Myocardial InfarctionNCT05677503
Determination of the Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients
An observational study of Myocardial Infarction, run by Sohag University.
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?
- Ages 18 to 80 years
- Conditions the study is for
- Myocardial Infarction
- What is being tested?
- CBC, (NT-proBNP) and (cTnT)
- How many people
- 30 participants
- Where
- No sites listed yet
- Study dates
- 15 Jan 2023to 30 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 18 to 80 years
- All sexes
- No healthy volunteers
- 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
Who cannot join
- Patient with
- Decompensated heart failure
- Pulmonary hypertention
- Acute pulmonary embolism
- Septic shock
About this study
Official title: Determination of the Relationship Between Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction 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.
- 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.
CBCDiagnostic 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
What is being measured
The primary outcome is the main question the study is designed to answer.
complete blood count (CBC)
measurement of CBC levels will be performed
Measured: 7 months
Level of (NT-proBNP)
measurement of serum NT-proBNP level will be performed
Measured: 7 months
Level of (cTnT)
measurement of cTnT level will be performed
Measured: 7 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2023
- Study start15 Jan 2023 (estimated)
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- 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
- NCT05677503
- Sponsor's protocol ID
- Sohag_Med_22_12_07
- Status last verified
- Jan 2023
- First submitted
- 23 Dec 2022
- Last updated
- 12 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Determination of the Relationship Between Red Cell Distribution Width, NT-proBNP and cTnT in Acute Myocardial Infarction Patients
- ClinicalTrials.gov ID
- NCT05677503
- Acronym / sponsor ID
- Sohag_Med_22_12_07
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 15 Jan 2023 (estimated)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jul 2023 (estimated)
- First posted
- 10 Jan 2023 (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.
- 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
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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
Key exclusion criteria (5 listed)
- Patient with
- 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 |
|---|---|---|
| CBCmeasurement of CBC will be performed at the time of admission and by the time of discharge | Diagnostic test | – |
| (NT-proBNP)measurement of serum NT-proBNP levels will be performed at the time of admission and by the time of discharge | Diagnostic test | – |
| (cTnT)measurement of cTnT levels will be performed at the time of admission and by the time of discharge | Diagnostic test | – |
Primary outcome
complete blood count (CBC)
Time frame: 7 months
measurement of CBC levels will be performed
Level of (NT-proBNP)
Time frame: 7 months
measurement of serum NT-proBNP level will be performed
Level of (cTnT)
Time frame: 7 months
measurement of cTnT level will be performed
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Myocardial Infarction, run by Sohag University.
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 12 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complete blood count (CBC) (time frame: 7 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?
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 12 Jan 2023.