Evaluation of Coronary Artery Calcification Using Gated Stationary Chest Tomosynthesis

NCT03169062 | Completed Results FDA Device

• 1 other identifier: 16-1160
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to propose a new method for evaluating coronary artery calcium scores (CACS) in individuals with coronary artery disease.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Comparison of CT Derived CACS and Tomosynthesis Scores Correlation

  Linear regression and Bland-Altman analysis will be used to examine the relationship between the CT derived CACS and tomosynthesis scores to determine the correlation

  1 year

Secondary Outcomes (1)

• Mean Correlation Coefficient of Gating

  At the conclusion of all data collection, 6 months post study completion

Study Arms (1)

All patients

EXPERIMENTAL

Gated Stationary Chest Tomosynthesis

Device: Gated Stationary Chest Tomosynthesis

Interventions

Gated Stationary Chest Tomosynthesis DEVICE

The technologist will comfortably position the patient laying face up on the imaging table. EKG leads will be placed in appropriate positions to derive an EKG signal. The EKG will be used to trigger the image collection. The subject will be asked to hold his or her breath for 25-30 seconds during the scan. Total patient preparation and imaging time should not exceed 20 minutes.

All patients

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age range: ≥18 years of age
• Intermediate Framingham Risk Score of 10 to 20% risk over the next 10 years
• Previous non-contrast enhanced chest CT in a time frame that will accommodate experimental imaging (CG-SDCT) within 4 weeks. This imaging may have already been completed at the time of enrollment or may be scheduled in the future at the time of enrollment.

You may not qualify if:

• Negative urine pregnancy test in women of child-bearing potential (WCBP) within 1 week prior to s-DCT.
• Unable to provide consent
• Pregnant or lactating
• BMI \> 33 (Patient who may not fit on a 35 x 35 detector) (Images are not clear on subjects who have a greater than 33 BMI)
• Previous history of MI or thoracic surgery.
• Disability that could interfere with the scanning process, non-ambulatory or unable to hold their breath for up to 30 seconds.
• Planned procedures or therapies in between non-contrast CT scan and study Chest tomosynthesis scan, e.g., line placement in the chest region, biopsy, etc.

Sponsors & Collaborators

• University of North Carolina, Chapel Hill: lead

Study Sites (1)

University of North Carolina of Chapel hill

Chapel Hill, North Carolina, 27599-7510, United States

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Associate Director of Clinical Research Operations, Department of Radiology
• Organization: University of North Carolina at Chapel Hill

rad_research@med.unc.edu

919-966-4997

Study Officials

• Yueh Lee, M.D

  University of North Carolina of Chapel hill

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 23, 2017
• First Posted: May 30, 2017
• Study Start: June 26, 2017
• Primary Completion: April 10, 2019
• Study Completion: April 10, 2019
• Last Updated: February 11, 2020
• Results First Posted: February 11, 2020

Record last verified: 2020-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)