Atherosclerotic Cardiovascular DiseaseNCT07594392
Clinical Assessment and Targeted Imaging to Characterize High-Risk Atherosclerotic Cardiovascular Disease of Survivors in SJLIFE
An observational study of Atherosclerotic Cardiovascular Disease, run by St. Jude Children's Research Hospital at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atherosclerotic Cardiovascular Disease
- What is being tested?
- Coronary Artery Calcium Scan, Carotid Artery Ultrasound and Lipoprotein(a) Measurement
- How many people
- 650 participants
- Where
- 1 siteUnited States
- Study dates
- 21 Sep 2026to Jun 2031
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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).
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
St. Jude Children's Research Hospital
Memphis, Tennessee, 38104
Stephanie B Dixon, MD, MPH, 888-226-4343, referralinfo@stjude.org
About this study
Official title: 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:
Read more
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.
Read the 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.
- Conditions
- Atherosclerotic Cardiovascular Disease
- Being tested
- Coronary Artery Calcium Scan, Carotid Artery Ultrasound, Lipoprotein(a) Measurement, Vascular Function Testing
- Keywords
- Childhood Cancer Survivors, ASCVD
- Medical subject headings
- Atherosclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coronary Artery Calcium ScanDiagnostic 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 UltrasoundDiagnostic 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) MeasurementDiagnostic test
Peripheral blood draw for measurement of serum lipoprotein(a) levels to identify ASCVD risk enhancing factors.
Vascular Function TestingDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Coronary Artery Calcium Scan; Diagnostic Test: Carotid Artery Ultrasound; Diagnostic Test: Lipoprotein(a) Measurement; Diagnostic Test: Vascular Function Testing | |
| Community Controls | Adult community control participants enrolled in SJLIFE without a history of cancer, frequency matched to survivors by age and sex. Receives: Diagnostic Test: Coronary Artery Calcium Scan; Diagnostic Test: Carotid Artery Ultrasound; Diagnostic Test: Lipoprotein(a) Measurement; Diagnostic Test: Vascular Function Testing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
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.
Measured: Baseline
Secondary outcomes (2)
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.
Measured: Baseline
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.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2026
- Study start21 Sep 2026
- Primary completionJun 2030 (estimated)
- Study completionJun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atherosclerotic Cardiovascular DiseaseStudies of the same condition, open and under way.
- More trials run by St. Jude Children's Research HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- St. Jude Children's Research Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Stephanie B Dixon, MD, MPH, Principal investigator, St. Jude Children's Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07594392
- Sponsor's protocol ID
- CATCHASCVD
- Other IDs
- U01CA301480, NCI-2026-06411
- Status last verified
- Sep 2026
- First submitted
- 12 May 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.