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临床试验/NCT06675890
NCT06675890已完成不适用

Correlation of Serum Homocysteine Levels With Various Types of Coronary Artery Disease (CAD) and In-hospital Mortality

Shaqra University1 个研究点 分布在 1 个国家目标入组 381 人开始时间: 2022年3月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
381
试验地点
1
主要终点
Homocysteine levels and its correlation with the type of coronary artery disease.

研究概览

简要总结

This study is aimed at correlating serum homocysteine level with coronary artery disease (CAD) and related in-hospital mortality. A cross section of patients from age 18 years and above will be studied for homocysteine level and analyzed for the above mentioned correlation. The study was approved by hospital ethical review board as mentioned. An informed written consent was obtained before the patients' recruitment.

详细描述

This study explores the correlation between serum homocysteine levels, coronary artery disease (CAD), and in-hospital mortality, addressing the need to understand homocysteine's role as a potential marker for CAD severity and mortality risk. Homocysteine is an amino acid linked to vascular inflammation and endothelial damage, both critical factors in cardiovascular pathology. Elevated homocysteine levels, often stemming from genetic predispositions or lifestyle factors like poor diet and smoking, are associated with endothelial dysfunction, plaque formation, and thrombotic complications, all of which are common in CAD patients. Thus, investigating this correlation is essential, as it may reveal whether homocysteine levels can reliably predict CAD outcomes or mortality risk in hospitalized patients, potentially impacting future diagnostic and therapeutic protocols.

Study Design and Methodology The study adopts a cross-sectional design to assess patients aged 18 years and older, utilizing serum homocysteine level testing and correlational analyses with CAD severity and mortality outcomes. A cross-sectional study is particularly suitable for identifying associations and trends within a specific population at a single point in time, making it advantageous for examining homocysteine's role in CAD. The study captures a broad spectrum of CAD presentations and risk profiles by including adult patients from various backgrounds. This allows for a more comprehensive analysis of homocysteine levels in various CAD contexts, from mild cases to severe in-hospital mortalities.

The study's inclusion of patients above 18 years ensures a diverse age demographic, crucial for understanding homocysteine's role in different age-related presentations of CAD. It allows for subgroup analyses to observe how age may influence homocysteine's effects on CAD progression or outcomes, as younger and older patients may exhibit differing metabolic and vascular responses. Homocysteine levels are influenced by various physiological, lifestyle, and genetic factors, which can vary across age groups. Observing these distinctions can add depth to our understanding of CAD in relation to homocysteine.

Ethical Considerations and Consent The ethical framework of this study is paramount, especially in a hospital setting with vulnerable patients. Approval from the hospital's ethical review board underpins the study's commitment to ethical standards, ensuring that the research adheres to principles such as patient confidentiality, respect, and transparency. Ethical board approval also reflects adherence to institutional standards for patient welfare and safety. Participants were informed of the study's objectives, procedures, and potential implications, allowing them to make an informed decision about participation. Written informed consent ensures patients voluntarily agree to partake, providing them with an understanding of their participation and rights as subjects.

Informed consent also means participants understand that their serum homocysteine levels will be evaluated alongside their CAD diagnosis and outcomes, making them aware of potential benefits and risks. The consent process ensures voluntary participation, empowering patients and fostering trust. As part of ethical considerations, the study includes provisions for confidentiality, ensuring patients' data is used only for research purposes and stored securely to protect personal health information.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

入排标准

年龄范围
25 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Coronary artery disease patients from age 25 years to 80 years.

排除标准

  • Grade 4 chronic kidney disease patients
  • Chronic liver disease patients
  • Pregnant and lactating females
  • Patients on vitamin supplements
  • Patients with genetic homocysteine abnormalities

结局指标

主要结局

Homocysteine levels and its correlation with the type of coronary artery disease.

时间窗: 2 years

Higher homocysteine levels in ST segment myocardial infarction (STEMI) and non ST segment myocardial infarction (NSTEMI) as compared to Angina.

次要结局

  • Risk factors for coronary artery disease(2 years)

研究者

发起方
Shaqra University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Himayat Ullah

Assistant Professor/Dr

Shaqra University

研究点 (1)

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