NCT05692752

Brief 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. 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).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2022

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

December 22, 2022

Completed
6 days until next milestone

Study Start

First participant enrolled

December 28, 2022

Completed
13 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 10, 2023

Completed
4 days until next milestone

Study Completion

Last participant's last visit for all outcomes

January 14, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

January 20, 2023

Completed
Last Updated

January 20, 2023

Status Verified

January 1, 2023

Enrollment Period

13 days

First QC Date

December 22, 2022

Last Update Submit

January 18, 2023

Conditions

Myocardial Infarction, Acute

Outcome Measures

Primary Outcomes (10)

  • Expression of miR-133a

    Expression during episodes of myocardial infarction

    04 hours from the onset of the infarct

  • Expression of miR-133a

    Expression during episodes of myocardial infarction

    08 hours from the onset of the infarct

  • Expression of miR-133a

    Expression during episodes of myocardial infarction

    12 hours from the onset of the infarct

  • Expression of miR-133a

    Expression during episodes of myocardial infarction

    24 hours from the onset of the infarct

  • Expression of miR-133a

    Expression during episodes of myocardial infarction

    48 hours from the onset of the infarct

  • Expression of miR-208b

    Expression during episodes of myocardial infarction

    04 hours from the onset of the infarct

  • Expression of miR-208b

    Expression during episodes of myocardial infarction

    08 hours from the onset of the infarct

  • Expression of miR-208b

    Expression during episodes of myocardial infarction

    12 hours from the onset of the infarct

  • Expression of miR-208b

    Expression during episodes of myocardial infarction

    24 hours from the onset of the infarct

  • Expression of miR-208b

    Expression during episodes of myocardial infarction

    48 hours from the onset of the infarct

Study Arms (2)

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)

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,

Other: No intervention

Interventions

No interventionOTHER

Expression of miR-133a \&208b at 4, 8, 12, 24 and 48 hours from the first appearance of myocardial infarction (MI) symptoms

Also known as: Expression of miR-133a & 208b
Control GroupTest Group

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patient registering at the Coronary Care Unit at Ain-shams University hospital German University in Cairo, New Cairo City,.Egypt

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Biochemistry Department, Faculty of Pharmacy and Biotechnology, German University in Cairo, Main Entrance Al Tagamoa Al Khames

Cairo, 11835, Egypt

Location

MeSH Terms

Conditions

Myocardial Infarction

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Sally I Hassanien, Ph.D

    Biochemistry Department German University in Cairo, 11835, Cairo, Egypt

    PRINCIPAL INVESTIGATOR

  • Hafiz A Sattar, M.Phil

    University College of Conventional Medicine, The Islamia University of Bahawalpur, Punjab, Pakistan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Target Duration
3 Days
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Lecturer

Study Record Dates

First Submitted

December 22, 2022

First Posted

January 20, 2023

Study Start

December 28, 2022

Primary Completion

January 10, 2023

Study Completion

January 14, 2023

Last Updated

January 20, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

De-identified data will be published.

Locations

EG(1)