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

Coronary Artery Disease Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021382
• Other study ID #: No.160040
• Status: Completed
• Phase: N/A
• First received: January 10, 2017
• Last updated: January 11, 2017
• Start date: July 2016
• Est. completion date: August 2016

Study information

• Verified date: January 2017
• Source: Kobe University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 72
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 90 Years

Eligibility

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

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia

Intervention

Other:
• data collection, non-intervention

Locations

Country	Name	City	State
Japan	Kobe University Graduate School of Medicine, Department of Cardiology	Kobe	Hyogo

Sponsors (2)

Lead Sponsor	Collaborator
Kobe University	HeartFlow, Inc.

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between cCTA and OCT for MLA measurements		Immediately after OCT scan	No
Secondary	Correlation between FFRCT and FFROCT		Immediately after OCT scan	No
Secondary	Impact of calcification on the agreement of MLA between OCT and cCTA measurement		Immediately after OCT scan	No
Secondary	Impact of calcification on the agreement of FFR between OCT and cCTA		Immediately after OCT scan	No