Myocardial InfarctionNCT05595278
Red Cell Distribution Width,,NT-proBNP and cTnT in Acute Myocardial Infraction Patient
An observational study of Myocardial Infarction, run by Sohag University at 1 site in Egypt.
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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- (CBC) ,(NT-proBNP) ,(cTnT)
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Nov 2022to 13 Jul 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patient with:
- Decompensated heart failure
- Pulmonary hypertention
- Acute pulmonary embolism
- Septic shock
Trial locations and contacts
1 site in 1 country.
Abdelhady R Abdel-Gawad, assistant professor contact
About this study
Official title: 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.
Read the 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
- Conditions
- Myocardial Infarction
- Being tested
- (CBC) ,(NT-proBNP) ,(cTnT)
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
(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.
What is being measured
The primary outcome is the main question the study is designed to answer.
(CBC)
measurement of CBC will be performed at the time of admission and by the time of discharge.
Measured: 6 months
(NT-proBNP
measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge.
Measured: 6 months
(cTnT)
measurement of cTnT levels will be performed at the time of admission and by the time of discharge
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2022
- Study start13 Nov 2022 (estimated)
- Primary completion13 Jun 2023 (estimated)
- Study completion13 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hemat Kamel Maarouf, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05595278
- Sponsor's protocol ID
- Soh-Med-2210-05
- Status last verified
- Nov 2022
- First submitted
- 23 Oct 2022
- Last updated
- 15 Nov 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 30269080Barberi 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.
PubMed 30269044Alaour 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.
PubMed 30265127
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Detrmination of the Relationship Between Red Cell Distribution Width ,NT-proBNP and cTnT in Acute Myocardial Infraction Patients
- ClinicalTrials.gov ID
- NCT05595278
- Acronym / sponsor ID
- Soh-Med-2210-05
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Nov 2022 (estimated)
- Primary completion
- 13 Jun 2023 (estimated)
- Study completion
- 13 Jul 2023 (estimated)
- First posted
- 26 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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 design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (5 listed)
- Decompensated heart failure
- Pulmonary hypertention
- Acute pulmonary embolism
- Septic shock
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| (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. | Diagnostic test | – |
Primary outcome
(CBC)
Time frame: 6 months
measurement of CBC will be performed at the time of admission and by the time of discharge.
(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.
(cTnT)
Time frame: 6 months
measurement of cTnT levels will be performed at the time of admission and by the time of discharge
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2022.
- Background: PubMed 30269080Nascimento 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.
- Background: PubMed 30269044Barberi 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.
- Background: PubMed 30265127Alaour 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Abdelhady R Abdel-Gawad, assistant professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hemat k Maarouf, resident doctor (01063296647, hemat011219@med.sohag.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
(CBC) (time frame: 6 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05595278, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Nov 2022; AzTrials last refreshed its copy on 31 Oct 2026.