The Surem TRAF3IP2 Level and Atherosclerotic Plaque Devel... | NCT05945394

Studies
The Surem TRAF3IP2 Level and Atherosclerotic Plaque Development in Human

NCT05945394

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Sep 13, 2023Actual

Enrollment

800Estimated

Phase

Not provided

Conditions

Coronary Heart Disease, Susceptibility to, 1

Interventions

No intervention

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

Sep 2023

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

Sep 1, 2023Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Dec 31, 2023Estimated

First Submitted Date

Jun 29, 2023

First Submission Date that Met QC Criteria

Jul 13, 2023

First Posted Date

Jul 14, 2023Actual

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

Sep 8, 2023

Last Update Posted Date

Sep 13, 2023Actual

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

To evaluate the association of surem TRAF3IP2 levels with the atherosclerotic plaque development in human

Detailed Description

Previous study had concluded that TRAF3IP2 plays a causal role in atherosclerotic plaque development and vulnerability in mice. However, no human data was available. In the present study, patients who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the atherosclerotic plaque will be evaluated.

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

Retention

Enrollment

800Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with suspected CHD who experienced CAG		Patients with suspected coronary heart disease who experienced coronary angiography	Other: No intervention

Interventions

Name	Type	Description	Arm Group Labels	Other Names
No intervention	Other	This is an obvertional study, and there is no intervention.	Patients with suspected CHD who experienced CAG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
stenosis of coronary artery	The stenosis of coronary artery based on the results of coronary angiography	1 week

Secondary Outcomes

Measure	Description	Time Frame
coronary artery calcium	The coronary artery calcification based on the results of coronary angiography	1 week

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with suspected coronary heart disease
patients received coronary angiography

Exclusion Criteria:

NYHA III-IV
malignant tumor
acute infection
thyroid dysfunction

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

90 Years

Standard Ages

AdultOlder Adult

Study Population

Patients with suspected coronary heart disease who experienced coronary angiography

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Geng Jin, MD	Contact	+86-17753124846		gj885258@163.com

Overall Officials

Name	Affiliation	Role
Ma Shuren, MD	NJMU	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Huai'an First People's Hospital	Recruiting	Huai'an	Jiangsu	223300	China

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003327	Coronary Disease

Ancestor Terms

ID	Term
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases
D014652	Vascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided