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

3 september 2026 uppdaterad av: 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.

Studieöversikt

Status

Har inte rekryterat ännu

Betingelser

Intervention / Behandling

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Beräknad)

650

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studiekontakt

Studieorter

  • Förenta staterna
    • Tennessee
      • Memphis, Tennessee, Förenta staterna, 38104
        • St. Jude Children's Research Hospital
        • Kontakt:

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Testmetod

Icke-sannolikhetsprov

Studera befolkning

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.

Beskrivning

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

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

Kohorter och interventioner

Grupp / Kohort
Intervention / Behandling
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.
Diagnostiskt 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.
Diagnostiskt 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.
Diagnostiskt test: Lipoprotein(a) Measurement
Peripheral blood draw for measurement of serum lipoprotein(a) levels to identify ASCVD risk enhancing factors.
Diagnostiskt 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.
Diagnostiskt 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.
Diagnostiskt 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.
Diagnostiskt test: Lipoprotein(a) Measurement
Peripheral blood draw for measurement of serum lipoprotein(a) levels to identify ASCVD risk enhancing factors.
Diagnostiskt 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.

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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.
Tidsram: 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

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
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.
Tidsram: 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.
Tidsram: 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

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

St. Jude Children's Research Hospital

Samarbetspartners

National Cancer Institute (NCI)

Utredare

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

Publikationer och användbara länkar

Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.

Användbara länkar

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Beräknad)

1 oktober 2026

Primärt slutförande (Beräknad)

1 juni 2030

Avslutad studie (Beräknad)

1 juni 2031

Studieregistreringsdatum

Först inskickad

12 maj 2026

Först inskickad som uppfyllde QC-kriterierna

12 maj 2026

Första postat (Faktisk)

18 maj 2026

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

4 september 2026

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

3 september 2026

Senast verifierad

1 september 2026

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • CATCHASCVD
  • U01CA301480 (U.S.S. NIH-anslag/kontrakt)
  • NCI-2026-06411 (Annan identifierare: NCI Clinical Trials Reporting Program)

Plan för individuella deltagardata (IPD)

Planerar du att dela individuella deltagardata (IPD)?

JA

IPD-planbeskrivning

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.

Tidsram för IPD-delning

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

Kriterier för IPD Sharing Access

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-delning som stöder informationstyp

  • STUDY_PROTOCOL
  • SAV
  • ICF

Läkemedels- och apparatinformation, studiedokument

Studerar en amerikansk FDA-reglerad läkemedelsprodukt

Nej

Studerar en amerikansk FDA-reglerad produktprodukt

Nej

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