NCT04243876

Brief Summary

Myocardial infarction is a polygenic disease that may occur due to various environmental risk factors. Mortality risk of the disease; sex, age, smoking, systolic blood pressure, total cholesterol, and high-density lipoprotein levels. The paraoxonase-1 phenotype is expressed as the paraoxonase/arylesterase ratio and is closely related to high-density lipoprotein, acting as an endogenous defense mechanism against vascular oxidative stress, thus contributing to the prevention of atherosclerosis. Serum concentration and activity depend on environmental factors as well as genetic polymorphism. This decrease in enzyme concentration causes changes in gene expression (1). Numerous data on Paraoxonase-1 levels have been found in studies, especially with decreasing serum paraoxonase and arylesterase activities with age, associated with increased risk of systemic oxidative stress and atherosclerosis in humans. Many studies have shown that serum Paraoxonase-1 activity is significantly reduced in people with myocardial infarction, dyslipidemia, atherosclerosis, and chronic kidney disease. The most important risk factor for these and similar diseases is aging. Diversity of conditions such as genetic predisposition, malnutrition, stress, and smoking, which increases vascular dysfunction due to oxidative stress, classify individuals with acute myocardial infarction according to age groups and investigate whether there is a relationship between serum Paraoxonase-1 activity and severity of coronary artery disease in young patients. The paraoxonase-1 enzyme, which is known to decrease blood levels with age, is found to be significantly lower in patients with myocardial infarction at a young age compared to the healthy control group.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2019

Typical duration 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

Study Start

First participant enrolled

December 30, 2019

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

December 31, 2019

Completed
28 days until next milestone

First Posted

Study publicly available on registry

January 28, 2020

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 27, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 27, 2022

Completed
Last Updated

May 31, 2022

Status Verified

May 1, 2022

Enrollment Period

2.4 years

First QC Date

December 31, 2019

Last Update Submit

May 27, 2022

Conditions

Keywords

Myocardial infarction, Paraoxonase

Outcome Measures

Primary Outcomes (1)

  • early diagnosis

    paraoxonase enzyme measurement

    one year

Study Arms (2)

paraoxanase

Enzyme level

Diagnostic Test: paraoxanase enzyme level

Myocardial infarction

RESULTS OF ANGIOGRAPHY

Diagnostic Test: paraoxanase enzyme level

Interventions

presence of paraoxonase enzyme deficiency and associated troponin elevation

Also known as: troponin level, HDL level
Myocardial infarctionparaoxanase

Eligibility Criteria

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

All patients admitted to the emergency department over the age of 18

You may qualify if:

  • Those over the age of 18
  • All acute coronary syndrome patients

You may not qualify if:

  • \- Patients with normal angiography

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bezmialem vakif university

Istanbul, Eyalet/Yerleşke, 34093, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Myocardial InfarctionHypoalphalipoproteinemias

Condition Hierarchy (Ancestors)

Myocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosisHypolipoproteinemiasLipid Metabolism, Inborn ErrorsMetabolism, Inborn ErrorsGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesDyslipidemiasLipid Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • bahadir taslidere

    BEZMİALEM VAKİF UNİVERSİTY

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor, clinical research

Study Record Dates

First Submitted

December 31, 2019

First Posted

January 28, 2020

Study Start

December 30, 2019

Primary Completion

May 27, 2022

Study Completion

May 27, 2022

Last Updated

May 31, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

nope

Locations