- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05729490
Techniques and Pitfalls of Multi-Slice CT Coronary Angiography
Study Overview
Status
Intervention / Treatment
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Sohag, Egypt
- Recruiting
- Sohag University Hospitals
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Male and female patients of at least 18 years of age, with suspected symptomatic CAD.
Exclusion Criteria:
- 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.
- Intolerance to beta-blockers.
- Body mass index > 40
- Patients with Agatston calcium scores of >400
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Participants
|
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. |
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Number of techniques
Time Frame: 2 months
|
The number of possible techniques used to perform CT coronary angiography
|
2 months
|
|
Number of pitfalls
Time Frame: 3 months
|
The number of pitfalls that could mimic coronary artery stenosis and lead to non-assessable segments
|
3 months
|
|
Number of possible strategies to overcome the pitfalls of the study
Time Frame: 3 months
|
3 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
General 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.
- Tridandapani 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.
- Sun 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.
- Donnino 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-23-01-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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