Magnetic Resonance Diagnosis of Pulmonary Embolism: Prospective Evaluation in 280 Patients, With Comparison to Multi-slice CT Angiography
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- MRI studies will be interpreted at the end of the inclusion process. CTA results will serve as reference standard to evaluate MRI sensitivity, specificity, positive and negative predictive values. Inter-observer agreement will be evaluated
研究概览
简要总结
- The purpose of this study is to evaluate the diagnostic accuracy of thoracic magnetic resonance imaging with gadolinium-enhanced, unenhanced and perfusion sequences in patients with clinically suspected acute pulmonary embolism
- Thoracic CT angiography (CTA) will serve as reference standard
- Result of MRI will not interfere with patients' management
- Untreated patients with negative CTA will have 3-month follow-up to verify they were free of thrombose-embolic disease
详细描述
Background In patients with clinically suspected pulmonary embolism (PE)°with a contraindication to thoracic CT angiography, there is a need for an alternative diagnostic procedure. MRI has not been fully evaluated in this field; moreover, recent technological advances make it necessary to re-evaluate its performance for PE diagnosis.
Design Prospective monocentric study
- Patients with clinically suspected acute pulmonary embolism will undergo thoracic magnetic resonance imaging if inclusion criteria are fulfilled.
- A non-inclusion register will be establish for patients fulfilling the inclusion criteria , not included because MRI was not available (off-hours presentation , another patients already included in the protocol on the same day )
Estimated enrolment : 280 (based on a 25% prevalence of PE in our institution and an expected 80% sensitivity of MRI) Study start date: June 2007 Estimated study completion date: 17 months later (40 to 50 presentations for PE suspicion each month, 20 inclusions expected per month)
Magnetic Resonance imaging: performed on a 1.5 Tesla unit with 3 different sequences
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
- •Clinically suspected acute pulmonary embolism
- •18 years old or more
- •D-dimers more than 500 or high clinical probability of pulmonary embolism according to the revised Geneva score
- •Thoracic CT angiography performed within 24 hours
- •Informed consent
排除标准
- •- Contraindication to MRI (pace maker, claustrophobia, any implanted ferromagnetic foreign body)
- •Obese patients too large to fit in MRI unit
- •Allergy to gadolinium-containing contrast agent or to iodinated contrast media
- •Renal insufficiency (clearance less than 30 ml/mn)
- •Anticoagulation at a curative dose started more than 48 hours prior to MRI
- •Life expectancy less than 3 months
- •Pregnancy
结局指标
主要结局
MRI studies will be interpreted at the end of the inclusion process. CTA results will serve as reference standard to evaluate MRI sensitivity, specificity, positive and negative predictive values. Inter-observer agreement will be evaluated
时间窗: 17 months after the first inclusion
次要结局
- 3 months clinical follow-up will be performed in patients with negative CTA results who did not receive anticoagulation. This is to verify there were no false negatives on CTA(3 months afer CTA)