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

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT03021382
• Date of registration: 10/01/2017
• Prospective Registration: No
• Primary sponsor: Kobe University
• Public title: Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
• Date of first enrolment: July 2016
• Target sample size: 72
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT03021382
• Study type: Observational
• Phase: N/A

Countries of recruitment

Japan

Key inclusion & exclusion criteria

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



Age minimum: 20 Years
Age maximum: 90 Years
Gender: All

Health Condition(s) or Problem(s) studied

Coronary Artery Disease

Intervention(s)

Other: data collection, non-intervention

Primary Outcome(s)

Correlation between cCTA and OCT for MLA measurements [Time Frame: Immediately after OCT scan]

Secondary Outcome(s)

Impact of calcification on the agreement of FFR between OCT and cCTA [Time Frame: Immediately after OCT scan]

Impact of calcification on the agreement of MLA between OCT and cCTA measurement [Time Frame: Immediately after OCT scan]

Correlation between FFRCT and FFROCT [Time Frame: Immediately after OCT scan]

Secondary ID(s)

No.160040

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

HeartFlow, Inc.