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

Kobe University

Status: Completed

Conditions: Coronary Artery Disease

Treatments: Other: data collection, non-intervention

Study type: Observational

Funder types: Industry

Identifiers

NCT03021382

No.160040

Details and patient eligibility

About

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.

Full 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.

Enrollment: 72 patients

Sex: All

Ages: 20 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

72 participants in 2 patient groups

severity of calcification

Description:

All vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score.

Treatment:

Other: data collection, non-intervention

minimal lumen diameter (MLD) ≥1.0 mm

Description:

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.

Treatment:

Other: data collection, non-intervention