Assessment of Coronary Artery Disease in Asymptomatic Survivors of Allogeneic Hematopoietic Cell Transplantation (HCT): A Pilot Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Feasibility, defined by the percentage of patients that enroll onto the study, successful completion of all study measurements, ability of studies to be interpreted, and achievement of the recruitment goal
研究概览
简要总结
This pilot clinical trial studies computed tomography (CT) scans and biomarker analysis in diagnosing coronary artery disease (CAD) in patients who have undergone a stem cell transplant but have no symptoms of CAD. CAD is a disease in which there is a narrowing or blockage of the coronary arteries (blood vessels that carry blood and oxygen to the heart) and patients who have undergone a stem cell transplant are at an especially high risk for CAD. A CT scan involves a series of detailed pictures of areas inside the body taken from different angles. The pictures are created by a computer linked to an x-ray machine. Studying samples of blood from patients who have undergone a stem cell transplant in the laboratory may help doctors identify and learn more about biomarkers related to CAD. Using a CT scan in combination with biomarker analysis may be a better and less-invasive way to diagnose CAD.
详细描述
PRIMARY OBJECTIVES:
I. Evaluate the feasibility of using CT-based imaging and blood biomarkers for assessment of asymptomatic coronary artery disease (CAD) in survivors of allogeneic hematopoietic stem cell transplant (HCT).
SECONDARY OBJECTIVES:
I. Determine the prevalence and severity of asymptomatic CAD, as measured by CT angiography.
II. Describe the association between patient demographics (age, sex, race/ethnicity), pre-HCT chest radiation, HCT-related exposures (total body irradiation [TBI], conditioning chemotherapy), graft-versus-host disease (GvHD) and its management and cardiovascular risk factors (CVRFs) on extent of CAD.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 45 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Alive and in complete remission at time of enrollment
- •Underwent allogeneic HCT after 1995
- •Time between HCT and study entry: >= 2 years
- •Have at least one CVRF (hypertension, diabetes, dyslipidemia) at the time of eligibility determination
排除标准
- •History of ischemic heart disease, stroke, or cardiomyopathy/congestive heart failure
- •Abnormal renal function (glomerular filtration rate [GFR] < 60 mL/min/1.73m2)
- •Pregnancy
- •Known allergy to intravenous (IV) contrast
- •Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device; significant conduction defects (i.e.: second or third degree atrioventricular block or sick sinus syndrome)
- •Current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e.: asthma) requiring therapy
- •History of drug sensitivity or allergic reaction to beta-blockers
- •Currently taking calcium channel blockers such as verapramil and diltiazem
- •History of unrepaired severe aortic stenosis
结局指标
主要结局
Feasibility, defined by the percentage of patients that enroll onto the study, successful completion of all study measurements, ability of studies to be interpreted, and achievement of the recruitment goal
时间窗: Up to 9 weeks
The current protocol will be considered feasible if: 1) \>= 30% of eligible patients that are approached for participation enroll onto the study, 2) \>= 75% enrolled participants successfully complete all study measurements (history/physical examination, blood draw, completion of study questionnaires, CT-imaging), 3) \>= 90% of CT-based studies can be interpreted and 4) =\< 100 individuals are approached to achieve recruitment goal of 20 participants.
次要结局
未报告次要终点