Prospective Registry in Young Women Presenting Acute Myocardial Infarction in France: Clinical, Morphological and Biological Descriptive Analysis: WAMIF Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 324
- 试验地点
- 57
- 主要终点
- the combined endpoint of major cardiovascular events
研究概览
简要总结
MI in elderly women seems to share the same pathophysiology than in men, especially plaque rupture associated with conventional risk factors. Therefore the questions is not solved on the pathophysiology and specific risk factors in young women whose prognosis is more severe. A complete descriptive analysis appears mandatory to understand the peculiarities, including not only morphological but also biological explorations as well.
To date no systematic descriptive analysis has been performed including clinical characteristics, cardiac and extra-cardiac morphological exploration and hormonal and immunological assays, particularly in young premenopausal women presenting MI.
This study will provide for the first time a complete analysis, including hormonal assays, never made in an "acute" population.
The main objective of this clinical study is to systematically pool clinical, morphological and biological data of young women (< 50 years) presenting an Acute MI and to assess their short-term (in-hospital) and mid-term (12 months) prognosis. The definition of MI is the one adopted in the Third definition published in 2012. As such an event occurs in a young patient, diagnostic and treatment may vary among centres. The incidence of such cases in each centre being low and practice inhomogeneous, no conclusion could be advanced concerning the study of associated, indeed predisposing factors.
The work aims to comprehensively and systematically collect all the clinical and laboratory data and the results of the all morphological explorations carried out during the care of these young women admitted for acute MI in high-volume centres.
No additional invasive act, without any direct benefit for the care of patients will be realized for research purposes.
All these examinations, in particular invasive morphological, are more and more integrated in the practice of modern interventional cardiology especially for complex or infrequent situations, like this setting. They afford accurate diagnosis of coronary disease on one hand and on the second hand they determine the causal or at least participating factor.
A comprehensive and systematic analysis of this particular entity that is MI in young woman, would improve our knowledge of this disease and then enable to offer patients a more appropriate treatment and monitoring. It is necessary to progress in the understanding of the mechanisms of the early onset of coronary artery disease in its most acute and most serious presentation and to clearly define the specificities of coronary disease in young women. Moreover, a more precise identification of risk factors of MI in a woman under 50 will allow a better screening and even introduction of preventive strategies.
详细描述
Cardiovascular disease is the leading cause of death among women in France. In-hospital mortality after acute coronary syndrome (ACS) remains significantly higher than in men, with a relative risk of up to 150%, especially among young women1,2. Early mortality rate of myocardial infarction (MI) continues to decline but that of women remains higher.
Background The risk of ACS increases with age, especially after menopause and in the presence of classic cardiovascular risk factors such as hypertension or diabetes. Nevertheless premenopausal women presenting MI are not exceptional even in the absence of risk factors. The worse prognosis in women, particularly in individuals under 50 years could result from the combination of harsher clinical presentation, less typical symptoms, and delayed diagnosis. Moreover, it is not uncommon that an ACS occurs in young women without the usual risk factors. Hormonal changes in particular related to contraceptive treatments have been incriminated, likewise chronic inflammation related to systemic diseases. To date the impact of hormonal, inflammatory or thrombophilia changes has not been elucidated.
Nowadays use of endovascular imaging during diagnostic coronary angiography is become common practice in particular in the absence of obvious culprit thrombotic or obstructive lesion. These invasive imaging techniques such as intravascular ultrasound (IVUS) or OCT (Optical Coherence Tomography), bring highly relevant complementary information in this setting, particularly to clarify the mechanism of MI such as rupture or erosion of atherosclerotic plaque, spontaneous dissection or intramural hematoma. The incidence of these particular form of acute coronary artery lesions are higher in women, especially among the youngest one.
In young, an angioCT or angioMRI (aortic and/or cerebral) are often performed looking for other atherosclerotic risk locations or morphological abnormalities in favour of a particular disease such as a fibrodysplasia. PET scan (18FDGlusose scintigraphy), when available, provides a valuable complement: it is a functional imaging research for other arterial locations for hypermetabolic inflammatory arteritis.
Usual laboratory tests will be made at admission and discharge as done in routine practice. These tests include blood count, electrolytes, blood urea, creatinine, prothrombin time, activated partial thromboplastin time, glucose, HbA1C, lipide profil, hemoglobin electrophoresis, CRP, fibrinogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women over 18 and under 50 years of age
- •Women admitted for MI defined by significant release of biological markers of myocardial necrosis associated with one of the following signs: chest pain and / or ECG abnormalities and / or loss of viable myocardium in imaging and / or thrombus to coronary angiography
- •Coronary angiography performed
- •Patient not objecting to the use of personal data.
- •Beneficiary of a social protection (excluding AME)
- •Signature of informed consentement form
排除标准
- •Iatrogenic MI and those of patients who died before hospitalization
- •Other causes of chest pain syndrome with elevated troponin, including myocarditis, Tako Tsubo, sepsis will be excluded after performing an MRI.
- •Participation in other biomedical research protocol excluding registers
- •Linguistic or mental disability or refusal to sign the informed consent
结局指标
主要结局
the combined endpoint of major cardiovascular events
时间窗: From date of randomization until the date of first documented date of death from any cause, cardiovascular death, recurrent MI, stent thrombosis, stroke and major bleeding, whichever came first, assessed up to discharge of the patient
The primary endpoint will be the combined endpoint of major cardiovascular events occurring during the index hospitalization: death from any cause, cardiovascular death, recurrent MI, stent thrombosis, stroke and major bleeding (defined as classified BARC 3 to 5).
次要结局
- prevalence of classical cardiovascular risk factors(through study completion, an average of 1 year)
- Presence or absence of a higher prevalence of diseases related to inflammation or thrombophilia(through study completion, an average of 1 year)
- Frequency of the rare non atheromatous(through study completion, an average of 1 year)
- Influence of gynaecological and obstetrical status, hormonal parameters, and in particular hormonal profiles at risk: SHBG elevation(through study completion, an average of 1 year)
- Anatomical characteristics of culprit lesions(from date of enrollment up to 12 months)
- Number of extracardiac events(through study completion, an average of 1 year)
- Prevalence of systemic diseases in this population,(through study completion, an average of 1 year)
- Major cardiovascular events at 12 months after(through study completion, an average of 1 year)
- Prevalence of heredity(through study completion, an average of 1 year)