Comparisons of Morphological Measurement Between Coronary... | NCT03021382

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

NCT03021382

Sponsor

Kobe University

Status

Completed

Last Update Posted

Jan 13, 2017Estimated

Enrollment

72Actual

Phase

Not provided

Conditions

Coronary Artery Disease

Interventions

data collection, non-intervention

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2016

Primary Completion Date

Aug 2016Actual

Completion Date

Aug 2016Actual

First Submitted Date

Jan 10, 2017

First Submission Date that Met QC Criteria

Jan 11, 2017

First Posted Date

Jan 13, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 11, 2017

Last Update Posted Date

Jan 13, 2017Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Hiromasa Otake, Department of Internal Medicine, Kobe University Graduate School of Medicine, Kobe UniversityPrincipal Investigator

Lead Sponsor

Kobe UniversityINDUSTRY

Collaborators

Name	Class
HeartFlow, Inc.	INDUSTRY

Description Module

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.

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

72Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
data collection, non-intervention	Other		minimal lumen diameter (MLD) ≥1.0 mm severity of calcification

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

72 vessels in 57 patients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kobe University Graduate School of Medicine, Department of Cardiology		Kobe	Hyōgo	650-0017	Japan

Condition Browse Module

MeSH Terms

ID	Term
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003625	Data Collection

Ancestor Terms

ID	Term
D004812	Epidemiologic Methods
D008919	Investigative Techniques
D017531	Health Care Evaluation Mechanisms
D011787	Quality of Health Care

Browse Leaves

Not provided

Browse Branches

Not provided