Focused Field of View Calcium Scoring Prior to Coronary CT Angiography (FOCUS-CCTA)
Radiation Safety, Coronary Computed Tomography Angiography, Coronary Artery Disease
About this trial
This is an interventional diagnostic trial for Radiation Safety
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 < 90 mmHg; and severe congestive heart failure (NYHA class III or IV); or acute pulmonary embolism
- Atrial fibrillation
- Abnormal renal function (GFR < 60 ml/min; Creatinine > 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Active Comparator
Placebo Comparator
Modified Field of View
Standard Field of View
In patients randomized to undergo the modified non-contrast CT scan to assess coronary calcification burden, this study will be performed by a radiologist and cardiologist as follows: axial acquisition obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage 80kV and tube current 250mA. The scan length will be from 1 cm below the carina to the level beneath the proximal coronary vessels defined as the greatest diameter of the apex of the right atrium.
In patients randomized to standard coronary artery calcium scoring, this scan will be performed in usual axial fashion obtained at 70% of the R-R interval using the following parameters: rotation time 0.35 sec; collimation of 64 x 0.625mm; detector coverage of 20.0 mm; axial thickness 2.5; tube voltage, 120 kV and tube current 250mA. The scan length, in accordance with current protocol, will be from 1 cm below the carina through the diaphragms.