NCT04787172

Brief Summary

Congenital heart diseases (CHDs) are considered as the most common congenital birth defects, comprising 1% of all live births . Echocardiography remains a first-line non-invasive imaging tool for establishing the diagnosis and follow-up in most patients .This method is operator dependent and limited by an acoustic window . Traditional angiography is typically utilized as the gold standard modality for diagnosing CHD, but it is an invasive method and need general anseathsia with dose of radiation exposure .After recent developments in CT and MR technologies, cardiac catheterization is no longer necessary for diagnosis .

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
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2021

Status
unknown

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

March 4, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 8, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

June 1, 2021

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2022

Completed
Last Updated

March 8, 2021

Status Verified

March 1, 2021

Enrollment Period

1 year

First QC Date

March 4, 2021

Last Update Submit

March 4, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • accuracy of the MSCT in congenital cardiovascular anomalies

    comparison between sensitivity and accuracy of MSCT in detection of congenital cardiovascular anomalies with detection rate by cardiac catheterization or surgery

    baseline

Interventions

use of MSCT as a diagnostic tool in evaluation of patients with congenital cardiovascular anomalies

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients attending to the cardiovascular departement and diagnosed as congenital cardiovascular anomalies

You may qualify if:

  • patients suffering from congenital cardiovascular diseases diagnosed either clinically or by echocardiographic examination.

You may not qualify if:

  • orthopenic patient patients with hypersensitivity to contrast , medium and poor renal function .

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Goitein O, Salem Y, Jacobson J, Goitein D, Mishali D, Hamdan A, Kuperstein R, Di Segni E, Konen E. The role of cardiac computed tomography in infants with congenital heart disease. Isr Med Assoc J. 2014 Mar;16(3):147-52.

Central Study Contacts

Sara Ali Gamal, MD

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
specialist

Study Record Dates

First Submitted

March 4, 2021

First Posted

March 8, 2021

Study Start

June 1, 2021

Primary Completion

June 1, 2022

Study Completion

September 1, 2022

Last Updated

March 8, 2021

Record last verified: 2021-03