NCT05595278

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 26, 2022

Completed
18 days until next milestone

Study Start

First participant enrolled

November 13, 2022

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 13, 2023

Completed
Last Updated

November 15, 2022

Status Verified

November 1, 2022

Enrollment Period

7 months

First QC Date

October 23, 2022

Last Update Submit

November 10, 2022

Conditions

Myocardial Infarction

Outcome Measures

Primary Outcomes (3)

  • (CBC)

    measurement of CBC will be performed at the time of admission and by the time of discharge.

    6 months

  • (NT-proBNP

    measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge.

    6 months

  • (cTnT)

    measurement of cTnT levels will be performed at the time of admission and by the time of discharge

    6 months

Interventions

(CBC) ,(NT-proBNP) ,(cTnT)DIAGNOSTIC_TEST

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.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

• All patients included in the study will be subjected to: 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

You may not qualify if:

  • Patient with:
  • Decompensated heart failure
  • Pulmonary hypertention
  • Acute pulmonary embolism
  • Septic shock

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

Location

Related Publications (3)

  • Nascimento BR, Brant LCC, Marino BCA, Passaglia LG, Ribeiro ALP. Implementing myocardial infarction systems of care in low/middle-income countries. Heart. 2019 Jan;105(1):20-26. doi: 10.1136/heartjnl-2018-313398. Epub 2018 Sep 29.

    PMID: 30269080BACKGROUND

  • Barberi C, van den Hondel KE. The use of cardiac troponin T (cTnT) in the postmortem diagnosis of acute myocardial infarction and sudden cardiac death: A systematic review. Forensic Sci Int. 2018 Nov;292:27-38. doi: 10.1016/j.forsciint.2018.09.002. Epub 2018 Sep 17.

    PMID: 30269044BACKGROUND

  • Alaour B, Liew F, Kaier TE. Cardiac Troponin - diagnostic problems and impact on cardiovascular disease. Ann Med. 2018 Dec;50(8):655-665. doi: 10.1080/07853890.2018.1530450. Epub 2018 Nov 21.

    PMID: 30265127BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Blood Cell Count

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Cell CountCytological TechniquesClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisHematologic TestsInvestigative TechniquesCell Physiological PhenomenaBlood Physiological PhenomenaCirculatory and Respiratory Physiological Phenomena

Central Study Contacts

Hemat k Maarouf, resident doctor

CONTACT

01063296647hemat011219@med.sohag.edu.eg

Abdelhady R Abdel-Gawad, assistant professor

CONTACT

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor at clinical and chemical pathology department

Study Record Dates

First Submitted

October 23, 2022

First Posted

October 26, 2022

Study Start

November 13, 2022

Primary Completion

June 13, 2023

Study Completion

July 13, 2023

Last Updated

November 15, 2022

Record last verified: 2022-11

Locations

EG(1)