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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05595278
Other study ID # Soh-Med-2210-05
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date November 13, 2022
Est. completion date July 13, 2023

Study information

Verified date November 2022
Source Sohag University
Contact Hemat k Maarouf, resident doctor
Phone 01063296647
Email hemat011219@med.sohag.edu.eg
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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. - 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


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 30
Est. completion date July 13, 2023
Est. primary completion date June 13, 2023
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - patients diagnosed as acute myocardial infarction and admitted to department of cardiology and cardiac care unit at Sohag cardiology and gastroenterology center according to inclusion and exclution criteria Exclusion Criteria: Patient with: - Decompensated heart failure - Pulmonary hypertention - Acute pulmonary embolism - Septic shock

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
(CBC) ,(NT-proBNP) ,(cTnT)
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.

Locations

Country Name City State
Egypt Sohag University Hospital Sohag

Sponsors (1)

Lead Sponsor Collaborator
Sohag University

Country where clinical trial is conducted

Egypt, 

References & Publications (3)

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. Review. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary (CBC) measurement of CBC will be performed at the time of admission and by the time of discharge. 6 months
Primary (NT-proBNP measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge. 6 months
Primary (cTnT) measurement of cTnT levels will be performed at the time of admission and by the time of discharge 6 months
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