NCT05490875已完成不适用
A Pilot Study of Carotid Ultrasound to Identify Head and Neck Cancer Survivors With High Cardiovascular Risk After Radiation Therapy
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Number of Participants with 50% Stenosis Identified
研究概览
简要总结
The purpose of this research study is to understand how radiation therapy may affect blood vessels in the neck called the carotid arteries. Investigators want to look at narrowing of the artery or thickening of the walls of the arteries.
详细描述
Primary Objective: To determine the proportion of patients with clinically significant carotid artery stenosis (≥50% stenosis) in head and neck cancer survivors treated with head and neck radiotherapy.
Secondary Objectives:
- To measure the intima-media thickness (IMT) of the carotid arteries in head and neck cancer survivors treated with head and neck radiotherapy.
- To determine the proportion of patients with carotid intima-media thickness of at least 0.9 mm in head and neck cancer survivors treated with head and neck radiotherapy.
- To determine the proportion of patients with carotid plaque of maximum thickness 2 mm or greater in head and neck cancer survivors treated with head and neck radiotherapy.
- To determine the proportion of patients identified as having a high risk of cardiovascular events (relative risk 1.50 or greater) based on intima-media thickness measurements in head and neck cancer survivors treated with head and neck radiotherapy.
- To describe the risk of significant carotid artery stenosis based on various clinical factors in head and neck cancer survivors treated with head and neck radiotherapy.
- To determine the feasibility of carotid ultrasound in head and neck cancer survivors treated with head and neck radiotherapy.
- To obtain preliminary data on the acceptability of carotid ultrasound among head and neck cancer survivors treated with head and neck radiotherapy.
- To obtain preliminary data on barriers to potential carotid ultrasound screening in head and neck cancer survivors treated with head and neck radiotherapy.
- To obtain preliminary data on stroke risk perception among head and neck cancer survivors treated with radiotherapy in head and neck cancer survivors treated with head and neck radiotherapy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of head and neck cancer treated with radiotherapy. Radiotherapy target volume(s) must have included at least one region of the neck to a total dose of at least 45 gray (Gy).
- •At least 2 years since completion of radiotherapy with no evidence of disease at the time of last clinical follow-up.
- •Eligible by Screening Questionnaire.
- •Ability to understand and the willingness to sign an IRB-approved informed consent document (either directly or via a legally authorized representative).
排除标准
- •Personal history of any of the following: Carotid artery stenosis on either side of the neck, stroke (CVA) or transient ischemic attack (TIA), carotid endarterectomy, carotid stent placement.
- •Prior carotid artery ultrasound examination between completion of radiotherapy and registration.
- •Most recent radiotherapy treatment was for any recurrence of a prior head and neck cancer and/or treatment for a subsequent head and neck cancer after diagnosis and treatment of an initial head and neck cancer.
- •Any history of re-irradiation to the head and neck region. Re-irradiation is defined as a subsequent individual course of radiotherapy where the target overlaps a region of the head/neck that was previously targeted by the initial course of radiotherapy.
- •ECOG Performance Status of 2 or greater.
结局指标
主要结局
Number of Participants with 50% Stenosis Identified
时间窗: At study completion, up to 1 approximately year
This will be defined as having a peak systolic flow velocity of 150 cm/s or higher on Doppler ultrasonography will be estimated and reported along with an exact 95% confidence interval.
次要结局
- Change in Intima-Media Thickness (IMT)(At time of ultrasound, up to approximately 1 year)
- Number of Participants with Carotid Intima-Media Thickness (IMT) Increase(At time of ultrasound, up to approximately 1 year)
- Number of Participants with Carotid Plaque Thickness Increase(At time of ultrasound, up to approximately 1 year)
- Number of Participants Identified at High Risk of Cardiovascular Events(At time of ultrasound, up to approximately 1 year)
- Number of Participants with Clinically Significant Carotid Artery Stenosis (Greater than or Equal to 50%) Based on Potential Risk Factors(At time of ultrasound, up to approximately 1 year)
- Number of Participants Enrolled that Receive Study Intervention - Feasibility(At time of enrollment, up to approximately 1 year)
- Acceptability of Intervention Measure Instrument (Likert scale).(At study completion, up to approximately 1 year)
- Barriers Survey instrument (Likert scale)(At study completion, up to approximately 1 year)
- Assessment of Risk Perception Instrument (Likert scale)(At study completion, up to approximately 1 year)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
CIMT and Plaque Assessment Findings in Subjects Undergoing Stress Echocardiography For Risk StratificationCardiovascular Risk StratificationCarotid Intima-media Thickness (CIMT)Stress Echocardiography (SE)NCT02245048Mayo Clinic73
尚未招募
不适用
Cardiovascular Ultrasound for the Rehabilitation of Patients With Coronary Heart Disease After PCICoronary Heart DiseaseNCT06640400Qilu Hospital of Shandong University200
招募中
不适用
Clinical Study of Combined Carotid Artery With Inferior Vena Cava Ultrasonography to Predict Hypotension After Induction of General AnesthesiaUltrasound GuidanceNCT05472025Tongji Hospital106
已完成
不适用
Radiation Therapy and Cardiac EnzymesTumorNCT00777751M.D. Anderson Cancer Center30
尚未招募
不适用
Role Of point of care Ultrasonographic parameters in Prediction Of Post-Spinal anesthesia Hypotension During Caesarean Delivery- A Observational StudyCTRI/2022/07/044396Dr Abhinav Agarwal