NCT05729490

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
17 days until next milestone

First Submitted

Initial submission to the registry

January 18, 2023

Completed
28 days until next milestone

First Posted

Study publicly available on registry

February 15, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

February 15, 2023

Status Verified

February 1, 2023

Enrollment Period

9 months

First QC Date

January 18, 2023

Last Update Submit

February 6, 2023

Conditions

Computed Tomography AngiographyCoronary Artery Disease

Outcome Measures

Primary Outcomes (3)

  • Number of techniques

    The number of possible techniques used to perform CT coronary angiography

    2 months

  • Number of pitfalls

    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

    3 months

Study Arms (1)

Participants

EXPERIMENTAL
Radiation: Coronary computed tomography angiography

Interventions

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.

Participants

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Male and female patients of at least 18 years of age, with suspected symptomatic CAD.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University hospitals

Sohag, Egypt

RECRUITING

Related Publications (4)

  • 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.

    PMID: 30157094BACKGROUND

  • 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.

    PMID: 34565701BACKGROUND

  • 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.

    PMID: 22253353BACKGROUND

  • 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.

    PMID: 19304713BACKGROUND

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary DiseaseMyocardial IschemiaHeart DiseasesCardiovascular DiseasesArteriosclerosisArterial Occlusive DiseasesVascular Diseases

Central Study Contacts

Mostafa M Gad, Resident

CONTACT

01112386670mostafa.gad.670@gmail.com

Mohammed Z Ali, Professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident of diagnostic and interventional radiology department, Sohag University Hospitals

Study Record Dates

First Submitted

January 18, 2023

First Posted

February 15, 2023

Study Start

January 1, 2023

Primary Completion

October 1, 2023

Study Completion

February 1, 2024

Last Updated

February 15, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)