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NCT07594392
Clinical Assessment and Targeted Imaging to Characterize High-Risk Atherosclerotic Cardiovascular Disease of Survivors in SJLIFE
Conditions: Atherosclerotic Cardiovascular Disease
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Enrollment: 650
Sponsor: St. Jude Children's Research Hospital
Location: St. Jude Children's Research Hospital Memphis Tennessee
Summary
Childhood cancer survivors are at increased risk for premature atherosclerotic cardiovascular disease (ASCVD) due to cancer treatment-related exposures, including radiation therapy and platinum-based chemotherapy. Current ASCVD risk assessment tools may underestimate cardiovascular risk in younger survivors. This observational study performs detailed cardiovascular phenotyping using imaging, blood-based biomarkers, and vascular function testing among adult survivors enrolled in the St. Jude Lifetime Cohort (SJLIFE), with comparison to community controls, to better characterize subclinical ASCVD risk and inform survivor-specific prevention strategies.
Primary Objective:
Perform deeper phenotyping of SJLIFE participants at treatment-related risk of atherosclerotic cardiovascular disease \[ASCVD\] to facilitate early detection of pathophysiological targets appropriate for remediation.
Secondary Objectives:
Determine the distribution of lipoprotein (a) levels and prevalence of elevated levels among survivors with any treatment related exposure-based risk for ASCVD overall and then compared to community controls.
Evaluate prevalence of clinical and imaging markers of ASCVD risk among survivors exposed only to platinum chemotherapy and compare that to community controls.
Eligibility Criteria
Inclusion Criteria:
\- SJLIFE Survivor or Control
* Age ≥18 years
* Enrolled in the St. Jude Lifetime Cohort (SJLIFE)
* Participant or legal guardian/representative is able and willing to give informed consent.
SJLIFE Survivor only
* Participant has been treated with at least one of the following cancer therapies:
platinum chemotherapy, neck radiation exposure of at least 1000 centigray (cGy), or chest radiation exposure of at least 1000 cGy (with potential exposure to the heart).
Exclusion Criteria:
SJLIFE Survivor or Control
* Previous stroke or intervention for severe carotid arterial disease including carotid endarterectomy or carotid angioplasty and stent placement.
* Previous myocardial infarction or intervention for severe cardiovascular disease including Coronary Artery Bypass Graft (CABG), coronary stent placement or coronary angioplasty.
* History of aortic valve replacement
* Inability or unwillingness of research participant or legal guardian/representative to give written informed consent.
Control Only
* First degree relative of SJLIFE Survivor
* History of cancer
Source: ClinicalTrials.gov (NCT07594392). StuddyBuddy aggregates publicly available trial information.