NCT06752187

Brief Summary

Congenital heart disease (CHD) is the most prevalent congenital anomaly and a major cause of infant morbidity and mortality. It encompasses various cardiac chamber anomalies. CHD diagnosis relied on clinical information from auscultation and heart sounds, with X-rays providing indirect information. Since the 1970s, echocardiography has become the primary diagnostic tool due to its direct, safe, and portable nature, capable of defining anatomy and estimating hemodynamics. However, echocardiography has limitations, While CT provides valuable anatomical details, it lacks hemodynamic information and involves ionizing radiation. MRI, on the other hand, excels in both anatomical and functional analysis, offering detailed hemodynamic evaluations of blood flow through valves, great vessels, and septal defects.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
55

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2025

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 21, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 30, 2024

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2025

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

December 30, 2024

Status Verified

December 1, 2024

Enrollment Period

1 year

First QC Date

December 21, 2024

Last Update Submit

December 21, 2024

Conditions

Keywords

Congenital heart diseaseMRI

Outcome Measures

Primary Outcomes (1)

  • Evaluation of hemodynamics in congenital heart disease

    • The added value of MRI is evaluation of cardiac hemodynamics in congenital heart disease, and these hemodynamics include evaluation of the direction \& amount of blood flow through valves ,great vessels and septal defects.

    Baseline

Eligibility Criteria

Age0 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The study population will include infants and children aged 0-18 years who are either suspected of having or diagnosed with congenital heart disease (CHD). Inclusion will require patients referred for magnetic resonance imaging (MRI) to further evaluate cardiac anatomy, function, or associated vascular anomalies.

You may qualify if:

  • Infants and children who diagnosed or suspected congenital heart diseases
  • Infants and children who can tolerate sedation or general anesthesia

You may not qualify if:

  • patients with contraindications to MRI as pacemaker or defibrillator
  • patients unable to tolerate sedation or anesthesia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Muntean I, Toganel R, Benedek T. Genetics of Congenital Heart Disease: Past and Present. Biochem Genet. 2017 Apr;55(2):105-123. doi: 10.1007/s10528-016-9780-7. Epub 2016 Nov 2.

    PMID: 27807680BACKGROUND
  • Fratz S, Chung T, Greil GF, Samyn MM, Taylor AM, Valsangiacomo Buechel ER, Yoo SJ, Powell AJ. Guidelines and protocols for cardiovascular magnetic resonance in children and adults with congenital heart disease: SCMR expert consensus group on congenital heart disease. J Cardiovasc Magn Reson. 2013 Jun 13;15(1):51. doi: 10.1186/1532-429X-15-51.

    PMID: 23763839BACKGROUND
  • Renz DM, Bottcher J, Eckstein J, Huisinga C, Pfeil A, Lucke C, Gutberlet M. [Imaging of congenital heart defects with a focus on magnetic resonance imaging and computed tomography]. Radiologie (Heidelb). 2024 May;64(5):382-391. doi: 10.1007/s00117-024-01301-4. Epub 2024 Apr 24. German.

    PMID: 38656344BACKGROUND
  • Ma P, Zhu L, Wen R, Lv F, Li Y, Li X, Zhang Z. Revolutionizing vascular imaging: trends and future directions of 4D flow MRI based on a 20-year bibliometric analysis. Quant Imaging Med Surg. 2024 Feb 1;14(2):1873-1890. doi: 10.21037/qims-23-1227. Epub 2024 Jan 18.

    PMID: 38415143BACKGROUND

MeSH Terms

Conditions

Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Cardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

December 21, 2024

First Posted

December 30, 2024

Study Start

January 1, 2025

Primary Completion

January 1, 2026

Study Completion

February 1, 2026

Last Updated

December 30, 2024

Record last verified: 2024-12