Focused Field of View Calcium Scoring Prior to Coronary CT Angiography

NCT02972242 | Completed Results

• 1 other identifier: 396906
• Study Type: interventional
• Target: 175
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

Radiation Safety; Coronary Computed Tomography Angiography; Coronary Artery Disease

Outcome Measures

Primary Outcomes (2)

• Qualitative Quality Comparison

  The measurement of quality in comparison of the modified versus non-modified CCTA using a qualitative (four point scale). 1. = Nondiagnostic: Impaired image quality that precluded appropriate evaluation of the coronary arteries due to severe motion artifacts, extensive blooming artifact, severe image noise, or insufficient contrast. 2. = Adequate: Reduced image quality because of artifacts due to motion, image noise or low contrast attenuation, but sufficient to rule-out significant stenosis. 3. = Good: Presence of artifacts caused by motion, image noise, coronary calcifications or low contrast, but fully preserved ability to assess the presence of luminal stenosis as well as the presence of calcified and non-calcified coronary atherosclerotic plaque. 4. = Excellent: Complete absence of motion artifacts, strong attenuation of vessel lumen and clear delineation of vessel walls, with the ability to assess stenosis and plaque characteristics.

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

• Quantitative Quality Comparison

  The measurement of quality in comparison of the modified versus non-modified CCTA using a quantitative score (CCTA signal, noise, signal to noise ratio): image signal and noise obtained during scan analysis by placing a circular region of interest (1 cm in diameter) within the proximal ascending aorta and there measuring Hounsfield Units (HU) which is the CCTA "signal" and standard deviation of the HU within that same region (which is the "noise"), the ratio of these signal/noise is also captured by this method.

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

Secondary Outcomes (7)

• Number of Patients With Coronary CT Parameter Changes (mA by 50).

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

• Number of Patients With Coronary CT Parameter Changes (Tube Potential).

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

• Number of Patients With Coronary CT Using High Definition Scanning.

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

• Number of Patients With Coronary CT Parameter Changes (Padding in Milliseconds).

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

• Comparison Radiation Exposure in Non-Con CT (Dose Length Product)

  Following completion of data acquisition (i.e. CT scans) for all patients (last patient scan was 2/26/18), each outcome measure was then assessed (this process spanned approximately 3 months from March to June 2018).

Study Arms (2)

Modified Field of View

ACTIVE COMPARATOR

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.

Radiation: Field of View

Standard Field of View

PLACEBO COMPARATOR

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.

Radiation: Field of View

Interventions

Field of View RADIATION

Non-Contrast CT Scan for coronary calcium assessment prior to CT coronary angiography

Modified Field of View; Standard Field of View

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Walter Reed National Military Medical Center: lead

Related Publications (1)

• Crimm HA, Fergestrom NM, Dye C, Philip C, Nguyen BT, Villines TC. Focused, low tube potential, coronary calcium assessment prior to coronary CT angiography: A prospective, randomized clinical trial. J Cardiovasc Comput Tomogr. 2021 May-Jun;15(3):240-245. doi: 10.1016/j.jcct.2020.08.011. Epub 2020 Aug 22.

  PMID: 32868247 DERIVED

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Limitations and Caveats

single center design and relatively small sample size.

Results Point of Contact

• Title: Hampton Crimm
• Organization: WRNMMC Cardiology

hampton.a.crimm.mil@mail.mil

301-295-4500

Study Officials

• Hampton A Crimm, MD

  WRNMMC Cardiology Department

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: November 18, 2016
• First Posted: November 23, 2016
• Study Start: November 1, 2014
• Primary Completion: March 1, 2018
• Study Completion: March 1, 2018
• Last Updated: June 22, 2020
• Results First Posted: June 22, 2020

Record last verified: 2020-06