Comparisons of Morphological Measurement Between Coronary Computed Tomography and Optical Coherence Tomography
NCT ID: NCT03021382
Last Updated: 2017-01-13
Study Results
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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COMPLETED
72 participants
OBSERVATIONAL
2016-07-31
2016-08-31
Brief Summary
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Detailed Description
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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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Study Design
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COHORT
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
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
Interventions
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data collection, non-intervention
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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
20 Years
90 Years
ALL
No
Sponsors
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HeartFlow, Inc.
INDUSTRY
Kobe University
INDUSTRY
Responsible Party
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Hiromasa Otake
Department of Internal Medicine, Kobe University Graduate School of Medicine
Locations
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Kobe University Graduate School of Medicine, Department of Cardiology
Kobe, Hyōgo, Japan
Countries
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Other Identifiers
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No.160040
Identifier Type: -
Identifier Source: org_study_id
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