Cardiac Biomarkers in Preeclampsia: Prediction of Disease and the Risk of Future Cardiovascular Events in Survivors
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 263
- 试验地点
- 1
- 主要终点
- Serum levels of cardiac biomarkers
研究概览
简要总结
SUMMARY Background: Improvements in the management and prevention of obstetric haemorrhage and sepsis, in addition to magnesium sulphate for preeclampsia have led to significant reduction in global maternal mortality rates; thus leaving increasing number of survivors of preeclampsia than previously. Preeclampsia is associated with inflammatory changes that alter vascular integrity - an effect which may persist beyond pregnancy, resulting in atherosclerosis which predisposes to myocardial ischemia, myocardial infarction and stroke.
Aim: To predict preeclampsia early in pregnancy and detect preeclampsia survivors at risk for future cardiovascular disease and events using cardiac and gene markers.
Methods: a cohort study design with recruitment of participants at 3 stages; in the first trimester of pregnancy, second half and the puerperium. Serum levels of fibrinogen, hsCRP, apoA/apoB, triglycerides and other lipids, in addition to genetic studies would be compared between those with preeclampsia and normal pregnancies, delivered mothers would be followed up from puerperium, upto 5 years.
Data Analysis: would be performed using the Statistical Package for Social Sciences (SPSS) software version 21.0. Numerical data would be expressed as mean ± standard deviation (SD). Results from the two groups of women would be compared using the independent T-test, Analysis of Variance (ANOVA) and the chi-square test while the Mantel Haenszel statistics would be used to determine risks. The level of statistical significance would be set at p-value less than 0.05.
Conclusion: Myocardial ischemia, myocardial infarction and stroke are major causes of sudden death because their precursors; atherosclerosis and hypertension are asymptomatic. Under-utilization of routine health care check further increases the risk of sudden death from these conditions. Preeclampsia is a recognized risk factor and screening of survivors would help to detect women at risk for cardiovascular diseases and offer early preventive care.
详细描述
Preeclampsia is a disease that is strongly linked with the risk of stroke and other cardiovascular disease. This is a condition with greater prevalence in the Low and middle income countries of the world especially sub-Saharan Africa, where the morbidity and mortality is reportedly higher. Larger numbers of survivors are expected with the rising global gains in maternal mortality reduction associated with preeclampsia. These cardiovascular diseases myocardial ischemia, myocardial infarction and stroke are major causes of sudden death because the precursor conditions; atherosclerosis and hypertension are largely asymptomatic. There are established biomarkers for these conditions which can be used as screening tools. The low utilization of routine health care check and the asymptomatic nature of these events increase the risk of sudden premature death from these conditions. The postnatal period offers a good opportunity for screening for these events to detect women at risk and offer early preventive care.
Preeclampsia is essentially a disease of the trophoblast, it has also been shown to be associated with oxidative stress, a phenomenon, which increases the levels of LDL cholesterol peroxidation, leading to its increased uptake by macrophages, resulting in foam cell formation and atherosclerosis. Preeclampsia is also associated with inflammatory changes that alter vascular integrity - an effect which may persist beyond pregnancy, resulting in atherosclerosis which predisposes to myocardial ischemia, myocardial infarction and stroke.
These changes in the vasculature are asymptomatic and unless hypertension is detected early and vasoprotective or antithrombotic treatment commenced, sudden death may occur from stroke or acute myocardial infarction.
Hypertensive heart disease refers to heart conditions that result from the effect of hypertension. The heart in this instance now works under a higher pressure resulting in the hypertrophy of cardiac muscle, thickening of the cardiac arterial vasculature (leading to coronary arterial disease) and increased risk of myocardial ischemia and infarction. The resulting cardiac muscle dysfunction leads to increasing levels of pro-inflammatory cytokines, which can be detected in the blood stream and whose levels may correlate with the presence and severity of the disease condition. Hypertension has similar effects on the cerebral vasculature, where it can cause vessel rupture resulting in life-threatening intracranial haemorrhage. The vessels under the influence of long standing hypertension may undergo hypertrophy leading to thickening of the vessel wall with narrowing of lumen and then cerebral ischemia, infarction and stroke.
There is a significant reduction in the risk of fatal and non-fatal stroke if hypertension is detected early and effectively controlled with antihypertensive drugs. This preventive strategy has been shown to be of more benefit when commenced at a younger age and especially in women of the black race who are at higher risk and would benefit more.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 45 Years(Adult)
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy pregnant women at gestational age less than 20 weeks
- •Women with diagnosis of preeclampsia at gestational age 20-41 weeks
- •Healthy pregnant women without preeclampsia at gestational age 20-41 weeks
- •Women less than one year postpartum with history of preeclampsia or eclampsia in index pregnancy
- •Healthy women less than 1 year postpartum with no previous history of preeclampsia or eclampsia
排除标准
- •History of chronic hypertension or hypertension before pregnancy
- •Patients with cardiac disease
- •Patients with renal disease
- •Patients with diabetes mellitus
- •Patients with connective tissue disorders
结局指标
主要结局
Serum levels of cardiac biomarkers
时间窗: Baseline
Serum concentrations of hsCRP, fibrinogen, apoB, lipid profile in mg/dL
次要结局
- Development of cardiovascular events(Year 1, Year 2 and Year 5)
