NCT03830138

Brief Summary

Coronary artery disease (CAD) is increasing rapidly in Egyptian people and manifesting a younger age. Higher plasma low-density lipoprotein cholesterol (LDL-C), is a major predictor for the development of CAD. However, whether oxidized-LDL (ox-LDL) can be used as a risk factor for myocardial infarction (MI) has not been fully investigated. Therefore, the aim of the present study was to examine the role of ox-LDL as a risk factor for the presence and clinical outcomes in patients with MI.

Trial Health

35
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Shorter than P25 for all trials

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

February 1, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

February 5, 2019

Completed
15 days until next milestone

Study Start

First participant enrolled

February 20, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2019

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

February 5, 2019

Status Verified

February 1, 2019

Enrollment Period

1 month

First QC Date

February 1, 2019

Last Update Submit

February 4, 2019

Conditions

Acute Coronary Syndrome

Keywords

Oxidized-LDLOLR1 geneSingle nucleotide polymorphismOxygen therapy

Outcome Measures

Primary Outcomes (1)

  • The mean difference of oxidized-LDL gene polymorphism between patients and controls

    The mean difference of oxidized-LDL gene polymorphism will be assessed by RFLP. The change of single nucleotide polymorphism of oxidized-LDL from healthy controls at baseline

    Baseline

Study Arms (2)

Acute coronary syndrome patients:

One hundred patients with acute coronary syndrome.

Genetic: Oxidized-LDL gene polymorphism

Controls:

Fifty healthy control

Genetic: Oxidized-LDL gene polymorphism

Interventions

Oxidized-LDL gene polymorphismGENETIC

Oxidized-LDL gene polymorphism will be measured by RFLP. In addition, Oxidized-LDL will be measured in the plasma by ELISA

Acute coronary syndrome patients:Controls:

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Acute coronary syndrome patients

You may qualify if:

  • Patients were included irrespective of concomitant risk factors for atherosclerosis such as smoking, arterial hypertension and diabetes mellitus.
  • Participants were both sexes.

You may not qualify if:

  • Congenital heart disease.
  • Dilated, hypertrophic or restrictive cardiomyopathy.
  • acute and chronic liver disorders.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (4)

  • Ehara S, Ueda M, Naruko T, Haze K, Itoh A, Otsuka M, Komatsu R, Matsuo T, Itabe H, Takano T, Tsukamoto Y, Yoshiyama M, Takeuchi K, Yoshikawa J, Becker AE. Elevated levels of oxidized low density lipoprotein show a positive relationship with the severity of acute coronary syndromes. Circulation. 2001 Apr 17;103(15):1955-60. doi: 10.1161/01.cir.103.15.1955.

    PMID: 11306523BACKGROUND

  • Trabetti E, Biscuola M, Cavallari U, Malerba G, Girelli D, Olivieri O, Martinelli N, Corrocher R, Pignatti PF. On the association of the oxidised LDL receptor 1 (OLR1) gene in patients with acute myocardial infarction or coronary artery disease. Eur J Hum Genet. 2006 Jan;14(1):127-30. doi: 10.1038/sj.ejhg.5201513.

    PMID: 16251892BACKGROUND

  • Zhao X, Zhang HW, Xu RX, Guo YL, Zhu CG, Wu NQ, Gao Y, Li JJ. Oxidized-LDL is a useful marker for predicting the very early coronary artery disease and cardiovascular outcomes. Per Med. 2018 Nov;15(6):521-529. doi: 10.2217/pme-2018-0046. Epub 2018 Oct 26.

    PMID: 30362886BACKGROUND

  • Raut MS, Maheshwari A. Oxygen supplementation in acute myocardial infarction: To be or not to be? Ann Card Anaesth. 2016 Apr-Jun;19(2):342-4. doi: 10.4103/0971-9784.179594. No abstract available.

    PMID: 27052081BACKGROUND

MeSH Terms

Conditions

Acute Coronary Syndrome

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular Diseases

Central Study Contacts

reham elmahdy

CONTACT

+201002714637reham.elmahdy@aun.edu.eg

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 1, 2019

First Posted

February 5, 2019

Study Start

February 20, 2019

Primary Completion

April 1, 2019

Study Completion

May 1, 2019

Last Updated

February 5, 2019

Record last verified: 2019-02