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

January 11, 2017 updated by: Hiromasa Otake, Kobe University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

72

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
    • Hyogo
      • Kobe, Hyogo, Japan, 650-0017
        • Kobe University Graduate School of Medicine, Department of Cardiology

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

72 vessels in 57 patients

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
severity of calcification
All vessels were divided into tertile groups according to the severity of coronary calcification evaluated by the Agatston score.
Other: data collection, non-intervention
minimal lumen diameter (MLD) ≥1.0 mm
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.
Other: data collection, non-intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlation between cCTA and OCT for MLA measurements
Time Frame: Immediately after OCT scan
Immediately after OCT scan

Secondary Outcome Measures

Outcome Measure
Time Frame
Correlation between FFRCT and FFROCT
Time Frame: Immediately after OCT scan
Immediately after OCT scan
Impact of calcification on the agreement of MLA between OCT and cCTA measurement
Time Frame: Immediately after OCT scan
Immediately after OCT scan
Impact of calcification on the agreement of FFR between OCT and cCTA
Time Frame: Immediately after OCT scan
Immediately after OCT scan

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kobe University

Collaborators

HeartFlow, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2016

Primary Completion (Actual)

August 1, 2016

Study Completion (Actual)

August 1, 2016

Study Registration Dates

First Submitted

January 10, 2017

First Submitted That Met QC Criteria

January 11, 2017

First Posted (Estimate)

January 13, 2017

Study Record Updates

Last Update Posted (Estimate)

January 13, 2017

Last Update Submitted That Met QC Criteria

January 11, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • No.160040

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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