Determination of the Red Cell Distribution Width, NT-proB... | NCT05677503

Studies
Determination of the Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients

NCT05677503

Sponsor

Sohag University

Status

Unknown status

Last Update Posted

Jan 12, 2023Actual

Enrollment

30Estimated

Phase

Not provided

Conditions

Myocardial Infarction

Interventions

CBC
(NT-proBNP)
(cTnT)

Countries

Not provided

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

Annotation Module

Unposted Annotation

Unposted Responsible Party

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2023

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 15, 2023Estimated

Primary Completion Date

Jun 30, 2023Estimated

Completion Date

Jul 30, 2023Estimated

First Submitted Date

Dec 23, 2022

First Submission Date that Met QC Criteria

Jan 9, 2023

First Posted Date

Jan 10, 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

Jan 11, 2023

Last Update Posted Date

Jan 12, 2023Actual

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

the study is to investigate the relationship of several parameters of complete blood count (CBC) including RDW with N-terminal pro-B-type natriuretic peptide (NT-proBNP) and cardiac troponin T (cTnT) in a cohort of acute myocardial infarction (AMI) patients.

Detailed Description

Patients and methods:

Type of study: Observational prospective study
Place of study: Sohag cardiology and gastroenterology center, department of cardiology and cardiac care unit.
Ethical considerations: This research will be revised by the Scientific Ethical Committee of Sohag University Hospital. Consents will be taken from all patients.
Study Methods:
- A prospective study on 30 patients diagnosed as acute myocardial infarction on which measurement of CBC, serum NT-proBNP, and cTnT levels will be performed at the time of admission and by the time of discharge.
  1. Full history:
    1. Personal history: e.g. age, sex and smoking.
    2. Family history of cardiac diseases
    3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history
  2. Detailed clinical examination
  3. Electrocardiogram
  4. Laboratory investigation:
    1. Routine investigation in the form of CBC including RDW
    2. Specific investigation which include NT-proBNP and cTnT

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

30Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description
CBC	Diagnostic Test	measurement of CBC will be performed at the time of admission and by the time of discharge
(NT-proBNP)	Diagnostic Test	measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge
(cTnT)	Diagnostic Test	measurement of cTnT levels will be performed at the time of admission and by the time of discharge

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
complete blood count (CBC)	measurement of CBC levels will be performed	7 months
Level of (NT-proBNP)	measurement of serum NT-proBNP level will be performed	7 months
Level of (cTnT)	measurement of cTnT level will be performed	7 months

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

patients diagnosed as acute myocardial infarction

Exclusion Criteria:

Patient with

Decompensated heart failure
Pulmonary hypertention
Acute pulmonary embolism
Septic shock

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

_All patients included in the study will be subjected to:

Full history:
1. Personal history: e.g. age, sex and smoking.
2. Family history of cardiac diseases
3. Medical history of: Hypertension, Ischemic heart disease, prior coronary artery bypass grafting, Prior Percutaneous coronary intervention, Prior Stroke, Prior Atrial fibrillation, therapeutic history
Detailed clinical examination
Electrocardiogram
Laboratory investigation:
1. Routine investigation in the form of CBC including RDW
2. Specific investigation which include NT-proBNP and cTnT

Sampling Method

Probability Sample

Type	Date	Date Unknown
Release	Feb 18, 2024
Reset	Jul 26, 2024

Release Date	Unrelease Date	Unrelease Date Unknown	Reset Date	MCP Release Number
Feb 18, 2024			Jul 26, 2024

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