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

NCT03021382 | Completed

• 1 other identifier: No.160040
• Study Type: observational
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Coronary Artery Disease

Outcome Measures

Primary Outcomes (1)

• Correlation between cCTA and OCT for MLA measurements

  Immediately after OCT scan

Secondary Outcomes (3)

• Correlation between FFRCT and FFROCT

  Immediately after OCT scan

• Impact of calcification on the agreement of MLA between OCT and cCTA measurement

  Immediately after OCT scan

• Impact of calcification on the agreement of FFR between OCT and cCTA

  Immediately after OCT scan

Study Arms (2)

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

Interventions

data collection, non-intervention OTHER

minimal lumen diameter (MLD) ≥1.0 mm; severity of calcification

Eligibility Criteria

• Age: 20 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

72 vessels in 57 patients

You may qualify if:

• \- Patients who underwent cCTA prior to coronary angiography and OCT within 6 months.

You may not qualify if:

• Prior coronary artery bypass graft (CABG) surgery
• Contraindication to beta blocker agents or nitrates
• Tachycardia or significant arrhythmia
• Impaired chronic renal function (eGFR \<30)
• Subjects with known anaphylactic allergy to iodinated contrast material
• Pregnancy or unknown pregnancy status in subject of childbearing potential
• Cases with poor OCT or CCTA image for analyzing

Sponsors & Collaborators

• Kobe University: lead
• HeartFlow, Inc.: collaborator

Study Sites (1)

Kobe University Graduate School of Medicine, Department of Cardiology

Kobe, Hyōgo, 650-0017, Japan

Location

MeSH Terms

Conditions

Coronary Artery Disease

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department of Internal Medicine, Kobe University Graduate School of Medicine

Study Record Dates

• First Submitted: January 10, 2017
• First Posted: January 13, 2017
• Study Start: July 1, 2016
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: January 13, 2017

Record last verified: 2017-01

Locations

JP (1)