NCT06198777招募中不适用
Establishing Reference Intervals for Magnetocardiography Parameters in Healthy Adults in China
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,396
- 试验地点
- 1
- 主要终点
- Reference value for NPM (physio-MCG parameter,%)
研究概览
简要总结
Magnetocardiography (MCG) is a promising noninvasive and accurate method for detecting cardiac abnormalities. However, the results of MCG cannot be evaluated without defined reference intervals. This is a multicenter cross-sectional study designed to establish reference values for MCG parameters healthy adults in China.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 years or older.
- •Those with no hospitalization for any reason in the 6 months prior to the study.
- •Those who are not currently taking any prescribed medications.
- •Those with no history of cardiovascular diseases, including coronary artery disease, structural heart disease, arrhythmia, heart failure, stroke, pulmonary embolism, aortic coarctation, or peripheral arterial disease.
- •Those with no risk factors for cardiovascular diseases, including hypertension, diabetes mellitus, hyperlipidemia.
- •Those with no history of smoking (previous non-smoking or smoking cessation >6 months).
- •Those with no excessive alcohol consumption (average daily alcohol consumption <3 drinks, 1 drink = beer 355mL / white wine 44mL / red wine 118mL).
- •Signed informed consent.
排除标准
- •Those with body mass index >28kg/m2 or <18kg/m
- •Those with resting heart rate <50 beats/min, or >110 beats/min.
- •Those with resting systolic blood pressure ≥ 140 mmHg, and/or diastolic blood pressure ≥ 90 mmHg.
- •Those with fasting blood glucose ≥7 mmol/L, and/or random blood glucose ≥11.1 mmol/L.
- •Those with total cholesterol ≥6.2 mmol/L or low-density lipoprotein cholesterol ≥4.1 mmol/L.
- •Those with abnormal electrocardiograms, such as arrhythmias, ST-T changes, and pathologic electrical axis deflections.
- •Those with cardiac ultrasonographic pathologic findings, such as left ventricular hypertrophy, left ventricular dilatation, abnormal ventricular wall motion, and valvular regurgitation or stenosis of more than mild degree.
- •Those with respiratory diseases, kidney diseases, liver diseases, endocrine diseases, anaemia or other blood diseases, connective tissue diseases, malignant tumors and other diseases.
- •Professional athletes, pregnant or lactating women, psychological or psychiatric disorders such as depression.
- •Those who are unable to perform magnetocardiography due to claustrophobia, etc., or those who are unable to cooperate with the corresponding examinations required by the study for various reasons.
结局指标
主要结局
Reference value for NPM (physio-MCG parameter,%)
时间窗: from the date of enrollment until the date of the completion of all assessments, up to 30 days
MCG device is used for the measurement of the physio-MCG parameter, and we will calculate the reference value.
次要结局
- Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of R wave peak(from the date of enrollment until the date of the completion of all assessments, up to 30 days)
- Reference value for TCV (total current vector) angle at the timepoint of T wave peak(from the date of enrollment until the date of the completion of all assessments, up to 30 days)
- Reference value for TCV (total current vector) angle at the timepoint of R wave peak(from the date of enrollment until the date of the completion of all assessments, up to 30 days)
- Reference value for MCV (maximum current vector) amplitude (pT/m) at the timepoint of T wave peak(from the date of enrollment until the date of the completion of all assessments, up to 30 days)
研究者
研究点 (1)
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