NCT06343844招募中不适用
Disparities in Myocardial Infarction Remodeling According to Gender
University Hospital, Angers1 个研究点 分布在 1 个国家目标入组 1,650 人开始时间: 2024年7月15日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 1,650
- 试验地点
- 1
- 主要终点
- Asses left ventricular remodeling disparities between genders
研究概览
简要总结
Following myocardial infarction, female individuals demonstrate a poorer prognosis, characterized by elevated rates of mortality and heart failure. A primary hypothesis suggests unfavorable cardiac remodeling in women. This remodeling, defined as alterations in cardiac size and shape post-infarction, necessitates repeated non-invasive imaging for study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •First myocardial infarction with ST-segment elevation during the hospital phase
- •Coronary angiography performed within 72 hours of the infarction
- •Inclusion in the RIMA registry
- •Patient affiliated or beneficiary of a social security scheme; Signature of informed consent
排除标准
- •Patients already enrolled in the study
- •Poor understanding of the French language
- •Pregnant, breastfeeding, or postpartum women
- •Individuals deprived of liberty by judicial or administrative decision; Individuals receiving psychiatric care under coercion
- •Individuals subject to a legal protection measure; Individuals incapable of giving consent
研究组 & 干预措施
case control registry
Other
left ventricular remodeling measurement with cardiac echography
干预措施: cardiac imaging to assess left ventricular volumes and function (Diagnostic Test)
结局指标
主要结局
Asses left ventricular remodeling disparities between genders
时间窗: baseline; 3 months and 1 year after myocardial infarction onset
The primary outcome measure will be the occurrence of left ventricular remodeling (defined as a change in ventricular volume of more than 10% during follow-up) measured with cardiac imaging (echocardiography and MRI)
次要结局
- Evaluate the evolution of remodeling at Month 3(3 months)
- Assess remodeling changes between inclusion and Month 12(1 year)
- Explore prognostic disparities between men and women.(yearly, up to 10 years)
- Evaluate lifestyle habits up to 10 years: outcome physical activity(yearly, up to 10 years)
- Assess the risk of remodeling based on specific parameters in female subjects: presence of endometriosis(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: presence of polycystic ovary(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: presence of uterine fibroma(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: presence of hormonal therapy(baseline)
- Assess the prevalence of comorbidities and their impact on the effect on the outcome: post-infarction cardiac remodeling with gender (cardiovascular risk factors, renal function, hepatic functionperipheral artery disease, way of life)(3 months and 1 year)
- Evaluate lifestyle habits up to 10 years: outcome diet score(yearly, up to 10 years)
- Evaluate lifestyle habits up to 10 years: outcome anxiety/depression(yearly, up to 10 years)
- Assess the risk of remodeling based on specific parameters in female subjects: date of first period(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: pregnancy(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: children(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: obstetrical event(baseline)
- Assess the risk of remodeling based on specific parameters in female subjects: menopause(baseline)
研究者
研究点 (1)
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