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

3 de setembro de 2026 atualizado por: 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.

Visão geral do estudo

Status

Ainda não está recrutando

Condições

Intervenção / Tratamento

Descrição detalhada

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.

Tipo de estudo

Observacional

Inscrição (Estimado)

650

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Contato de estudo

Locais de estudo

  • Estados Unidos
    • Tennessee
      • Memphis, Tennessee, Estados Unidos, 38104
        • St. Jude Children's Research Hospital
        • Contato:

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

  • Adulto
  • Adulto mais velho

Aceita Voluntários Saudáveis

Não

Método de amostragem

Amostra Não Probabilística

População do estudo

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.

Descrição

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

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

Coortes e Intervenções

Grupo / Coorte
Intervenção / Tratamento
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.
Teste de diagnostico: 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.
Teste de diagnostico: 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.
Teste de diagnostico: Lipoprotein(a) Measurement
Peripheral blood draw for measurement of serum lipoprotein(a) levels to identify ASCVD risk enhancing factors.
Teste de diagnostico: 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.
Teste de diagnostico: 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.
Teste de diagnostico: 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.
Teste de diagnostico: Lipoprotein(a) Measurement
Peripheral blood draw for measurement of serum lipoprotein(a) levels to identify ASCVD risk enhancing factors.
Teste de diagnostico: 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.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
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.
Prazo: 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.
Prazo: 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

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

St. Jude Children's Research Hospital

Colaboradores

National Cancer Institute (NCI)

Investigadores

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

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Links úteis

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Estimado)

1 de outubro de 2026

Conclusão Primária (Estimado)

1 de junho de 2030

Conclusão do estudo (Estimado)

1 de junho de 2031

Datas de inscrição no estudo

Enviado pela primeira vez

12 de maio de 2026

Enviado pela primeira vez que atendeu aos critérios de CQ

12 de maio de 2026

Primeira postagem (Real)

18 de maio de 2026

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de setembro de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

3 de setembro de 2026

Última verificação

1 de setembro de 2026

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • CATCHASCVD
  • U01CA301480 (Concessão/Contrato do NIH dos EUA)
  • NCI-2026-06411 (Outro identificador: NCI Clinical Trials Reporting Program)

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

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.

Prazo de Compartilhamento de IPD

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

Critérios de acesso de compartilhamento IPD

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.

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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