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临床试验 NCT04537871 针对急性淋巴细胞白血病，急性髓性白血病，造血和淋巴细胞肿瘤，霍奇金淋巴瘤，骨髓增生异常综合症，非霍奇金淋巴瘤，浆细胞骨髓瘤目前进行中但不再招募。请查看临床试验雷达卡片视图和 AI 发现工具了解所有详情，或在此提出任何问题。 | ||
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希望之城国家医学中心Cardiovascular Reserve Evaluation in Survivors of Transplant, CREST Study
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临床试验NCT04537871是一项针对急性淋巴细胞白血病，急性髓性白血病，造血和淋巴细胞肿瘤，霍奇金淋巴瘤，骨髓增生异常综合症，非霍奇金淋巴瘤，浆细胞骨髓瘤的观察研究试验，目前试验状态为进行中但不再招募。试验始于2020年11月18日，计划招募350名患者。该研究由希望之城国家医学中心主导，预计于2026年6月30日完成。试验数据来源于ClinicalTrials.gov，最后更新时间为2025年9月25日。
简要概括
This study evaluates how well the heart, lungs, and muscles are working individually, and how these systems are working together in transplant survivors. Information collected in this study may help doctors to understand why hematopoietic stem cell transplant survivors are at higher risk for developing cardiovascular disease.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate cardiovascular reserve capacity, as measured by peak oxygen consumption (VO2peak), in hematopoietic cell transplantation (HCT) survivors.
II. Define the determinants of VO2peak impairment in HCT survivors.
OUTLINE:
Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant.
官方标题
Cardiovascular Reserve Evaluation in Survivors of Transplantation (CREST)
疾病
急性淋巴细胞白血病急性髓性白血病造血和淋巴细胞肿瘤霍奇金淋巴瘤骨髓增生异常综合症非霍奇金淋巴瘤浆细胞骨髓瘤其他研究标识符
- 19424
- NCI-2020-06749 (注册标识符) (CTRP (Clinical Trial Reporting Program))
- 19424 (其他标识符) (City of Hope Medical Center)
- P30CA033572 (美国 NIH 拨款/合同)
- R01HL150069 (美国 NIH 拨款/合同)
试验组/干预措施
| 参与者组/试验组 | 干预措施/治疗方法 |
|---|---|
Observational (physical assessment) Patients undergo echocardiogram to assess cardiac function and mechanics, cardiopulmonary exercise test, pulmonary function test, musculoskeletal ultrasound, bioelectrical impedance analysis to measure total lean body mass and percent body fat), physical function tests, and collection of blood samples within 45 days from the start of conditioning therapy, and at 6 months, 1 year, and 2 years post-transplant. | 生物电阻抗分析 Undergo bioelectric impedance analysis 生物样本采集 Undergo collection of blood samples 心肺运动测试 Undergo cardiopulmonary exercise test 超声心动图 Undergo echocardiogram 身体性能测试 Undergo physical function tests 肺功能测试 Undergo pulmonary function test 问卷管理 Ancillary studies 超声 Undergo musculoskeletal ultrasound |
主要终点
| 结果指标 | 度量标准描述 | 时间框架 |
|---|---|---|
Cardiovascular reserve capacity, as measured by VO2peak, in HCT survivors | We will measure initial VO2peak in patients prior to HCT and its post-HCT trajectory over time; compare VO2peak in HCT survivors at baseline (pre-HCT), 6m, 1Y, and 2Y post-HCT to established age- and sex-normative data; and define the association between VO2peak and self-reported health-related quality of life (HRQOL) at baseline/over time. | Up to 24 months post-hematopoietic cell transplantation (HCT) |
Determinants of VO2peak impairment in HCT survivors | We will use Generalized Estimating Equation(GEE) and generalized linear models to examine the correlation between VO2peak and measures of:
1. cardiac (left ventricular function/ contractility \[systolic, diastolic, cardiac output, strain\], ventricular-arterial (VA) coupling, arterial elastance);
2. pulmonary (obstructive, restrictive lung disease, diffusion capacity);
3. musculoskeletal (body composition \[% lean muscle mass\], muscle quality, two minute step in place test, 30 second sit to stand test, timed up and go); and
4. hematologic function, adjusting for potential confounding variables (e.g. age, sex) and time since HCT. | Up to 24 months post-hematopoietic cell transplantation (HCT) |
资格标准
适龄参与研究
成人, 老年人
最低年龄要求
18 Years
适龄性别
全部
- Age at HCT >= 18 years
- Diagnosis of acute leukemia (myeloid, lymphoid), lymphoma (non-Hodgkin, Hodgkin), multiple myeloma or myelodysplastic syndromes
- Planning to undergo first autologous or allogeneic transplant
- Able to fluently read and write in English
- Able to understand and sign the study specific informed consent form (ICF)
- Physically able and willing to complete all study procedures
- Unstable bone lesions per electronic medical record review and/or notification from patient's primary physician
- Unstable angina or history of acute myocardial Infarction (< 5 days of any planned study procedures)
- Recurrent syncope
- Acute myocarditis or pericarditis
- Symptomatic severe aortic stenosis
- Uncontrolled arrhythmia causing symptoms
- Pulmonary embolus < 3 month of study procedures
- Thrombosis of lower extremities
- Moderate or severe persistent asthma (National Asthma Education & Prevention)
- Room air desaturation at rest =< 85%
- Non-cardiopulmonary disorders that may affect exercise performance or be aggravated by exercise (i.e. infection, renal failure, thyrotoxicosis)
- Anemia (hemoglobin [Hgb] < 8 g/dL)
希望之城国家医学中心344 个活跃的临床试验可供探索- 国家癌症研究所3028 个活跃的临床试验可供探索
- 国家心脏、肺和血液研究所758 个活跃的临床试验可供探索
没有联系数据。
1 位于 1 个国家/地区的研究中心
California
City of Hope Medical Center, Duarte, California, 91010, United States