Neopterin in Acute Coronary Syndrome Patients | NCT05080387

Studies
Neopterin in Acute Coronary Syndrome Patients

NCT05080387

Sponsor

Assiut University

Status

Unknown status

Last Update Posted

Feb 15, 2022Actual

Enrollment

50Estimated

Phase

Not provided

Conditions

Neopterin in Acute Coronary Syndrome Patients

Interventions

Blood sample

Countries

Egypt

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

Oct 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

Nov 1, 2022Estimated

Primary Completion Date

Oct 1, 2023Estimated

Completion Date

Oct 1, 2024Estimated

First Submitted Date

Oct 5, 2021

First Submission Date that Met QC Criteria

Oct 5, 2021

First Posted Date

Oct 15, 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

Feb 14, 2022

Last Update Posted Date

Feb 15, 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

Measurement of neopterin in ACS patients

Detailed Description

Detect level of neopterin in ACS patients to detect whether there is relation or not between ACS and neopterin
Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS patients
Detect relation between neopterin level and in hospital events

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

50Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Blood sample	Other	Blood samples will obtained for measurement of neopterin level through ELIZA

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To detect whether there is association between neopterin and ACS or not	To detect whether there is association between neopterin and ACS or not	72 hours

Secondary Outcomes

Measure	Description	Time Frame
Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS and detection of relation between neopterin level and in hospital events	Detection of relation between neopterin and cardiac enzymes as CK and troponine in ACS and detection of relation between neopterin level and in hospital events	72 hours

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All patient of sample size admitted to cardiology departmentof Assiut university hospital with :
1. Acute typical chest pain
2. Positive cardiac enzymes
3. ECG show recent ischemic changes
4. ECHO show SWMA

Exclusion Criteria:

Patients not fulfill inclusion criteria.
Patients with other diseases which may cause increase of neopterin level as viral infections, intracellular bacteria or parasites infections, certain malignancies, allograft rejection

Accepts Healthy Volunteers

Not provided

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 of sample size admitted to cardiology department with ACS.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Mina Khairy Alyshaa Gorgy, Resident	Contact	01227386406		Minakhairy1995@gmail.com
Yehia Taha keshik, Prof. Doctor	Contact	01223971269

Overall Officials

Name	Affiliation	Role
Magdy Ibrahim Aldesowky, Lecturer	Assiut University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Assiut university	Recruiting	Asyut		AssiutU	Egypt

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Share if participants agree

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D001800	Blood Specimen Collection

Ancestor Terms

ID	Term
D013048	Specimen Handling
D019411	Clinical Laboratory Techniques
D019937	Diagnostic Techniques and Procedures
D003933	Diagnosis

Browse Leaves

Not provided

Browse Branches

Not provided