Myocardial InfarctionNCT05788640
Circadian and Seasonal Variation in Acute Myocardial Infarction
An observational study of Myocardial Infarction, run by Assiut University at 1 site in Egypt.
Trial summary
Circadian and seasonal variation in acute myocardial infarction . Read more about this study
- Who is it for?
- Ages 16 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Myocardial Infarction
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Feb 2026
- 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 16 to 75 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Sample size was calculated using Epi- Info7. Expected frequency of cardiac onset is 15%. Based on this frequency and with a confidence limits of 6% and a confidence level of 90%, the sample needed for the study was estimated to be about from 138 patients and 196 at 95% CI .The sample will be calculated in the seasons of extreme seasonal changes at 2023, 2024
Who may be able to join
- 1.All patients above (16) years old 2.Complaint occur during acute climate changes
Who cannot join
- 1.Patients below 16 years old 2.Complaint during normal climate
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Assiut University
Asyut
Fady Nabil, Resident, 01271790912, Fadynabil7777@gmail.com
Hanaan Sharaf, Prof, 01005035006, Dr_Hanansharaf@yahoo.com
About this study
Official title: Circadian and Seasonal Variation in Acute Myocardial Infarction in Relation to Blood Viscosity and Outcome Among Adults Attending the Main Assiut University Hospital
Circadian and seasonal variation in acute myocardial infarction .
Read the detailed description
Circadian and seasonal variation in acute myocardial infarction and relation between circadian rhythm and seasonal variations with biological and physiological markes of normal human being.
- Conditions
- Myocardial Infarction
- Medical subject headings
- Myocardial Infarction
What is being measured
The primary outcome is the main question the study is designed to answer.
Circadian and seasonal variation in acute myocardial infarction
Reporting the presence or absence of difference in electrocardiogram ,Echo and d-Dimer between patients presented with acute myocardial infarction in different seasons.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2023
- Study start1 Jun 2023 (estimated)
- Primary completion1 Feb 2024 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fady Nabil Israiel Moughiura, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05788640
- Sponsor's protocol ID
- MI in seasonal variation
- Status last verified
- Mar 2023
- First submitted
- 29 Jan 2023
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Nagarajan V, Fonarow GC, Ju C, Pencina M, Laskey WK, Maddox TM, Hernandez A, Bhatt DL. Seasonal and circadian variations of acute myocardial infarction: Findings from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program. Am Heart J. 2017 Jul;189:85-93. doi: 10.1016/j.ahj.2017.04.002. Epub 2017 Apr 12.
PubMed 28625385Thosar SS, Butler MP, Shea SA. Role of the circadian system in cardiovascular disease. J Clin Invest. 2018 Jun 1;128(6):2157-2167. doi: 10.1172/JCI80590. Epub 2018 Jun 1.
PubMed 29856365
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Circadian and Seasonal Variation in Acute Myocardial Infarction in Relation to Blood Viscosity and Outcome Among Adults Attending the Main Assiut University Hospital
- ClinicalTrials.gov ID
- NCT05788640
- Acronym / sponsor ID
- MI in seasonal variation
- Conditions
- Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (estimated)
- Primary completion
- 1 Feb 2024 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 29 Mar 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.
Circadian and seasonal variation in acute myocardial infarction .
Detailed description
Circadian and seasonal variation in acute myocardial infarction and relation between circadian rhythm and seasonal variations with biological and physiological markes of normal human being.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Sample size was calculated using Epi- Info7. Expected frequency of cardiac onset is 15%. Based on this frequency and with a confidence limits of 6% and a confidence level of 90%, the sample needed for the study was estimated to be about from 138 patients and 196 at 95% CI .The sample will be calculated in the seasons of extreme seasonal changes at 2023, 2024
Key inclusion criteria (1 listed)
- 1.All patients above (16) years old 2.Complaint occur during acute climate changes
Key exclusion criteria (1 listed)
- 1.Patients below 16 years old 2.Complaint during normal climate
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Circadian and seasonal variation in acute myocardial infarction
Time frame: Baseline
Reporting the presence or absence of difference in electrocardiogram ,Echo and d-Dimer between patients presented with acute myocardial infarction in different seasons.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Mar 2023.
- Background: PubMed 28625385Nagarajan V, Fonarow GC, Ju C, Pencina M, Laskey WK, Maddox TM, Hernandez A, Bhatt DL. Seasonal and circadian variations of acute myocardial infarction: Findings from the Get With The Guidelines-Coronary Artery Disease (GWTG-CAD) program. Am Heart J. 2017 Jul;189:85-93. doi: 10.1016/j.ahj.2017.04.002. Epub 2017 Apr 12.
- Background: PubMed 29856365Thosar SS, Butler MP, Shea SA. Role of the circadian system in cardiovascular disease. J Clin Invest. 2018 Jun 1;128(6):2157-2167. doi: 10.1172/JCI80590. Epub 2018 Jun 1.
- Individual participant dataSharing planned: No
Related trials for Myocardial Infarction
Not yet recruitingPhase 4
Roxadustat and Myocardial Injury After Off-Pump Coronary Artery Bypass Surgery
Coronary Artery Disease, Coronary Artery Bypass Grafting
Active, not recruitingObservational study
A Longitudinal Cohort Study to Evaluate Cardiovascular Risk Factors and Disease in Haiti
Hypertension, Diabetes
Active, not recruitingPhase 3
A Study of Inclisiran to Prevent Cardiovascular Events in High-risk Primary Prevention Patients.
Primary Prevention of Atherosclerotic Cardiovascular Disease
Enrolling by invitation
The DANE-HEART Trial - Computed Tomography Coronary Angiography for Primary Prevention
Coronary Atherosclerosis and Other Heart Disease, Cardiovascular Diseases
Not yet recruitingObservational study
Elicit Drugs in Myocardial Infarction
Young Patients With Acute Myocardial Infarction
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.
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 Assiut 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 1 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 29 Mar 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fady Nabil, Resident (01271790912, Fadynabil7777@gamil.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Circadian and seasonal variation in acute myocardial infarction (time frame: Baseline). 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 NCT05788640, which also lists 2 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 29 Mar 2023.