Clinical trial · Interventional
Accelerated Atherosclerosis in High Risk Population Groups: An Assessment by Magnetic Resonance Imaging
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): The study was stopped when the original principal investigator moved to a new institution.
Summary
Brief summary (as posted)
The goal of this study is to assess a slimy substance that settles/deposits along blood vessel wall. This slimy substance is called plaque. Plaque could be made up of fat, calcium or both. Plaque deposition narrows the vessels. This leads to decreased blood flow to various parts of body. Blood vessels include vessels that supply to heart (coronary), vessels to brain (carotid), vessels to kidneys (renal) and vessels to legs (femoral). Decreased blood flow causes symptoms such as brain stroke, heart attack, leg pain. Similarly individuals at risk of cardiovascular disease can have certain markers elevated in their blood that can be measured by simple blood tests. High or increased plaque deposition is seen in neck vessels of cancer patients who received radiation to chest or head and neck as part of their cancer treatment. Cancer survivors are at increased risk of plaque development and are therefore called high-risk population. Exercise +/- fat lowering medicine can potentially decrease plaque deposition and statins are one of the several fat lowering medications.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Atherosclerosis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Lifestyle modification | Behavioral | — | UNRESOLVED |
| Statin therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Lifestyle modification
- description
- Lifestyle modification is tailored to each participant and includes a recommended exercise regimen, a healthy diet and decreasing alcohol intake.
- interventionNames
- Behavioral: Lifestyle modification
- type
- EXPERIMENTAL
- label
- Statin therapy
- description
- Participants will receive statin medication along with instruction about regular exercise.
- interventionNames
- Drug: Statin therapy
Primary outcomes (1)
- measure
- Plaque Volume of Carotid Arteries
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 22 Years
Show eligibility criteria text
Inclusion Criteria: * Age 22 and above with prior head and neck or chest irradiation * Six months or more post head and neck irradiation * Documented subclinical cardiovascular disease (inflammatory markers in the serum) * Pre-existing plaques (detected by ultrasound, CT or MRI) * Asymptomatic major arterial stenosis * Not being considered for arterial surgery or endovascular treatment. Exclusion Criteria: * Recurrence of cancer (with or without treatment) * Planned surgical or endovascular intervention for revascularization of carotid arteries at the time of enrollment * Renal failure * Estimated glomerular filtration rate (eGFR) \< 45 (calculation based on serum creatinine levels, race, age and gender) * Medically unstable or hematologic, renal, or hepatic dysfunction * Non-atherosclerotic arterial stenosis (dissection) * Presence of stents or external clips that can cause artifacts impairing accurate interpretation of MRI data * Contraindications to MRI: cardiac pacemaker, metal implants, metal in eyes, pregnant or nursing women, claustrophobia, allergy to MRI contrast * Physical or mental impairment that would limit the patient's ability to comply with the medical instructions or study procedures
References
Publications (34)
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- BACKGROUNDVirmani R, Burke AP, Kolodgie FD, Farb A. Vulnerable plaque: the pathology of unstable coronary lesions. J Interv Cardiol. 2002 Dec;15(6):439-46. doi: 10.1111/j.1540-8183.2002.tb01087.x. PMID 12476646
- BACKGROUNDYeh JM, Nekhlyudov L, Goldie SJ, Mertens AC, Diller L. A model-based estimate of cumulative excess mortality in survivors of childhood cancer. Ann Intern Med. 2010 Apr 6;152(7):409-17, W131-8. doi: 10.7326/0003-4819-152-7-201004060-00005. PMID 20368646
- BACKGROUNDDorresteijn LD, Kappelle AC, Boogerd W, Klokman WJ, Balm AJ, Keus RB, van Leeuwen FE, Bartelink H. Increased risk of ischemic stroke after radiotherapy on the neck in patients younger than 60 years. J Clin Oncol. 2002 Jan 1;20(1):282-8. doi: 10.1200/JCO.2002.20.1.282. PMID 11773180
- BACKGROUNDJordan LC, Duffner PK. Early-onset stroke and cerebrovascular disease in adult survivors of childhood cancer. Neurology. 2009 Dec 1;73(22):1816-7. doi: 10.1212/WNL.0b013e3181c33b10. Epub 2009 Oct 21. No abstract available. PMID 19846829
- BACKGROUNDDiller L, Chow EJ, Gurney JG, Hudson MM, Kadin-Lottick NS, Kawashima TI, Leisenring WM, Meacham LR, Mertens AC, Mulrooney DA, Oeffinger KC, Packer RJ, Robison LL, Sklar CA. Chronic disease in the Childhood Cancer Survivor Study cohort: a review of published findings. J Clin Oncol. 2009 May 10;27(14):2339-55. doi: 10.1200/JCO.2008.21.1953. Epub 2009 Apr 13. No abstract available. PMID 19364955
- Mertens AC, Yasui Y, Neglia JP, Potter JD, Nesbit ME Jr, Ruccione K, Smithson WA, Robison LL. Late mortality experience in five-year survivors of childhood and adolescent cancer: the Childhood Cancer Survivor Study. J Clin Oncol. 2001 Jul 1;19(13):3163-72. doi: 10.1200/JCO.2001.19.13.3163.