NCT03021382

Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 72 (actual)
• Sponsor: Kobe University · Industry
• Sex: All
• Age: 20 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The objective of this study is to evaluate the precision of semi-automated lumen boundary identification from coronary computed tomography angiography (cCTA) by current version of HeartFlow software and the impact on fractional flow reserve (FFRCT) by using optical coherence tomography (OCT) as reference standard.

Detailed description

Analysis of cCTA and OCT was conducted under blind in independent organizations. After unblinding the cCTA and OCT case identification number, the OCT image was co-registered to cCTA data. After co-registration of cCTA and OCT lesion locations, the minimal lumen area (MLA) was detected with both modalities. FFROCT was calculated using OCT-updated models in which cCTA-based lumen geometry was replaced by OCT-based lumen geometry. Lesions were grouped according to their severity of calcification (using Agatston score) and minimum lumen diameter.

Conditions

• Coronary Artery Disease

Interventions

Type	Name	Description
OTHER	data collection, non-intervention

Timeline

• Start date: 2016-07-01
• Primary completion: 2016-08-01
• Completion: 2016-08-01
• First posted: 2017-01-13
• Last updated: 2017-01-13

Locations

1 site across 1 country: Japan