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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorSt. Jude Children's Research Hospital

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

Age ≥18 years

Enrolled in the St. Jude Lifetime Cohort (SJLIFE)

Participant or legal guardian/representative is able and willing to give informed consent.

Disqualifiers

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.

Trial population

Participants are identified through existing enrollment in the St. Jude Lifetime Cohort (SJLIFE). Childhood cancer survivors are selected based on prior cancer treatment exposures associated with increased risk of atherosclerotic cardiovascular disease and are invited to participate during scheduled SJLIFE evaluations. Community control participants are selected from the SJLIFE comparison group and are frequency matched to survivors by age and sex. Participation is voluntary, and no randomization is used.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

  • Coronary Artery Calcium Scan

    Diagnostic test

    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.

  • Carotid Artery Ultrasound

    Diagnostic test

    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.

  • Lipoprotein(a) Measurement

    Diagnostic test

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

  • Vascular Function Testing

    Diagnostic test

    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.

Treatment groups

650 Participants
are divided into 2 treatment groups
Group A: Childhood Cancer Survivors4 interventions
Group B: Community Controls4 interventions

Trial outcomes

Primary outcomes

1

Determine the prevalence of abnormal coronary artery calcium score among survivors with cancer treatment exposures associated with increased risk for ASCVD and ischemic heart disease overall and in comparison to community controls.

Coronary artery calcium (CAC) score (Agatston score) reported as a whole number and then categorized as abnormal first as CAC\>0 and then as CAC\>100.

Time frame
Baseline
2

Determine the prevalence of carotid stenosis using carotid ultrasound among survivors with cancer treatment exposures associated with increased risk for ASCVD and stroke overall in comparison to community controls.

Carotid artery stenosis as a percentage (%) and then as abnormal (Y/N) with abnormal considered stenosis at least 50% in either the L or R carotid artery.

Time frame
Baseline

Secondary outcomes

1

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.

Lipoprotein (a) levels will be measured from a blood sample and reported in mg/dL.

Time frame
Baseline
2

Evaluate prevalence of clinical and imaging markers of ASCVD risk among survivors exposed only to platinum chemotherapy and compare that to community controls.

The prevalence of CAC \>0 (or CAC\>100) and then carotid stenosis of at least 50% in survivors exposed only to platinum chemotherapy and then community controls.

Time frame
Baseline

Other outcomes

Sponsors and contacts

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St. Jude Children's Research Hospital

Lead sponsor

National Cancer Institute (NCI)

Collaborator