Clinical Value of CT Perfusion in Peripheral Artery Disease
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Predictive value of CT perfusion for adverse clinical events after revascularization
研究概览
简要总结
Peripheral artery disease (PAD) affects millions worldwide and can lead to serious complications such as leg ulcers, gangrene, and amputation. Current imaging methods mainly evaluate large blood vessels but do not measure microcirculation in the foot. Computed tomography perfusion (CTP) is a new technique that can assess blood flow in small vessels.
The purpose of this study is to see whether combining CTP measurements with standard CT angiography images and patient clinical information can help predict which PAD patients are more likely to have poor outcomes after surgery to restore blood flow (revascularization). Poor outcomes include death or major limb problems such as amputation or need for another procedure.
This is an observational study. Researchers will collect data from about 200 adult PAD patients who are scheduled to undergo revascularization. Participants will receive routine care including CT scans before and after surgery. No experimental drugs or devices are given. Researchers will follow participants for up to 2 years after surgery through medical records and phone calls to track their recovery and any complications.
The results may help doctors identify high-risk patients earlier and improve treatment decisions.
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
- •Diagnosis of peripheral artery disease (PAD) confirmed by clinical evaluation and imaging (e.g., CTA, DSA).
- •Planned to undergo endovascular or surgical revascularization.
- •Age ≥ 18 years old.
- •Signed written informed consent.
排除标准
- •Allergy to iodinated contrast agents.
- •Severe renal insufficiency (e.g., eGFR < 30 mL/min/1.73m²).
- •Acute limb ischemia requiring emergency surgery.
- •Major limb amputation already performed prior to enrollment.
- •Life expectancy less than 2 years due to severe comorbidities.
- •Unwilling or unable to complete the 2-year follow-up.
结局指标
主要结局
Predictive value of CT perfusion for adverse clinical events after revascularization
时间窗: From baseline (preoperative) assessment through 2 years after revascularization
Assessment of the predictive value of computed tomography perfusion (CTP) parameters combined with CT angiography and clinical data for postoperative adverse outcomes. Adverse clinical events are defined as all-cause mortality, major adverse limb events (including major amputation and target limb reintervention), or non-healing ulcers/gangrene. Data will be collected through medical records and follow-up visits.
次要结局
未报告次要终点
研究者
Zhijun Bao
Head of Huadong Hospital
Fudan University