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

NCT ID: NCT03021382

Last Updated: 2017-01-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

72 participants

Study Classification

OBSERVATIONAL

Study Start Date

2016-07-31

Study Completion Date

2016-08-31

Brief Summary

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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

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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.

Conditions

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Coronary Artery Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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severity of calcification

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

data collection, non-intervention

Intervention Type OTHER

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.

data collection, non-intervention

Intervention Type OTHER

Interventions

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data collection, non-intervention

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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HeartFlow, Inc.

INDUSTRY

Sponsor Role collaborator

Kobe University

INDUSTRY

Sponsor Role lead

Responsible Party

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Hiromasa Otake

Department of Internal Medicine, Kobe University Graduate School of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, Japan

Site Status

Countries

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Japan

Other Identifiers

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No.160040

Identifier Type: -

Identifier Source: org_study_id

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