Congenital Heart DiseaseNCT06749548
A Comparison of Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases
An observational study of Congenital Heart Disease, run by Superior University at 1 site in Pakistan.
Trial summary
Multi-detector computed tomography angiography (MDCTA) provides high-resolution images of the heart and its vasculature, allowing for accurate anatomical assessment, detection of complex cardiac morphology, Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Congenital Heart Disease
- What is being tested?
- Group 1
- Type of treatment
- Surgery or procedure
- How many people
- 122 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Mar 2024to 2 Mar 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: the Aim is to compare the Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases
Who may be able to join
- age above 18 and less than 65.
- having Congenital Cyanotic Heart Diseases
Who cannot join
- heart surgery
- other heart issues
- not consented
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Timergara Teaching Hospital, Timergara District Dir Lower
Peshawar, Khyber Pakhtunkhwa
About this study
Official title: A Comparison of Multidetector Computed Tomography and Transthoracic Echocardiography in the Diagnosis of Congenital Cyanotic Heart Diseases
Multi-detector computed tomography angiography (MDCTA) provides high-resolution images of the heart and its vasculature, allowing for accurate anatomical assessment, detection of complex cardiac morphology,
Read the detailed description
evaluation of coronary artery anatomy, and identification of extracardiac anomalies including the coronaries, pulmonary arteries, aorta, and pulmonary or systemic veins, and it delineates vessel walls and also displays the airway, mediastinal abnormalities, and pulmonary parenchyma by using contrast media. This modality is particularly useful for evaluating complex cardiac anatomy and identifying potential surgical or interventional targets.
- Conditions
- Congenital Heart Disease
- Being tested
- Group 1
- Medical subject headings
- Heart Defects, Congenital
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group 1Radiation
the study is to emphasize the role of Computed Tomography Angiography (MDCTA) and Transthoracic Echocardiography (Echo) in the diagnosis of congenital cyanotic heart diseases.
What is being measured
The primary outcome is the main question the study is designed to answer.
Computed Tomgraphy Angiogrpahy
All patients will undergo MDCT using a 128-slice scanner. A contrast agent will be administered to visualize the heart's vascular structures. Detailed images of the heart's chambers, major blood vessels, and defects will be acquired
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Dec 2024
- Study start1 Mar 2024
- Primary completion1 Sep 2024
- Study completion2 Mar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Congenital Heart DiseaseStudies of the same condition, open and under way.
- More trials run by Superior 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-control
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Superior University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Muhammad Naveed Babur, Superior University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06749548
- Sponsor's protocol ID
- MSAHS/Batch-Spring23/042
- Status last verified
- Dec 2024
- First submitted
- 19 Dec 2024
- Last updated
- 27 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Multidetector Computed Tomography and Transthoracic Echocardiography in the Diagnosis of Congenital Cyanotic Heart Diseases
- ClinicalTrials.gov ID
- NCT06749548
- Acronym / sponsor ID
- MSAHS/Batch-Spring23/042
- Conditions
- Congenital Heart Disease
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Superior UniversityUniversity, hospital or other
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Sep 2024 (actual)
- Study completion
- 2 Mar 2025 (estimated)
- First posted
- 27 Dec 2024 (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.
Multi-detector computed tomography angiography (MDCTA) provides high-resolution images of the heart and its vasculature, allowing for accurate anatomical assessment, detection of complex cardiac morphology,
Detailed description
evaluation of coronary artery anatomy, and identification of extracardiac anomalies including the coronaries, pulmonary arteries, aorta, and pulmonary or systemic veins, and it delineates vessel walls and also displays the airway, mediastinal abnormalities, and pulmonary parenchyma by using contrast media. This modality is particularly useful for evaluating complex cardiac anatomy and identifying potential surgical or interventional targets.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- the Aim is to compare the Multidetector CT and TE in the Diagnosis of Congenital Cyanotic Heart Diseases
Key inclusion criteria (2 listed)
- age above 18 and less than 65.
- having Congenital Cyanotic Heart Diseases
Key exclusion criteria (3 listed)
- heart surgery
- other heart issues
- not consented
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 |
|---|---|---|
| Group 1the study is to emphasize the role of Computed Tomography Angiography (MDCTA) and Transthoracic Echocardiography (Echo) in the diagnosis of congenital cyanotic heart diseases. | Radiation | – |
Primary outcome
Computed Tomgraphy Angiogrpahy
Time frame: 12 Months
All patients will undergo MDCT using a 128-slice scanner. A contrast agent will be administered to visualize the heart's vascular structures. Detailed images of the heart's chambers, major blood vessels, and defects will be acquired
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Congenital Heart Disease, run by Superior University at 1 site in Pakistan.
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 2 inclusion and 3 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: under way, not looking for participants, as of the sponsor's last update on 27 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Pakistan. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Computed Tomgraphy Angiogrpahy (time frame: 12 Months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 Dec 2024.