NCT03604627招募中不适用
Study of Coronary Calcium Score as a Marker of Post-radiation Vascular Dysplasia in Adults Treated During Childhood for Cancer With Mediastinal Irradiation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Incidence of a calcium score
研究概览
简要总结
To measure coronary calcium score in adults treated during childhood or adolescence for irradiation cancer in the heart and / or anthracycline area and compare them to determine whether irradiation of the heart area is associated with increased calcium score after adjustment for other cardiovascular risk factors (age, sex, smoking, dyslipidemia, obesity, diabetes, high blood pressure and renal failure).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 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
- •Patients 18 years of age or older,
- •Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
- •Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate) and / or anthracycline (cumulative dose of doxorubicin equivalent ≥300mg/m^²),
- •In complete remission of their pediatric cancer for at least 10 years,
- •Patient affiliated to a social security scheme or beneficiary of such a scheme,
- •Patient Information and Signed Informed Consent.
排除标准
- •Perspective less than 10 years,
- •Persons deprived of liberty or guardianship (including trusteeship),
- •Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
- •Pregnant women.
- •Inclusion criteria for extension cohort:
- •Patients 30 years of age or older,
- •Treated for cancer during childhood, adolescence or young adulthood (≤25 years),
- •Treated with irradiation of the heart area (≥20% of ≥5Gy heart rate),
- •In complete remission of their pediatric cancer for at least 10 years,
- •Patient affiliated to a social security scheme or beneficiary of such a scheme,
- •Patient Information and Signed Informed Consent.
- •Exclusion criteria for extension cohort:
- •Persons deprived of liberty or guardianship (including trusteeship),
- •Impossibility of submitting to the medical follow-up of the test for geographical, social or psychological reasons,
- •Pregnant women.
结局指标
主要结局
Incidence of a calcium score
时间窗: Up to 24 months
Incidence of a calcium score measured by the Agatston score\> 0 in the study population of adults treated during childhood or adolescence for cancer with irradiation of the heart area and / or treatment with anthracyclines
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Evaluation of Coronary Artery Calcification Using Gated Stationary Chest TomosynthesisCoronary Artery DiseaseNCT03169062University of North Carolina, Chapel Hill10
已完成
不适用
7 Year Follow-up Study of the DanRisk PopulationCoronary Artery CalcificationCardiovascular DiseaseAtherosclerosisNCT02913144Odense University Hospital1,257
已完成
不适用
Multi Detector-Row Computed Tomography (MDCT) Calcium Score of Heart Transplanted PatientsCoronary Artery DiseaseNCT00294853Oslo University Hospital240
招募中
不适用
Coronary calcium scoring as first-line test to detect and exclude coronary artery disease in GP patients with stable chest paicoronary artery diseasecoronary heart disease10011082NL-OMON55495niversitair Medisch Centrum Groningen1,600
已完成
不适用
Aorta Calcium ScoringCardiovascular DiseasesNCT00496717University Hospital, Strasbourg, France60