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

May 19, 2026 updated by: St. Jude Children's Research Hospital

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Survivors of childhood cancer experience substantially increased risk of ischemic heart disease and stroke compared to the general population. This excess risk is largely driven by cancer therapy exposures such as chest or neck radiation and platinum-based chemotherapy. However, most evidence-based ASCVD screening and prevention guidelines are derived from populations aged 40 years or older without cancer therapy exposure, leaving younger survivors inadequately risk stratified.

This study leverages the St. Jude Lifetime Cohort (SJLIFE) to conduct enhanced cardiovascular phenotyping among survivors at treatment-related risk for ASCVD. Participants undergo coronary artery calcium (CAC) scoring using low-dose non-contrast ECG-gated CT, bilateral carotid ultrasound to assess carotid stenosis and intima-media thickness, blood-based measurement of lipoprotein(a), and noninvasive vascular function testing including pulse wave velocity, augmentation index, and arterial elasticity. A cohort of community control participants enrolled in SJLIFE undergoes identical testing.

The primary objectives are to determine the prevalence of abnormal CAC and carotid stenosis among at-risk survivors and to compare findings with community controls. Secondary objectives include characterization of lipoprotein(a) levels and assessment of ASCVD markers among survivors exposed solely to platinum chemotherapy.

The study uses a cross-sectional design with prospective longitudinal follow-up through ongoing participation in SJLIFE. Results are intended to inform future survivor-specific screening approaches and interventional trials.

Study Type

Observational

Enrollment (Estimated)

650

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Tennessee
      • Memphis, Tennessee, United States, 38104
        • St. Jude Children's Research Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study 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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Childhood Cancer Survivors
Adult survivors enrolled in SJLIFE with prior exposure to cancer treatments associated with increased risk for ASCVD, including chest radiation, neck radiation, and/or platinum-based chemotherapy.
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.
Community Controls
Adult community control participants enrolled in SJLIFE without a history of cancer, frequency matched to survivors by age and sex.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
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.
Baseline
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.
Time Frame: Baseline
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.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: Baseline
Lipoprotein (a) levels will be measured from a blood sample and reported in mg/dL.
Baseline
Evaluate prevalence of clinical and imaging markers of ASCVD risk among survivors exposed only to platinum chemotherapy and compare that to community controls.
Time Frame: Baseline
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.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

St. Jude Children's Research Hospital

Investigators

  • Principal Investigator: Stephanie B Dixon, MD, MPH, St. Jude Children's Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2030

Study Completion (Estimated)

June 1, 2031

Study Registration Dates

First Submitted

May 12, 2026

First Submitted That Met QC Criteria

May 12, 2026

First Posted (Actual)

May 18, 2026

Study Record Updates

Last Update Posted (Actual)

May 22, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CATCHASCVD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Individual participant de-identified datasets containing the variables analyzed in the published article will be made available (related to the study primary or secondary objectives contained in the publication). Supporting documents such as the protocol, statistical analyses plan, and informed consent are available through the ClinicalTrials.gov website for the specific study. Data used to generate the published article will be made available at the time of article publication. Investigators who seek access to individual level de-identified data will contact the computing team in the Department of Biostatistics (ClinTrialDataRequest@stjude.org) who will respond to the data request.

IPD Sharing Time Frame

Data will be made available at the time of article publication.

IPD Sharing Access Criteria

Data will be provided to researchers following a formal request with the following information: full name of requestor, affiliation, data set requested, and timing of when data is needed. As an informational point, the lead statistician and study principal investigator will be informed that primary results datasets have been requested.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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