Computed Tomography AngiographyNCT05729490
Techniques and Pitfalls of Multi-Slice CT Coronary Angiography
A study testing Coronary computed tomography angiography in people with Computed Tomography Angiography and Coronary Artery Disease, run by Sohag University at 1 site in Egypt.
Trial summary
The goal of this study is to describe the techniques for coronary multi-slice CT angiography and to illustrate the spectrum of artifacts that can simulate coronary artery stenosis and lead to non-assessable segments using 128- and 160 multi-detector row CT scanners and discuss post-processing pitfalls with each. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Computed Tomography Angiography, Coronary Artery Disease
- What is being tested?
- Coronary computed tomography angiography
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2023to Feb 2024
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients of at least 18 years of age, with suspected symptomatic CAD.
Who cannot join
- Un cooperative patients.
- Those who have allergy to iodinated contrast material or contrast-induced nephropathy,
- Elevated serum creatinine level (1.5 mg/dl) or creatinine clearance >60 ml/min.
- Atrial fibrillation.
- Aortic stenosis.
- Percutaneous coronary intervention within the past 6 months.
Show all 9Show fewer
- Intolerance to beta-blockers.
- Body mass index > 40
- Patients with Agatston calcium scores of >400
Trial locations and contacts
1 site in 1 country.
Mohammed Z Ali, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University hospitals
Sohag
Magdy M Amin, Professor
About this study
The goal of this study is to describe the techniques for coronary multi-slice CT angiography and to illustrate the spectrum of artifacts that can simulate coronary artery stenosis and lead to non-assessable segments using 128- and 160 multi-detector row CT scanners and discuss post-processing pitfalls with each. In addition, to review the normal anatomy and anatomic variants of the coronary arteries and discuss effective strategies for improving the diagnostic accuracy of coronary CT angiography.
- Being tested
- Coronary computed tomography angiography
- Medical subject headings
- Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary computed tomography angiographyRadiation
All patients will be subjected to:
Two CT scans (coronary calcium scoring and angiography) using 128 or 160-row scanners with a slice thickness of 0.5 mm (Revolution Evo 128, GE Health care, Chicago, Illinois, USA) or (Aquilion 160, Canon Medical Systems, Tochigi, Japan). Calcium scoring will be performed with the use of prospective electrocardiographic gating with 400-ms gantry rotation, 120-kV tube voltage, and 300-mA tube current. For CTA, retrospective electrocardiographic gating will be used, with heart rate adjusted gantry rotations of 350 ms to 500 ms to enable adaptive multisegmented reconstruction.
Iopromide (Ultravist 370, Bayer AG, Berlin, Germany) is the intravenous contrast medium that will be used for CTA. Beta-blockers will be given if the resting heart rate is 70 beats/min.
| Study group | Role | What they receive |
|---|---|---|
| Participants | Experimental | Not described Receives: Radiation: Coronary computed tomography angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of techniques
The number of possible techniques used to perform CT coronary angiography
Measured: 2 months
Number of pitfalls
The number of pitfalls that could mimic coronary artery stenosis and lead to non-assessable segments
Measured: 3 months
Number of possible strategies to overcome the pitfalls of the study
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Feb 2023
- Study start1 Jan 2023
- Primary completionOct 2023 (estimated)
- Study completionFeb 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Computed Tomography AngiographyStudies of the same condition, open and under way.
- More trials run by Sohag 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mostafa Magdy Mahmoud, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05729490
- Sponsor's protocol ID
- Soh-Med-23-01-11
- Status last verified
- Feb 2023
- First submitted
- 18 Jan 2023
- Last updated
- 15 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Maroules CD, Rajiah P, Bhasin M, Abbara S. Current Evidence in Cardiothoracic Imaging: Growing Evidence for Coronary Computed Tomography Angiography as a First-line Test in Stable Chest Pain. J Thorac Imaging. 2019 Jan;34(1):4-11. doi: 10.1097/RTI.0000000000000357.
PubMed 30157094Tridandapani S, Banait-Deshmane S, Aziz MU, Bhatti P, Singh SP. Coronary computed tomographic angiography: A review of the techniques, protocols, pitfalls, and radiation dose. J Med Imaging Radiat Sci. 2021 Nov;52(3S):S1-S11. doi: 10.1016/j.jmir.2021.08.014. Epub 2021 Sep 24.
PubMed 34565701Sun Z, Choo GH, Ng KH. Coronary CT angiography: current status and continuing challenges. Br J Radiol. 2012 May;85(1013):495-510. doi: 10.1259/bjr/15296170. Epub 2012 Jan 17.
PubMed 22253353Donnino R, Jacobs JE, Doshi JV, Hecht EM, Kim DC, Babb JS, Srichai MB. Dual-source versus single-source cardiac CT angiography: comparison of diagnostic image quality. AJR Am J Roentgenol. 2009 Apr;192(4):1051-6. doi: 10.2214/AJR.08.1198.
PubMed 19304713
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Techniques and Pitfalls of Multi-Slice CT Coronary Angiography
- ClinicalTrials.gov ID
- NCT05729490
- Acronym / sponsor ID
- Soh-Med-23-01-11
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- Oct 2023 (estimated)
- Study completion
- Feb 2024 (estimated)
- First posted
- 15 Feb 2023 (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.
The goal of this study is to describe the techniques for coronary multi-slice CT angiography and to illustrate the spectrum of artifacts that can simulate coronary artery stenosis and lead to non-assessable segments using 128- and 160 multi-detector row CT scanners and discuss post-processing pitfalls with each. In addition, to review the normal anatomy and anatomic variants of the coronary arteries and discuss effective strategies for improving the diagnostic accuracy of coronary CT angiography.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Participants | Experimental | Radiation: Coronary computed tomography angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Male and female patients of at least 18 years of age, with suspected symptomatic CAD.
Key exclusion criteria (9 listed)
- Un cooperative patients.
- Those who have allergy to iodinated contrast material or contrast-induced nephropathy,
- Elevated serum creatinine level (1.5 mg/dl) or creatinine clearance >60 ml/min.
- Atrial fibrillation.
- Aortic stenosis.
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 |
|---|---|---|
| Coronary computed tomography angiographyAll patients will be subjected to: Two CT scans (coronary calcium scoring and angiography) using 128 or 160-row scanners with a slice thickness of 0.5 mm (Revolution Evo 128, GE Health care, Chicago, Illinois, USA) or (Aquilion 160, Canon Medical Systems, Tochigi, Japan). Calcium scoring will be performed with the use of prospective electrocardiographic gating with 400-ms gantry rotation, 120-kV tube voltage, and 300-mA tube current. For CTA, retrospective electrocardiographic gating will be used, with heart rate adjusted gantry rotations of 350 ms to 500 ms to enable adaptive multisegmented reconstruction. Iopromide (Ultravist 370, Bayer AG, Berlin, Germany) is the intravenous contrast medium that will be used for CTA. Beta-blockers will be given if the resting heart rate is 70 beats/min. | Radiation | Participants |
Primary outcome
Number of techniques
Time frame: 2 months
The number of possible techniques used to perform CT coronary angiography
Number of pitfalls
Time frame: 3 months
The number of pitfalls that could mimic coronary artery stenosis and lead to non-assessable segments
Number of possible strategies to overcome the pitfalls of the study
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2023.
- Background: PubMed 30157094Maroules CD, Rajiah P, Bhasin M, Abbara S. Current Evidence in Cardiothoracic Imaging: Growing Evidence for Coronary Computed Tomography Angiography as a First-line Test in Stable Chest Pain. J Thorac Imaging. 2019 Jan;34(1):4-11. doi: 10.1097/RTI.0000000000000357.
- Background: PubMed 34565701Tridandapani S, Banait-Deshmane S, Aziz MU, Bhatti P, Singh SP. Coronary computed tomographic angiography: A review of the techniques, protocols, pitfalls, and radiation dose. J Med Imaging Radiat Sci. 2021 Nov;52(3S):S1-S11. doi: 10.1016/j.jmir.2021.08.014. Epub 2021 Sep 24.
- Background: PubMed 22253353Sun Z, Choo GH, Ng KH. Coronary CT angiography: current status and continuing challenges. Br J Radiol. 2012 May;85(1013):495-510. doi: 10.1259/bjr/15296170. Epub 2012 Jan 17.
- Background: PubMed 19304713Donnino R, Jacobs JE, Doshi JV, Hecht EM, Kim DC, Babb JS, Srichai MB. Dual-source versus single-source cardiac CT angiography: comparison of diagnostic image quality. AJR Am J Roentgenol. 2009 Apr;192(4):1051-6. doi: 10.2214/AJR.08.1198.
- 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.
Mohammed Z Ali, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Coronary computed tomography angiography in people with Computed Tomography Angiography and Coronary Artery Disease, run by Sohag University at 1 site in Egypt.
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 9 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 15 Feb 2023. 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 Egypt. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mostafa M Gad, Resident (01112386670, mostafa.gad.670@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of techniques (time frame: 2 months). The study lists 3 primary outcomes in all. 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 NCT05729490, which also lists 4 linked publications.
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 15 Feb 2023.