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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05729490
Other study ID # Soh-Med-23-01-11
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date January 1, 2023
Est. completion date February 2024

Study information

Verified date February 2023
Source Sohag University
Contact Mostafa M Gad, Resident
Phone 01112386670
Email mostafa.gad.670@gmail.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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. 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date February 2024
Est. primary completion date October 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Radiation:
Coronary computed tomography angiography
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.

Locations

Country Name City State
Egypt Sohag University hospitals Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Number of techniques The number of possible techniques used to perform CT coronary angiography 2 months
Primary Number of pitfalls The number of pitfalls that could mimic coronary artery stenosis and lead to non-assessable segments 3 months
Primary Number of possible strategies to overcome the pitfalls of the study 3 months
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