NCT07676201尚未招募不适用
One-year Prognostic Impact of Microcirculation Assessed by NH IMR Angio in Patients Hospitalized for Acute Myocarditis
University Hospital, Grenoble0 个研究点目标入组 106 人开始时间: 2026年7月15日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 106
- 主要终点
- MACE
研究概览
简要总结
The goal of this observational study is to evaluate the association between post-coronary angiography IMR and medium-term clinical prognosis in patients with acute myocarditis. The main question it aims to answer is:
Is there a correlation between impaired microcirculation and the occurrence of serious clinical events in this population of patients?
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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
- •Male or female patients over the age of
- •Patients hospitalized between June 2015 and July
- •Patients who presented with chest pain and at least 1 diagnostic criterion; or, in the absence of chest pain, at least 2 of the following diagnostic criteria:
- •Electrocardiographic abnormalities (ST-segment elevation or depression, T-wave inversions, conduction disturbances such as type 3 atrioventricular block),
- •Elevated troponin levels,
- •Abnormal kinematics on echocardiography.
- •Associated with MRI findings of ≥2 tissue abnormalities (edema, hyperemia, myocardial fibrosis).
- •Coronary angiography performed during the initial hospitalization
- •Patient enrolled in or eligible for a social security program.
- •Patient who has expressed consent to participate.
排除标准
- •Absence of coronary artery disease confirmed by coronary angiography
- •Myocarditis secondary to immunotherapy
- •Presence of documented coronary artery disease (coronary angiography or cardiac CT)
- •Presence of cardiomyopathy (hypertrophic cardiomyopathy, dilated cardiomyopathy)
- •Infiltrative heart disease (sarcoidosis or cardiac amyloidosis)
- •Severe valvular heart disease
- •Takotsubo syndrome
- •Constrictive or chronic pericarditis
- •Loeffler's endocarditis
- •Left ventricular noncompaction
- •Cardiac tumor
- •Pulmonary embolism
- •Coronary spasm
- •Patients covered by Articles L1121-5 through L1121-8 of the Public Health Code (pregnant women, women in labor, and breastfeeding women; persons deprived of their liberty by judicial or administrative decision; adults under guardianship)
结局指标
主要结局
MACE
时间窗: From the time of the coronary angiography up to one year
The primary endpoint is the 1-year incidence rate of MACE. MACE is defined by a composite endpoint comprising: 1) all-cause mortality, 2) cardiac decompensation requiring readmission, 3) heart transplantation, 4) documented sustained ventricular arrhythmia lasting \>30 seconds, and 5) recurrence of myocarditis.
次要结局
- Predictive value of MRI angiography: diagnostic performance in predicting the primary endpoint (ROC, optimal cut-off values, sensitivity/specificity)(From the time of the coronary angiography up to one year)
- Assessment of inter- and intra-observer reproducibility of the MR angiography NH calculation (if a subsample is reanalyzed)(From the time of the coronary angiography up to one year)
- Individual components of the 12-month MACE: cardiovascular death, transplantation, hospitalization for heart failure, and persistent heart failure (reported separately)(From the time of the coronary angiography up to one year)
- Correlation between IMR angiographic NH (continuous variable) and: a) MRI imaging criteria (LVEF, fibrosis, septal involvement, edema); b) biological markers (maximum troponin, CRP)(From the time of the coronary angiography up to one year)
研究者
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