NCT05125419

Brief Summary

This study aims to determine the relation between high homocysteine levels and increased incidence of acute coronary syndrome in young patients

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2021

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

November 6, 2021

Completed
12 days until next milestone

First Posted

Study publicly available on registry

November 18, 2021

Completed
12 days until next milestone

Study Start

First participant enrolled

November 30, 2021

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 30, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2023

Completed
Last Updated

July 6, 2023

Status Verified

July 1, 2023

Enrollment Period

1.5 years

First QC Date

November 6, 2021

Last Update Submit

July 4, 2023

Conditions

Acute Coronary Syndrome

Outcome Measures

Primary Outcomes (1)

  • Coronary care unit admission with acute coronary syndrome

    Acute coronary syndrome hospitalization and cardiovascular deathes and estimated hazard ratios (HR) by use of multivariable Cox regression models

    From date of randomization up to 1 month

Interventions

Homocysteine levelDIAGNOSTIC_TEST

diagnostic test

Also known as: HCY

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients presented with acute coronary syndrome admitted to coronary care unit of Sohag University hospital according to inclusion and exclusion criteria

You may qualify if:

  • \- The patients who presented in the hospital with chest pain consistent with acute coronary syndrome with any of the following features:
  • Electrocardiogram (ECG) changes:
  • ST elevation
  • ST depression
  • T wave inversion
  • recent left bundle branch block
  • Troponin T elevation (Norma value \< 0.06)
  • Age: -Between 18- 40 years (Group A) - Age \> 40 years (Group B)

You may not qualify if:

  • Chest pain not consistent with acute coronary syndrome
  • Chronic kidney disease (CKD)
  • Rheumatic heart disease (RHD)
  • Congenital heart disease
  • Anemia
  • Cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University

Sohag, Egypt

Location

Related Publications (1)

  • Liu J, Quan J, Li Y, Wu Y, Yang L. Blood homocysteine levels could predict major adverse cardiac events in patients with acute coronary syndrome: A STROBE-compliant observational study. Medicine (Baltimore). 2018 Oct;97(40):e12626. doi: 10.1097/MD.0000000000012626.

    PMID: 30290636BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Study Officials

  • Mohammed E Amin, Lecturer

    Sohag University

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
CROSS SECTIONAL
Target Duration
6 Months
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

November 6, 2021

First Posted

November 18, 2021

Study Start

November 30, 2021

Primary Completion

May 30, 2023

Study Completion

July 1, 2023

Last Updated

July 6, 2023

Record last verified: 2023-07

Locations

EG(1)