- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05595278
Red Cell Distribution Width,,NT-proBNP and cTnT in Acute Myocardial Infraction Patient
November 10, 2022 updated by: Hemat Kamel Maarouf, Sohag University
Detrmination of the Relationship Between Red Cell Distribution Width ,NT-proBNP and cTnT in Acute Myocardial Infraction Patients
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.
Study Overview
Status
Not yet recruiting
Conditions
Intervention / Treatment
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.
All patients included in the study will be subjected to:
Full history:
- Personal history: e.g. age, sex and smoking.
- Family history of cardiac diseases
- 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:
- Routine investigation in the form of CBC including RDW
- Specific investigation which include NT-proBNP and cTnT
Study Type
Observational
Enrollment (Anticipated)
30
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Hemat k Maarouf, resident doctor
- Phone Number: 01063296647
- Email: hemat011219@med.sohag.edu.eg
Study Contact Backup
- Name: Abdelhady R Abdel-Gawad, assistant professor
Study Locations
-
-
-
Sohag, Egypt
- Sohag University Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
• All patients included in the study will be subjected to:
Full history:
- Personal history: e.g. age, sex and smoking.
- Family history of cardiac diseases
- 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:
- Routine investigation in the form of CBC including RDW
- Specific investigation which include NT-proBNP and cTnT
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Only
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
(CBC)
Time Frame: 6 months
|
measurement of CBC will be performed at the time of admission and by the time of discharge.
|
6 months
|
|
(NT-proBNP
Time Frame: 6 months
|
measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge.
|
6 months
|
|
(cTnT)
Time Frame: 6 months
|
measurement of cTnT levels will be performed at the time of admission and by the time of discharge
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
November 13, 2022
Primary Completion (Anticipated)
June 13, 2023
Study Completion (Anticipated)
July 13, 2023
Study Registration Dates
First Submitted
October 23, 2022
First Submitted That Met QC Criteria
October 23, 2022
First Posted (Actual)
October 26, 2022
Study Record Updates
Last Update Posted (Actual)
November 15, 2022
Last Update Submitted That Met QC Criteria
November 10, 2022
Last Verified
November 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Soh-Med-2210-05
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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