among adults .
ADHD has a multifactorial etiology; however, its prevalence appears significantly higher in children with congestive heart disease, particularly those undergoing complex cardiac procedures such as aortic arch repair or correction of transposition of the great arteries . Children and adolescents with ADHD have a higher risk for cardiovascular disease. Common carotid intima media thickness , epicardial adipose tissue thickness , and periaortic adipose tissue thickness were higher in children and adolescents with ADHD, and therefore they were at risk for CVD .
A recent genetic study revealed weak-to-moderate genetic correlations of ADHD with BMI, coronary artery disease and levels of triglycerides and HDL cholesterol.
There are several reasons why individuals with ADHD could be at increased risk for CVDs. First, previous research suggests that the link between ADHD and CVDs is biologically plausible via immune system abnormalities, neuromodulator dysregulation, and dysregulation of the hypothalamic-pituitary-adrenal axis . Second, individuals with ADHD are at increased risk for unhealthy lifestyle factors (e.g., obesity, poor physical activity) which are all well-established risk factors for CVDs . Third, previous studies indicate that several psychiatric comorbidities of ADHD, for example, depression, substance use disorders, bipolar disorder, are associated with CVDs . Fourth, even though findings are inconclusive, there has been a long-standing concern around a potential increased risk of cardiovascular events due to the use of stimulant medications to treat ADHD. Most ADHD treatments are known to elevate heart rate and blood pressure through stimulation of the sympathetic nervous system, thus potentially conferring a risk of cardiovascular side-effects. Acute coronary syndromes, stroke, and heart failure have all been linked with treatment in some reports. However, the available epidemiological findings are mixed, despite the potential hypotheses for an increased risk of CVDs in ADHD.
Undersøgelsestype
Tilmelding (Anslået)
Kontakter og lokationer
Studiekontakt
- Navn: Ahmed A Ahmed Allam, MBBCH
- Telefonnummer: 01063146513
- E-mail: Ahmed.16266349@med.aun.edu.eg
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Barn
- Voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Participants will be divided into:
- A case group: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment.
- A control group: composed of age and sex matched neurotypical children.
Beskrivelse
Inclusion Criteria:
Case group :
- Age is > 6 years and <18 years old
- Both sex
- Patients diagnosed as having ADHD according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria.
- Currently receiving pharmacological treatment for at least six months
Control group:
Healthy, typically developing children , matched by age and sex to the case group
-
Exclusion Criteria:
- Age > 18 years
- Patients who have a history of chronic diseases.
- Patients with established hereditary syndromes or chromosomal abnormalities as Down syndrome.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
|---|---|
|
case group
: consisting of pediatric patients previously diagnosed with ADHD according to DSM/5 criteria currently receiving pharmacological treatment.
|
|
|
control group
composed of age and sex matched neurotypical children
|
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
prevalence of ECG and echocardiographic abnormalities in children with ADHD.
Tidsramme: within one week of emrollment
|
The percentage of children diagnosed with Attention-Deficit/Hyperactivity Disorder (ADHD) who exhibit one or more predefined structural or functional cardiac abnormalities on electrocardiogram (ECG) or transthoracic echocardiography (Echo). Abnormalities will be defined as: ECG Abnormalities: Prolonged corrected QT interval (QTc > 450\text{ ms} for males, > 460\text{ ms} for females using Bazett's formula), pathologic T-wave inversions, conduction blocks (e.g., right bundle branch block), or arrhythmias (e.g., ventricular premature beats). Echocardiographic Abnormalities: Left ventricular hypertrophy, structural congenital heart defects, valvular regurgitation (mitral/tricuspid) graded as moderate or severe, or reduced systolic function (Left Ventricular Ejection Fraction < 55\%). All assessments will be performed by a single blinded investigator using standard pediatric clinical guidelines to ensure consistency |
within one week of emrollment
|
|
systolic blood pressure
Tidsramme: within one week of enrollment
|
Comparison of systolic blood pressure (measured via a standard automated pediatric sphygmomanometer) across the study groups. Unit of Measure: Millimeters of mercury (mmHg) |
within one week of enrollment
|
|
diastolic blood pressure
Tidsramme: within one week of enrollment
|
Comparison of systolic blood pressure (measured via a standard automated pediatric sphygmomanometer) across the study groups. Unit of Measure: Millimeters of mercury (mmHg) |
within one week of enrollment
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
body mass index
Tidsramme: within one week of enrollment
|
Anthropometric measurement to correlate nutritional/growth status with cardiac findings across the cohorts. Unit of Measure: Z-score (standard deviations from the mean based on WHO growth charts) |
within one week of enrollment
|
Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Anslået)
Primær færdiggørelse (Anslået)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Hjerte-kar-sygdomme
- Medfødte abnormiteter
- Medfødte, arvelige og neonatale sygdomme og abnormiteter
- Kardiovaskulære abnormiteter
- Diagnostiske teknikker og procedurer
- Diagnose
- Diagnostisk billeddannelse
- Diagnostiske teknikker, kardiovaskulær
- Hjertefunktionstest
- Elektrodiagnose
- Hjertebillede -teknikker
- Ultrasonografi
- Elektrokardiografi
- Ekkokardiografi
Andre undersøgelses-id-numre
- ADHD
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .
Kliniske forsøg med ADHD - kombineret type
-
Wuhan Sports UniversityAfsluttetADHD | ADHD - kombineret type | ADHD - uopmærksom type | ADHD - Attention Deficit Disorder med hyperaktivitet | ADHD specifikt med nedsat eksekutiv funktionKina
-
St. Antonius HospitalIkke rekrutterer endnuADHD | Attention Deficit Disorder med hyperaktivitet | Attention Deficit Disorder | TILFØJE | ADHD Overvejende uopmærksom type | ADHD, overvejende hyperaktiv - impulsiv | Attention Deficit Disorder (ADD) | Hyperaktivitet | Uopmærksomhed | ADHD Overvejende hyperaktivitetstype | ADHD-ikke andet specificeret | Hype... og andre forhold
-
The Hong Kong Polytechnic UniversityRekruttering
-
Loewenstein HospitalWingate InstituteRekruttering
-
Region Örebro CountyAktiv, ikke rekrutterende
-
University of TorontoAfsluttet
-
Massachusetts General HospitalCenter for Survey Research, University of Massachusetts, BostonAfsluttet
-
Akili Interactive Labs, Inc.Aktiv, ikke rekrutterende
-
L'hôpital Nord-Ouest - Villefranche Villefranche...Afsluttet
-
Johns Hopkins UniversityTrukket tilbage
Kliniske forsøg med echocardiography and ECG
-
CHA UniversityRekrutteringMyokardieinfarkt (MI) | Brystsmerter udelukker myokardieinfarktSydkorea
-
Ain Shams UniversityAfsluttetDødelighed | Septisk chok | Intensivafdeling | Venstre ventrikulær ejektionsfraktion | HyperdynamiskEgypten
-
National Defense Medical Center, TaiwanRekrutteringHypertension, lunge | Kunstig intelligens (AI) | Kunstig intelligens (AI) i diagnoseTaiwan
-
Tri-Service General HospitalIkke rekrutterer endnu
-
Charite University, Berlin, GermanyMedical University of ViennaRekrutteringHjertefejl | ICUAWØstrig, Tyskland
-
Heinrich-Heine University, DuesseldorfRekrutteringAortaklapstenose | Aortaklapsygdom | Transkateter udskiftning af aortaklap | Protesens holdbarhed | Transkateter aortaklapimplantation | Symmetri | Kommissural tilpasning | Kommissural forkert justering | Prothesis positioneringTyskland
-
Shenyang Medical CollegeThe Second Hospital of Shenyang Medical CollegeRekrutteringAngstlidelser | Koronar hjertesygdom (CHD)Kina
-
Universitair Ziekenhuis BrusselRekrutteringBrystsmerter | Akutte koronare syndromer (ACS)Belgien