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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03021382

Enrollment

Registered

2017-01-13

Start date

2016-07-31

Completion date

2016-08-31

Last updated

2017-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Coronary Artery Disease

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.

Interventions

OTHERdata collection, non-intervention

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 90 Years

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

Design outcomes

Primary

Measure	Time frame
Correlation between cCTA and OCT for MLA measurements	Immediately after OCT scan

Secondary

Measure	Time frame
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

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026