Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,256
- 试验地点
- 9
- 主要终点
- Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard
研究概览
简要总结
The purpose of this study is to determine the diagnostic accuracy of gadolinium-enhanced magnetic resonance angiography (Gd-MRA) of the pulmonary arteries in combination with magnetic resonance venography (MRV) of the veins of the thighs in patients with clinically suspected acute pulmonary embolism (PE).
详细描述
BACKGROUND:
Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III) follows PIOPED I and PIOPED II. PIOPED I was a multicenter trial supported between 1983 and 1989 to evaluate the sensitivity and specificity of two major, widely used technologies, radionuclear imaging (ventilation-perfusion scanning) and pulmonary angiography, for the diagnosis of PE. PIOPED II was a multicenter trial conducted between 2000 and 2005 to determine the value of contrast-enhanced spiral computed tomography (spiral CT) for the diagnosis of acute PE.
In PIOPED II, among 7,284 patients with suspected acute PE, 18.6% had an elevated creatinine, 3.9% were allergic to iodinated contrast material, and 4.7% of women were pregnant. One or more of these relative contraindications to an imaging procedure that would expose the patient to ionizing radiation or iodinated contrast material was present in 24.4% of patients with suspected acute PE. Although patients with relative contraindications often take the risk of CT or digital subtraction angiography (DSA) because of the importance of having a definitive diagnosis, such patients could benefit from safer diagnostic testing with Gd-MRA/MRV if it is shown to be sufficiently accurate.
The purpose of this investigation is to determine the extent to which Gd-MRA/MRV can serve as a diagnostic test in patients with clinically suspected PE and thereby eliminate the need for iodinated contrast material or ionizing radiation in patients who have a relative contraindication to one of them. This is important because 24% of patients with suspected acute PE have a relative contraindication to diagnostic procedures that involve ionizing radiation or iodinated contrast material.
DESIGN NARRATIVE:
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
- •Acute PE of diagnostic concern
- •Informed consent
- •Willing to undergo Gd-MRA/MRV
排除标准
- •Any implanted ferromagnetic foreign body, including a ferromagnetic cerebral aneurysm clip or implanted electrical device/pump
- •Dependency on a continuous connection to an external electrical device/pump (e.g., pacemaker, internal defibrillator, cochlear implant, nerve or bone stimulator implant, ICU appliance) and cardiac pacing wires
- •Severe claustrophobia
- •Severe shaking
- •Inability to lie still for 30 minutes
- •Pregnancy and nursing mothers
- •Serum creatinine levels within range of normal at local center
- •Sickle cell anemia, other hemoglobinopathies, and other hemolytic anemias
- •Critical illness, shock or hypotension, hemodynamic instability, ventilatory support, chronic anticoagulation, inferior vena cava filter
- •Documented episodes of ventricular fibrillation or sustained ventricular tachycardia within the past 24 hours
- •Myocardial infarction within the past month
- •History of allergy to gadolinium-containing contrast agents or to iodinated contrast media
- •Current symptomatic asthma
- •Clinical evidence of venous thrombosis of the upper extremity
- •Prisoners
- •Institutionalized or mentally handicapped patients
- •Too large to fit in MRI unit
结局指标
主要结局
Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard
时间窗: Measured within 36 to 48 hours of study entry
次要结局
未报告次要终点