- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05788640
Circadian and Seasonal Variation in Acute Myocardial Infarction
March 27, 2023 updated by: Fady Nabil Israiel Moughiura, Assiut University
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 .
Study Overview
Status
Not yet recruiting
Conditions
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 Type
Observational
Enrollment (Anticipated)
100
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: Fady Nabil, Resident
- Phone Number: 01271790912
- Email: Fadynabil7777@gamil.com
Study Contact Backup
- Name: Hanaan Sharaf, Prof
- Phone Number: 01005035006
- Email: Dr_Hanansharaf@yahoo.com
Study Locations
-
-
-
Assiut, Egypt
- Assiut University
-
Contact:
- Hanaan Sharaf, Prof
- Phone Number: 01005035006
- Email: Dr_Hanansharaf@yahoo.com
-
Contact:
- Fady Nabil, Resident
- Phone Number: 01271790912
- Email: Fadynabil7777@gmail.com
-
-
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
16 years to 75 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
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
Description
Inclusion Criteria:
- 1.All patients above (16) years old 2.Complaint occur during acute climate changes
Exclusion Criteria:
- 1.Patients below 16 years old 2.Complaint during normal climate
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
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
Baseline
|
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
- 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.
- Thosar 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.
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)
June 1, 2023
Primary Completion (Anticipated)
February 1, 2024
Study Completion (Anticipated)
February 1, 2026
Study Registration Dates
First Submitted
January 29, 2023
First Submitted That Met QC Criteria
March 27, 2023
First Posted (Actual)
March 29, 2023
Study Record Updates
Last Update Posted (Actual)
March 29, 2023
Last Update Submitted That Met QC Criteria
March 27, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MI in seasonal variation
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
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.