NCT05788640

Brief Summary

Circadian and seasonal variation in acute myocardial infarction .

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 29, 2023

Completed
2 months until next milestone

First Posted

Study publicly available on registry

March 29, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

June 1, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2026

Completed
Last Updated

March 29, 2023

Status Verified

March 1, 2023

Enrollment Period

8 months

First QC Date

January 29, 2023

Last Update Submit

March 27, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Eligibility Criteria

Age16 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • All patients above (16) years old 2.Complaint occur during acute climate changes

You may not qualify if:

  • Patients below 16 years old 2.Complaint during normal climate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University

Asyut, Egypt

Location

Related Publications (2)

  • 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.

    PMID: 28625385BACKGROUND
  • 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.

    PMID: 29856365BACKGROUND

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Central Study Contacts

Fady Nabil, Resident

CONTACT

Hanaan Sharaf, Prof

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Resident doctor of critical care internal medicine

Study Record Dates

First Submitted

January 29, 2023

First Posted

March 29, 2023

Study Start

June 1, 2023

Primary Completion

February 1, 2024

Study Completion

February 1, 2026

Last Updated

March 29, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations