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

Completed

• Conditions: Coronary Artery Disease
• Interventions: Other: data collection, non-intervention

• Registration Number: NCT03021382
• Lead Sponsor: Kobe University

Brief 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.

Study Timeline

• Study Start: 2016-07
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2017-01
• Study First Submitted: 2017-01-10
• Study First Submitted QC: 2017-01-11
• Last Update Submitted: 2017-01-11
• Study First Posted: 2017-01-13
• Last Update Posted: 2017-01-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

• Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.

Exclusion Criteria

1. Prior coronary artery bypass graft (CABG) surgery
2. Contraindication to beta blocker agents or nitrates
3. Tachycardia or significant arrhythmia
4. Impaired chronic renal function (eGFR <30)
5. Subjects with known anaphylactic allergy to iodinated contrast material
6. Pregnancy or unknown pregnancy status in subject of childbearing potential
7. Cases with poor OCT or CCTA image for analyzing

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
severity of calcification	data collection, non-intervention	All vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score.
minimal lumen diameter (MLD) ≥1.0 mm	data collection, non-intervention	All lesions were divided according to an MLD ≥1.0 mm, and \<1.0 mm by OCT in order to isolate the lesions which an MLD below the OCT catheter size.

Primary Outcome Measures

Name	Time	Method
Correlation between cCTA and OCT for MLA measurements	Immediately after OCT scan

Secondary Outcome Measures

Name	Time	Method
Correlation between FFRCT and FFROCT	Immediately after OCT scan
Impact of calcification on the agreement of MLA between OCT and cCTA measurement	Immediately after OCT scan
Impact of calcification on the agreement of FFR between OCT and cCTA	Immediately after OCT scan

Trial Locations

Locations (1)

Kobe University Graduate School of Medicine, Department of Cardiology; 🇯🇵 Kobe, Hyogo, Japan