NCT07549477
Recruiting
Not Applicable
Mechanistic and Prognostic Evaluation of Central Venous Catheter-Associated Right Atrial Thrombus
Memorial Sloan Kettering Cancer Center7 sites in 1 country150 target enrollmentStarted: April 15, 2026Last updated:
InterventionsCardiac MRI
Overview
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 150
- Locations
- 7
- Primary Endpoint
- association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue
Overview
Brief Summary
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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:
Exclusion Criteria
- •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
Arms & Interventions
Participants in the RA Clot Group will have confirmed RA clots
Experimental
Intervention: Cardiac MRI (Diagnostic Test)
Outcomes
Primary Outcomes
association between Central venous catheter-associated right atrial thrombus (RATHR) with Cardiac MRI (CMR) tissue
Time Frame: 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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (7)
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