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NOT YET RECRUITING
NCT07594392

Clinical Assessment and Targeted Imaging to Characterize High-Risk Atherosclerotic Cardiovascular Disease of Survivors in SJLIFE

Sponsor: St. Jude Children's Research Hospital

View on ClinicalTrials.gov

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.

Official title: Clinical Assessment and Targeted Imaging to Characterize High-Risk Atherosclerotic Cardiovascular Disease of Survivors in the St. Jude Lifetime Cohort (SJLIFE)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

650

Start Date

2026-08

Completion Date

2031-06

Last Updated

2026-08-25

Healthy Volunteers

No

Interventions

DIAGNOSTIC_TEST

Coronary Artery Calcium Scan

Low dose, ECG gated, non contrast cardiac computed tomography (CT) scan performed to quantify coronary artery calcium using the Agatston scoring method for assessment of subclinical coronary atherosclerosis.

DIAGNOSTIC_TEST

Carotid Artery Ultrasound

Bilateral high resolution B mode carotid ultrasound with color and spectral Doppler interrogation of the common carotid artery, carotid bulb, and internal carotid artery to assess carotid plaque, stenosis, and intima-media thickness.

DIAGNOSTIC_TEST

Lipoprotein(a) Measurement

Peripheral blood draw for measurement of serum lipoprotein(a) levels to identify ASCVD risk enhancing factors.

DIAGNOSTIC_TEST

Vascular Function Testing

Non invasive vascular function assessments including pulse wave velocity, augmentation index, and arterial elasticity using FDA cleared devices (e.g., SphygmoCor XCEL and HDI/PulseWave CR-2000) to evaluate arterial stiffness and vascular health.

Locations (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, United States