Clinical Value of CT Perfusion in Peripheral Artery Disease (iPAD)
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.
研究概览
地位
条件
研究类型
注册 (估计的)
参与标准
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
取样方法
研究人群
描述
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
学习计划
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Predictive value of CT perfusion for adverse clinical events after revascularization
大体时间：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.
|
From baseline (preoperative) assessment through 2 years after revascularization
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (估计的)
初级完成 (估计的)
研究完成 (估计的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.