Prognostic Value of Surem TRAF3IP2 Level in Patients With... | NCT06038994

Studies
Prognostic Value of Surem TRAF3IP2 Level in Patients With Acute Myocardial Infarction

NCT06038994

Sponsor

Nanjing Medical University

Status

Unknown status

Last Update Posted

Sep 15, 2023Actual

Enrollment

200Estimated

Phase

Not provided

Conditions

Myocardial Infarction, Acute

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

Apr 30, 2024Estimated

Completion Date

Apr 30, 2025Estimated

First Submitted Date

Sep 7, 2023

First Submission Date that Met QC Criteria

Sep 8, 2023

First Posted Date

Sep 15, 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 15, 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 prognostic value of surem TRAF3IP2 levels in patients with acute myocardial infarction

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 diagnosed with acute myocardial infarction who receive coronary angiography will be enrolled. Their surem TRAF3IP2 levels will be tested using ELASA. The association of surem TRAF3IP2 levels with the major adverse cardiac events 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

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Patients with acute myocardial infarction who experienced CAG		Patients with acute myocardial infarction 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 acute myocardial infarction who experienced CAG

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
MACEs (major adverse cardiac events)	MACEs were defined as a composite of cardiac death, hospitalization for myocardial infarction or heart failure	1 year

Secondary Outcomes

Measure	Description	Time Frame
cardiac death	and death due to cardiac reasons, such as myocardial infarction or heart failure	1 year
hospitalization for myocardial infarction or heart failure	hospitalization for myocardial infarction or heart failure

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with acute myocardial infarction
patients received coronary angiography
invasive management within 72 h of hospital admission

Exclusion Criteria:

NYHA III-IV
malignant tumor
acute infection
thyroid dysfunction
Life expectancy of b1 y
Unsuitable for PCI

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

All patients with acute myocardial infarction who received coronary angiography well enrolled in Huai'an First People's Hospital

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

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

Overall Officials

Name	Affiliation	Role
Shuren Ma, MD.	NJMU	Principal Investigator

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

There is not a plan to make IPD available.

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D009203	Myocardial Infarction

Ancestor Terms

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

Browse Leaves

Not provided

Browse Branches

Not provided