A Single Center Registry of Coronary OCT | NCT04855500

Studies
A Single Center Registry of Coronary OCT

NCT04855500

Sponsor

Hainan People's Hospital

Status

Unknown status

Last Update Posted

Apr 22, 2021Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Coronary Artery Disease
Optical Coherence Tomography
Registry

Interventions

Not provided

Countries

China

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

Apr 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2020Actual

Primary Completion Date

Dec 31, 2022Estimated

Completion Date

Jan 31, 2023Estimated

First Submitted Date

Apr 19, 2021

First Submission Date that Met QC Criteria

Apr 19, 2021

First Posted Date

Apr 22, 2021Actual

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

Apr 19, 2021

Last Update Posted Date

Apr 22, 2021Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Liao Wang, Deputy director of Cardiology, Hainan People's HospitalPrincipal Investigator

Lead Sponsor

Hainan People's HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This registry started January 1,2020 to collect patients who recieve coronary OCT imaging in Hainan General Hospital.All enrolled patients will receive 1 year followed-up.

Detailed Description

This registry started January 1,2020.Patients >= 18 years old who recieve coronary OCT imaging in Hainan General Hospital are included in current registry.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

1 Year

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Measure	Description	Time Frame
Major adverse cardiac events (MACE)		1 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects who recieved intracoronary OCT imaging during cardiac catheterization are eligible for this registry.

Exclusion Criteria:

None

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Subjects who recieved intracoronary OCT imaging during cardiac catheterization are eligible for this registry.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hainan General Hospital	Recruiting	Haikou	Hainan	570311	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

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