Myocardial Infarction, AcuteNCT05692752
Expression of microRNA-133a and microRNA-208b in Acute Myocardial Infarction
An observational study of Myocardial Infarction, Acute, run by Islamia University of Bahawalpur at 1 site in Egypt.
Trial summary
Cardiac-enriched micro-RNAs (miRNAs), micro RNA 208b and 133a(MiR-208b, MiR-133a)) corresponds to the health and disorders of the cardiovascular system. An intron of the cardiac myosin heavy chain gene MYH7 encodes miR-208b. It is found on chromosome 14 in humans. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction, Acute
- How many people
- 10 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2022to 14 Jan 2023
- How long will I take part?
- 3 Days
- 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 35 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patient registering at the Coronary Care Unit at Ain-shams University hospital German University in Cairo, New Cairo City,.Egypt
Who may be able to join
- Patients diagnosed with ST-Elevated Myocardial Infarction will be identified at the Coronary Care Unit at Ain-shams University hospital
- Acute episode of Myocardial Infarction
- With No history of previous Myocardial Infarction Treatment
Who cannot join
- Patients not diagnosed with ST-Elevated Myocardial Infarction and healthy at the Coronary Care Unit at Ain-shams 2. University hospital
- Previously Known patients of Myocardial infacrtion
- Previous medication
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Biochemistry Department, Faculty of Pharmacy and Biotechnology, German University in Cairo, Main Entrance Al Tagamoa Al Khames
Cairo, 11835
About this study
Official title: Expression of microRNA-133a and microRNA-208b in Acute Myocardial Infarction Egyptian Patients
Cardiac-enriched micro-RNAs (miRNAs), micro RNA 208b and 133a(MiR-208b, MiR-133a)) corresponds to the health and disorders of the cardiovascular system. An intron of the cardiac myosin heavy chain gene MYH7 encodes miR-208b. It is found on chromosome 14 in humans. Identify new diagnostic biomarkers based on miRNAs, researchers examine the expression of miR-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cardiac troponine (cTnl) and Creatine kinase-MB (CK-MB).
Read the detailed description
The 98% of human genes are non-coding RNA, which is further divided into long non-coding RNA (lncRNA, > 200 bp) and short non-coding RNA (200 bp, including microRNA (miRNA) and circular RNA). More than 2000 human miRNAs have been discovered, and it seems that they regulate around 60% of human genes.Through a number of pathways, miRNAs control the development, re-modelling, and regeneration of the heart as well as endothelial function, vasculo-genesis, and neoangiogenesis. 30% of the genes in the human genome are regulated by about 1000 miRNAs. Endogenous miRNAs are 19-22 nucleotide single-stranded RNA molecules that frequently target the 3' untranslated regions (3'-UTR) of mRNAs to regulate gene expression at the post-transcriptional level in physiological processes, disease development, and conditions like cancer, autoimmune and inflammatory diseases, neuro-degenerative diseases, and cardiovascular diseases. Cardiac-enriched miRNAs, MiR-208 in health and disorders of the cardiovascular system are investigated.
Identify new diagnostic biomarkers based on miRNAs, researchers examine the expression of miR-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cTnl and CK-MB.
- Conditions
- Myocardial Infarction, Acute
- Being tested
- No intervention
- Medical subject headings
- Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
Also called Expression of miR-133a & 208b
Expression of miR-133a \&208b at 4, 8, 12, 24 and 48 hours from the first appearance of myocardial infarction (MI) symptoms
| Study group | Role | What they receive |
|---|---|---|
| Test Group | The study group included 10 patients,
1. men and women
2. between age of 35-60 year
3. chest pain lasting for at least 30 minutes,
4. electrocardiogram (ECG) finding that display ST-segment elevation (STEMI) Receives: Other: No intervention | |
| Control Group | The study group included 10 patients,
1. men and women
2. between age of 35-60 year
3. having no complaint of health issue, Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Expression of miR-133a
Expression during episodes of myocardial infarction
Measured: 04 hours from the onset of the infarct
Expression of miR-133a
Expression during episodes of myocardial infarction
Measured: 08 hours from the onset of the infarct
Expression of miR-133a
Expression during episodes of myocardial infarction
Measured: 12 hours from the onset of the infarct
Expression of miR-133a
Expression during episodes of myocardial infarction
Measured: 24 hours from the onset of the infarct
Expression of miR-133a
Expression during episodes of myocardial infarction
Measured: 48 hours from the onset of the infarct
Expression of miR-208b
Expression during episodes of myocardial infarction
Measured: 04 hours from the onset of the infarct
Expression of miR-208b
Expression during episodes of myocardial infarction
Measured: 08 hours from the onset of the infarct
Expression of miR-208b
Expression during episodes of myocardial infarction
Measured: 12 hours from the onset of the infarct
Expression of miR-208b
Expression during episodes of myocardial infarction
Measured: 24 hours from the onset of the infarct
Expression of miR-208b
Expression during episodes of myocardial infarction
Measured: 48 hours from the onset of the infarct
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2023
- Study start28 Dec 2022
- Primary completion10 Jan 2023
- Study completion14 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Myocardial Infarction, AcuteStudies 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
- 10 participants (actual)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Islamia University of Bahawalpur
- Sponsor type
- University, hospital or other
- Collaborators
- German University in Cairo
- Responsible party
- Principal investigator, Hafiz Abdul Sattar Hashmi, Islamia University of Bahawalpur
- Investigators
- Sally I Hassanien, Ph.D, Principal investigator, Biochemistry Department German University in Cairo, 11835, Cairo, EgyptHafiz A Sattar, M.Phil, Principal investigator, University College of Conventional Medicine, The Islamia University of Bahawalpur, Punjab, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05692752
- Sponsor's protocol ID
- UCCM/2022/EGT/01
- Status last verified
- Jan 2023
- First submitted
- 22 Dec 2022
- Last updated
- 20 Jan 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified data will be published.
Study at a glance
From the registry record, last updated by the sponsor on 20 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Expression of microRNA-133a and microRNA-208b in Acute Myocardial Infarction Egyptian Patients
- ClinicalTrials.gov ID
- NCT05692752
- Acronym / sponsor ID
- UCCM/2022/EGT/01
- Conditions
- Myocardial Infarction, Acute
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Islamia University of BahawalpurUniversity, hospital or other
- Collaborators
- German University in Cairo
- Study start
- 28 Dec 2022 (actual)
- Primary completion
- 10 Jan 2023 (actual)
- Study completion
- 14 Jan 2023 (actual)
- First posted
- 20 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.
Cardiac-enriched micro-RNAs (miRNAs), micro RNA 208b and 133a(MiR-208b, MiR-133a)) corresponds to the health and disorders of the cardiovascular system. An intron of the cardiac myosin heavy chain gene MYH7 encodes miR-208b. It is found on chromosome 14 in humans. Identify new diagnostic biomarkers based on miRNAs, researchers examine the expression of miR-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cardiac troponine (cTnl) and Creatine kinase-MB (CK-MB).
Detailed description
The 98% of human genes are non-coding RNA, which is further divided into long non-coding RNA (lncRNA, > 200 bp) and short non-coding RNA (200 bp, including microRNA (miRNA) and circular RNA). More than 2000 human miRNAs have been discovered, and it seems that they regulate around 60% of human genes.Through a number of pathways, miRNAs control the development, re-modelling, and regeneration of the heart as well as endothelial function, vasculo-genesis, and neoangiogenesis. 30% of the genes in the human genome are regulated by about 1000 miRNAs. Endogenous miRNAs are 19-22 nucleotide single-stranded RNA molecules that frequently target the 3' untranslated regions (3'-UTR) of mRNAs to regulate gene expression at the post-transcriptional level in physiological processes, disease development, and conditions like cancer, autoimmune and inflammatory diseases, neuro-degenerative diseases, and cardiovascular diseases. Cardiac-enriched miRNAs, MiR-208 in health and disorders of the cardiovascular system are investigated.
Identify new diagnostic biomarkers based on miRNAs, researchers examine the expression of miR-133a and 208b at various time points (04 hours, 08 hours, 12 hours, 24 hours, 48 hours) following the development of the infarct and compared it to the traditional myocardial infarction biomarkers cTnl and CK-MB.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Test Group | – | Other: No interventionThe study group included 10 patients, 1. men and women 2. between age of 35-60 year 3. chest pain lasting for at least 30 minutes, 4. electrocardiogram (ECG) finding that display ST-segment elevation (STEMI) |
| Control Group | – | Other: No interventionThe study group included 10 patients, 1. men and women 2. between age of 35-60 year 3. having no complaint of health issue, |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patient registering at the Coronary Care Unit at Ain-shams University hospital German University in Cairo, New Cairo City,.Egypt
Key inclusion criteria (3 listed)
- Patients diagnosed with ST-Elevated Myocardial Infarction will be identified at the Coronary Care Unit at Ain-shams University hospital
- Acute episode of Myocardial Infarction
- With No history of previous Myocardial Infarction Treatment
Key exclusion criteria (3 listed)
- Patients not diagnosed with ST-Elevated Myocardial Infarction and healthy at the Coronary Care Unit at Ain-shams 2. University hospital
- Previously Known patients of Myocardial infacrtion
- Previous medication
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 |
|---|---|---|
| No interventionAlso: Expression of miR-133a & 208bExpression of miR-133a \&208b at 4, 8, 12, 24 and 48 hours from the first appearance of myocardial infarction (MI) symptoms | Other | Control Group, Test Group |
Primary outcome
Expression of miR-133a
Time frame: 04 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-133a
Time frame: 08 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-133a
Time frame: 12 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-133a
Time frame: 24 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-133a
Time frame: 48 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-208b
Time frame: 04 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-208b
Time frame: 08 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-208b
Time frame: 12 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-208b
Time frame: 24 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Expression of miR-208b
Time frame: 48 hours from the onset of the infarct
Expression during episodes of myocardial infarction
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jan 2023.
- Individual participant dataSharing planned: No. De-identified data will be published.
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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.
Sally I Hassanien, Ph.D principal investigator
Biochemistry Department German University in Cairo, 11835, Cairo, Egypt
Hafiz A Sattar, M.Phil principal investigator
University College of Conventional Medicine, The Islamia University of Bahawalpur, Punjab, Pakistan
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, Acute, run by Islamia University of Bahawalpur 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 3 inclusion and 3 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: finished, as of the sponsor's last update on 20 Jan 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Expression of miR-133a (time frame: 04 hours from the onset of the infarct). The study lists 10 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 20 Jan 2023.