Recruiting

Cardiovascular Risk

Sponsor:

St. Jude Children's Research Hospital

Code:

NCT07594392

Conditions

Atherosclerotic Cardiovascular Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Coronary Artery Calcium Scan

Carotid Artery Ultrasound

Lipoprotein(a) Measurement

Vascular Function Testing

Study Details

Brief 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. 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.

Conditions

Atherosclerotic Cardiovascular Disease

Study ID

NCT07594392

Start date

Sep 21, 2026

Status verified date

Sep, 2026

Completion date

Jun, 2031

Anticipated

Primary completion date

Jun, 2030

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Community Controls

Adult community control participants enrolled in SJLIFE without a history of cancer, frequency matched to survivors by age and sex.

Interventions

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.

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.

Lipoprotein(a) Measurement

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

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.

Primary outcome measure

  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Stephanie B Dixon, MD, MPH

888-226-4343referralinfo@stjude.org

Locations

St. Jude Children's Research Hospital

Recruiting

Memphis, Tennessee, United States, 38104

Contacts

Stephanie B Dixon, MD, MPH

888-226-4343referralinfo@stjude.org

More Information

Sponsor

St. Jude Children's Research Hospital

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Childhood Cancer Survivors
  • ASCVD

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-25. This information was provided to ClinicalTrials.gov by St. Jude Children's Research Hospital on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.