Relationship Between Serum N/OFQ and Brain-heart Syndrome | NCT05344794

Studies
Relationship Between Serum N/OFQ and Brain-heart Syndrome

NCT05344794

Sponsor

Zheng Guo

Status

Unknown status

Last Update Posted

Feb 21, 2023Actual

Enrollment

120Estimated

Phase

Not provided

Conditions

Cerebral-Cardiac Syndrome

Interventions

Enzyme-linked immunosorbent assay

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

Feb 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

May 1, 2023Estimated

Primary Completion Date

Sep 30, 2023Estimated

Completion Date

Oct 31, 2023Estimated

First Submitted Date

Apr 18, 2022

First Submission Date that Met QC Criteria

Apr 18, 2022

First Posted Date

Apr 25, 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

Feb 17, 2023

Last Update Posted Date

Feb 21, 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

Choosing the neurology patients in the Second Hospital of Shanxi Medical University, diagnosed with patients with cerebral syndrome into the experimental group; patients who did not have cerebral syndrome included in the control group, and all selected people had no intimate relationship with each other.Specimen collecting control group and the study group serum inflammatory factor IL-6, solvent peptide and catecholamine content. The difference between the two groups of data was observed.According to the literature, it is guess: The solitary peptide content of the experimental group will be higher than the control group, and is positively correlated with IL-6, catecholamine content.The difference was statistically significant.

Detailed Description

Not provided

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

3 Days

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
CCS group		Patients with cerebral syndrome diagnosed by the Second Hospital of Shanxi Medical University	Diagnostic Test: Enzyme-linked immunosorbent assay
Control group		Patients who have not had a cerebral syndrome in ischemic stroke	Diagnostic Test: Enzyme-linked immunosorbent assay

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Enzyme-linked immunosorbent assay	Diagnostic Test	Serum N/OFQ , IL-6 and NE levels were detected.	CCS group Control group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
N/OFQ	Serum N/OFQ levels	24 hours
IL-6	Serum IL-6 levels	24 hours
NE	Serum NE levels	24 hours

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Diagnostic criteria in compliance with cerebral syndrome
Acute ischemic stroke patients in line with the "Chinese Acute Ischemic Stroke Treatment Guide 2018" related diagnostic criteria
There is no intimate relationship between all selected people and knows this study, and signs informed consent

Exclusion Criteria:

Heart-type cerebral infarction, hemorrhagic stroke, brain tumor and past intracranial hemorrhage
Complicated with severe cardiovascular complications (such as coronary heart disease, acute coronary syndrome, acute myocardial infarction, chronic heart failure, atrial fibrillation, etc.)
Complicated with severe liver and kidney dysfunction (such as coagulous dysfunction, cirrhosis, nephrotic syndrome , Renal failure, etc.)
Complicated with severe diabetes complications (such as diabetic nephropathy, diabetic foot, diabetic acidosis, high blood sugar hypertonic state, diabetes coronary heart disease, etc.)
Complicated with Psychological disease
Complicated with chronic obstructive pulmonary disease(COPD)
BMI> 40

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Patients in the Second Hospital of Shanxi Medical University from May 2022 to October 2023

Sampling Method

Non-Probability Sample