N/A
N=175
Focused Field of View Calcium Scoring Prior to Coronary CT Angiography
Radiation Safety · Coronary Computed Tomography Angiography · Coronary Artery Disease
Bottom Line
View on ClinicalTrials.gov: NCT02972242 ↗Enrolled (actual)
175
Serious AEs
0.0%
Results posted
Jun 2020
Primary outcome: Primary: Qualitative Quality Comparison — 4; 4 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Field of View (Radiation)
- Age
- Adult, Older Adult · 50+ yrs
- Sex
- All
- Sponsor
- Walter Reed National Military Medical Center
- Primary completion
- Mar 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Qualitative Quality Comparison |
4; 4 | — |
| PRIMARY Quantitative Quality Comparison |
16.8; 17.9 | — |
| SECONDARY Number of Patients With Coronary CT Parameter Changes (mA by 50). |
35; 49 | — |
| SECONDARY Number of Patients With Coronary CT Parameter Changes (Tube Potential). |
23; 22 | — |
| SECONDARY Number of Patients With Coronary CT Using High Definition Scanning. |
7; 10 | — |
| SECONDARY Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds). |
16; 15 | — |
| SECONDARY Comparison Radiation Exposure in Non-Con CT (Dose Length Product) |
10; 53 | — |
| SECONDARY Comparison Radiation Exposure Contrast Coronary CT (Dose Length Product / Milli-sieverts) |
240; 295 | — |
| SECONDARY Number of Participants for Which There Was a Scan Termination Event |
0; 0 | — |
Summary
Coronary computed tomography angiography (CCTA) is a frequently performed test for the diagnosis and/or exclusion of coronary artery disease (CAD) in appropriately selected patients. The performance of non-contrast computed tomography for the detection and quantification of coronary calcification is typically performed prior to CCTA in an effort to identify significant calcification which may influence subsequent data acquisition during the CCTA. However, performance of calcium scoring adds significant radiation and most coronary calcification is proximal in its location, potentially visualized using a focused non-contrast scan.
The purpose of this study is to prospectively compare the usefulness of a modified non-contrast CT, using a significantly shorter scan length and lower radiation parameters, as compared to standard coronary artery calcium scanning for the detection of coronary calcification that may influence subsequent CCTA performance.
Eligibility Criteria
Inclusion Criteria
- Consenting adult patients ≥ 50 years of age;
- Suspected but without known prior history of CAD. Prior CAD is defined as a history of myocardial infarction, coronary revascularization or ≥ 50% coronary lumen stenosis on prior coronary angiography
- Scheduled for non-emergent clinically indicated coronary CT angiography
Exclusion Criteria
- Prior coronary bypass graft (CABG) surgery
- Suspicion of acute coronary syndrome (MI or unstable angina)
- Known complex congenital heart disease
- Evidence of ongoing or active clinical instability, including chest pain (sudden onset); cardiogenic shock; unstable blood pressure with systolic blood pressure 1.5 mg/dL)
- Concomitant participation in another clinical trial in which patient is subject to investigation drug or device
- Pregnancy or unknown pregnancy status
- Allergy to iodinated contrast agent
- Contraindications to nitroglycerin
- Unwilling or unable to give consent
- Inability to comply with study procedures
- Prior coronary artery calcium score and/or coronary CT angiogram
Data sourced from ClinicalTrials.gov (NCT02972242). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.