NCT07549477招募中不适用
Mechanistic and Prognostic Evaluation of Central Venous Catheter-Associated Right Atrial Thrombus
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 7
- 主要终点
- association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue
研究概览
简要总结
The researchers are doing this study to see how well cardiac magnetic resonance imaging (CMR) scans can be used to examine the properties of central venous catheter-associated right atrial clot (RA clot). This could help doctors decide on the best treatment options.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Documentation of Disease
- •o Patients must have pathologically confirmed systemic cancer of any types and stages (solid tumors or hematologic malignancies) at the time of CMR which will be used to evaluate the presence or absence of cardiac mass and additional tissue characterization for confirmation of RATHR.
- •Definition of Disease [or Measurable Disease]
- •Cardiac mass (CMASS) will be initially localized on cine-CMR, on which it is defined via established criteria as a discrete tissue prominence independent from normal anatomic structures, quantified based on size (area, cross-sectional linear dimensions)
- •CMASS will be further categorized by type (CNEO or CTHR) based on CMR tissue characterization: CNEO and CTHR can be differentiated based on presence of contrast enhancement via the reference standard of LGE-CMR using established criteria previously validated by our group and others.
- •CTHR is defined as discrete mass(es) with avascular tissue properties (enhancement absent).
- •CTHR will be further subgrouped into RATHR after confirmation of its location and in relation to CVC.
- •CNEO is defined as discrete mass(es) with vascular tissue properties (enhancement present),
- •CNEO can be further sub-typed based on visually scored magnitude of enhancement (diffusely hyper-enhancing, mixed, predominantly hypo-enhancing) in accordance with established methods previously used by our group.
- •Required Organ Function:
- •o Adequate renal function defined as follows:
- •Creatinine clearance (CrCL) of ≥30 mL/min by the Cockcroft-Gault formula (Note: For agents for which renal excretion is not a major route of clearance and for which renal toxicity is not an issue, the threshold for creatinine clearance should be ≥30 mL/min.):
- •CrCl (mL/min) = [140 - age (years)] x weight (kg) 72 * creatinine (mg / dL)
- •Allergies
- •No history of allergic reaction to the gadolinium contrast agent or compounds of similar chemical or biologic composition
- •Subjects in RATHR+ group must meet the following criteria:
- •Adult cancer patients (stage I-IV) who are greater than 18 years of age
- •Presence of indwelling central venous catheter (Mediport, PICC, Hickman, pheresis cath, etc) with a minimal duration of 7 days prior to CMR
- •Presence of RATHR based on established CMR criteria (i.e. absence of enhancement on LGE-CMR)
- •Patients who underwent CMR within the past 3 months for evaluation of cardiac masses are eligible if confirmed for the presence of RATHR
排除标准
- •Known pre-existing CV disease which can affect hemodynamics within cardiac chambers as determined by the investigator, including
- •Arrhythmia - chronic persistent atrial arrhythmias
- •Cardiomyopathies including Ischemic or non-ischemic cardiomyopathy with LVEF <53%
- •Restrictive cardiomyopathy - cardiac amyloidosis, myocardial fibrosis
- •Constrictive pericarditis
- •Valvular heart disease with equal to or greater than moderate stenosis or regurgitation
- •Cardiac neoplastic involvement
- •Subjects will be excluded if they are unable to provide informed consent due to underlying clinical conditions and mental status.
- •Subjects will be excluded for getting CMR if they are
- •Subjects who would be normally excluded from undergoing a MRI examination as per institutional standard of care. At MSK, patients will be screened by radiology technicians using Memorial Hospital for Cancer and Allied Diseases Screening Questionnaire (Appendix 1) prior to getting cardiac MRI
- •Subjects with presence of MRI incompatible metal fragments, aneurysm clip, implants or devices that would warrant avoidance of a strong magnetic field
- •Contraindications to receive gadolinium contrast
- •Renal dysfunction (GFR <30 mL/min) or end stage renal disease
- •Prior allergic reaction to gadolinium
- •Subject who are unable to tolerate CMR due to clinical status, respiratory compromise, or severe claustrophobia
- •Female participants who are pregnant or nursing
- •Subjects defined as vulnerable populations, as defined by 45 CFR 46
- •Participants at higher risk due to age, frailty, or the emergent nature of their condition
研究组 & 干预措施
Participants in the RA Clot Group will have confirmed RA clots
Experimental
干预措施: Cardiac MRI (Diagnostic Test)
结局指标
主要结局
association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue
时间窗: up to 3 months
Quantitative tissue characterization of RATHR will be employed to measure RATHR organization based on contrast infiltration, T1 variability altered T2\*10 and susceptibility. These will be used to determine chronicity of thrombi as a predictor of therapeutic response to anticoagulation. Analyses will also include assessment of RATHR size, and geometry (border irregularity) at baseline and at 3-month follow up CMR using established methods to assess for the degree of resolution of RATHR.
次要结局
未报告次要终点
研究者
研究点 (7)
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