CARIM Cohort (CARdioprotection in Myocardial Infarction)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 2,000
- 试验地点
- 2
- 主要终点
- Determinants of myocardial infarct injury
研究概览
简要总结
CARIM is a prospective cohort of 2,000 patients with a first myocardial infarction and undergoing reperfusion therapy. Therefore, male and female patients older than 18 years and younger than 90 years with onset of chest pain of less than 12 hours who need a primary percutaneous coronary intervention (PCI) for a ST elevation segment MI (STEMI) will be recruited.
详细描述
In the setting of research in ischemic cardiomyopathy, the CARIM cohort aims to meet the expectation and strategy of Aviesan (Alliance nationale pour les sciences de la VIE et de la SANté) since it will address the underlying pathophysiology of the determinants of MI injury and its impact on follow-up, in addition with the potential confounding clinical and biological factors. Therefore, CARIM cohort will offer a great opportunity of describing the interactions between myocardial infarction and surrounding environment (clinical, social and professional). This cohort will use complementary state of the art approaches (cardiac imaging including Cardiovascular Magnetic Resonance and echocardiography, biomarkers, proteomic, genetic and pharmacogenetics) with strong interactions between the different partners. Therefore CARIM cohort should help to obtain a modeling of the determinants of the MI size.
The investigators expect that CARIM cohort will provide new imaging or biological markers that may bring early information regarding the severity of lethal reperfusion injury.
By optimizing the knowledge on infarct injury in addition with a 5-year clinical and echographic follow-up, this cohort will better stratify the prognosis after MI and will therefore give new insights in identifying patients at higher risk of left ventricular remodeling and subsequent heart failure. It will therefore help and emphasize prevention messages and patients' education. The aim is to translate this information directly into patient care by using the science generated by this project to develop new management guidelines and novel clinical tools (confounder-annotated database, imaging and biological biomarkers). This cohort may have additional impact in patient care by adapting the treatment to patient-related confounders (age, diabetes...), genetic polymorphisms and thus personalizing health care to individuals.
3.2 MAIN OBJECTIVE
The investigators main objective is to create a prospective cohort of 2,000 patients (CARIM cohort) with a first myocardial infarction and undergoing reperfusion therapy in order to evaluate the impact of patient-related confounders on myocardial infarct size and LRI in order to further design a modeling of myocardial infarct size.
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 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient hospitalized in the cardiology department of the participating centers
- •Who have signed the Informed Consent Form.
- •Patient having health insurance.
- •Requiring PCI for reperfusion.
- •With a diagnosis of a first MI.
- •With ST segment elevation and/or Q wave at admission.
- •With troponin elevation.
- •Seen within the first 12 hours after symptom onset.
- •Aged between 18 and 90 years.
排除标准
- •Refusal of the patient.
- •In case of poor echogenicity, the participation of the patient will be stopped.
- •Patient with diagnosis of previous MI, or hypertrophic or dilated cardiomyopathy, or significant valvular heart disease, or chronic atrial fibrillation, or pace maker or any permanent implanted device susceptible to interfere with LV remodeling.
- •Patient with preexisting heart failure.
- •Patient with any previous cardiac surgery.
- •Patient with previous chemotherapy susceptible to induce LV remodeling (anthracyclines).
- •Patient with an associated short-time life-threatening disease.
- •Pregnant or breast-feeding patient.
- •Contra-indication to MRI (claustrophobia, pacemaker or any other metallic implants, creatinin clearance < 30mL/min/1.73m2 MDRD).
结局指标
主要结局
Determinants of myocardial infarct injury
时间窗: 5 years
次要结局
未报告次要终点