MSCT in Congenital Cardiovascular DiseaseNCT04787172
Role of the MSCT in Evaluation of the Congenital Cardiovascular Anomalies
An observational study of MSCT in Congenital Cardiovascular Disease, run by Assiut University.
Trial 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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- MSCT in Congenital Cardiovascular Disease
- What is being tested?
- Multi Slice computed tomography
- Type of treatment
- Surgery or procedure
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2021to 1 Sep 2022
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All patients attending to the cardiovascular departement and diagnosed as congenital cardiovascular anomalies
Who may be able to join
- patients suffering from congenital cardiovascular diseases diagnosed either clinically or by echocardiographic examination.
Who cannot join
- orthopenic patient patients with hypersensitivity to contrast , medium and poor renal function .
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Role of the Multi-Slice Computed Tomography in Evaluation of the Congenital Cardiovascular Anomalies
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 .
Read the detailed description
The interpretation of cardiovascular structures on cardiac CT scan studies is similar to that for echocardiography, however, it is not limited by the acoustic window or operator dependent like ultrasonography. In addition to the anatomic information, a cardiac CT scan provides hemodynamic information, including extracardiac and intra-cardiac shunts. It also enables the systematic evaluation of other thoracic structures like cardiovascular structures, the airways and the lungs by using maximum and minimum intensity projections to delineate the vascular and airway structures, respectively. Extra-cardiac great vessels can be evaluated along their length; thus augmenting the role of cardiac CT scans in children with congenital heart diseases .Inspite of the poorer temporal resolution of cardiac CTA compared to echocardiography, yet the combination of rapid acquisition time, increased anatomic coverage, high spatial resolution, multiplanar reformation and 3D capability combined with a flexible ECG synchronization have improved the image quality of cardiac CT scans and minimizing the patient risks. Multidetector computed tomography has greatly advanced the noninvasive diagnosis of these anomalies in pediatric patient, thus makes MDCT an ideal non- invasive method for evaluating pediatric patients .
- Being tested
- Multi Slice computed tomography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Multi Slice computed tomographyRadiation
use of MSCT as a diagnostic tool in evaluation of patients with congenital cardiovascular anomalies
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jun 2021 (estimated)
- Primary completion1 Jun 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for MSCT in Congenital Cardiovascular DiseaseStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sara Ali Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04787172
- Sponsor's protocol ID
- MSCT in congenital CVA
- Status last verified
- Mar 2021
- First submitted
- 4 Mar 2021
- Last updated
- 8 Mar 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 24761701
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Role of the Multi-Slice Computed Tomography in Evaluation of the Congenital Cardiovascular Anomalies
- ClinicalTrials.gov ID
- NCT04787172
- Acronym / sponsor ID
- MSCT in congenital CVA
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2021 (estimated)
- Primary completion
- 1 Jun 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 8 Mar 2021 (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.
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 .
Detailed description
The interpretation of cardiovascular structures on cardiac CT scan studies is similar to that for echocardiography, however, it is not limited by the acoustic window or operator dependent like ultrasonography. In addition to the anatomic information, a cardiac CT scan provides hemodynamic information, including extracardiac and intra-cardiac shunts. It also enables the systematic evaluation of other thoracic structures like cardiovascular structures, the airways and the lungs by using maximum and minimum intensity projections to delineate the vascular and airway structures, respectively. Extra-cardiac great vessels can be evaluated along their length; thus augmenting the role of cardiac CT scans in children with congenital heart diseases .Inspite of the poorer temporal resolution of cardiac CTA compared to echocardiography, yet the combination of rapid acquisition time, increased anatomic coverage, high spatial resolution, multiplanar reformation and 3D capability combined with a flexible ECG synchronization have improved the image quality of cardiac CT scans and minimizing the patient risks. Multidetector computed tomography has greatly advanced the noninvasive diagnosis of these anomalies in pediatric patient, thus makes MDCT an ideal non- invasive method for evaluating pediatric patients .
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All patients attending to the cardiovascular departement and diagnosed as congenital cardiovascular anomalies
Key inclusion criteria (1 listed)
- patients suffering from congenital cardiovascular diseases diagnosed either clinically or by echocardiographic examination.
Key exclusion criteria (1 listed)
- orthopenic patient patients with hypersensitivity to contrast , medium and poor renal function .
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Multi Slice computed tomographyuse of MSCT as a diagnostic tool in evaluation of patients with congenital cardiovascular anomalies | Radiation | – |
Primary outcome
accuracy of the MSCT in congenital cardiovascular anomalies
Time frame: baseline
comparison between sensitivity and accuracy of MSCT in detection of congenital cardiovascular anomalies with detection rate by cardiac catheterization or surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2021.
- Results publication: PubMed 24761701Goitein 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.
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.
Questions about this trial
What is this clinical trial studying?
An observational study of MSCT in Congenital Cardiovascular Disease, 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 8 Mar 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 Sara Ali Gamal, MD (01020230930, sararad423@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
accuracy of the MSCT in congenital cardiovascular anomalies (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 NCT04787172, which also lists 1 linked publication.
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 8 Mar 2021.