Relationship Between Level of GPCR Autoantibodies and Car... | NCT05368584

Studies
Relationship Between Level of GPCR Autoantibodies and Cardiac Structure & Funtions Based on UCG and CMR

NCT05368584

Sponsor

Beijing Friendship Hospital

Status

Unknown status

Last Update Posted

May 10, 2022Actual

Enrollment

1Estimated

Phase

Not provided

Conditions

STEMI

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

May 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 7, 2022Actual

Primary Completion Date

Dec 2022Estimated

Completion Date

Dec 2022Estimated

First Submitted Date

May 6, 2022

First Submission Date that Met QC Criteria

May 9, 2022

First Posted Date

May 10, 2022Actual

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

May 9, 2022

Last Update Posted Date

May 10, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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 study is a prospective cohort study，we want to observe the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI;and combined with different cardiovascular antibody levels and various indicators, evaluate the impact of ischemia-reperfusion injury and prognosis in STEMI patients after emergency PCI.

Detailed Description

This study mainly observed the changes of different cardiovascular antibody levels in STEMI patients undergoing emergency PCI by measuring autoantibodies; and the changes of autoantibodies in STEMI patients compared with coronary angiography-negative patients. At the same time, combined with different cardiovascular antibody levels and various indicators, the effect of ischemia-reperfusion injury and prognosis after emergency PCI in STEMI patients was evaluated. The correlation between autoantibody changes and imaging indicators in STEMI patients was evaluated by cardiac color Doppler ultrasound and CMR.

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

1Estimated

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA OD values	About 10ml of venous blood was collected on the second day of admission, serum was separated, and the OD values of β1-AA, β2-AA, α1-AA, M2-AA and AT1-AA were detected by ELISA.	Admission Baseline

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

STEMI patients meet the diagnostic criteria of "Guidelines for the Diagnosis and Treatment of Acute ST-segment Elevation Myocardial Infarction (2015)"; ②STMEI patients undergoing emergency PCI should undergo emergency PCI within 12 hours of onset at Beijing Friendship Hospital affiliated to Capital Medical University; ③ The selected patients were able to complete the MRI and STE examinations; ④ They agreed to be enrolled in the trial and signed the informed consent.

Exclusion Criteria:

Past myocardial infarction or revascularization (PCI or CABG); ②Congestive heart failure LVEF<40%; ③Atrial fibrillation; ④Renal insufficiency (GFR<30 ml/min); disease; ⑥ rheumatic immune system disease; ⑦ malignant tumor; ⑧ claustrophobia; ⑨ contraindication to CMR;

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

① Patients with acute ST-segment elevation myocardial infarction (STEMI) who underwent emergency PCI in Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University. ②In the Beijing Friendship Hospital (Xicheng District) affiliated to Capital Medical University, coronary angiography showed negative coronary angiography in patients with non-coronary heart disease.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D000072657	ST Elevation Myocardial Infarction

Ancestor Terms

ID	Term
D009203	Myocardial Infarction
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided