Clinical Trial News

From Staff Reports

Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III) is a multicenter, prospective study of the accuracy of gadolinium enhanced magnetic resonance angiography (Gd-MRA) of the pulmonary arteries coupled to magnetic resonance venography (MRV) of the thigh veins in diagnosing patients with clinically suspected acute pulmonary embolism. Previous studies indicated that contraindications to an imaging procedure that would expose patients to ionizing radiation or iodinated contrast material were present in more than 24% of patients with suspected acute PE. Such patients often take the risk of having these procedures because of the importance of a definitive diagnosis. Gd-MRA/MRV would be a safer alternative if it proved as reliable as standard techniques. PIOPED III will examine the accuracy of Gd-MRA/MRV in order to determine sensitivity, specificity, and likelihood ratio for positive and negative test results in 1,256 patients with suspected acute pulmonary embolism recruited at clinical centers. The study is not yet open for patient recruitment, has an expected completion date of May 2009, and is sponsored by the National Heart, Lung, and Blood Institute.

Cystic Fibrosis and Totally Implantable Vascular Access Devices is a phase IV interventional study to evaluate the incidence of venous thrombosis on the vascular access device occurring in patients who need a new device (the first or a replacement). Patients with cystic fibrosis require repeated intravenous antibiotics, often necessitating a central venous device. The risk of venous thrombosis has been evaluated as between 4% and 16%. Venous thrombosis not only can deny vascular access but may cause a pleural effusion or pulmonary embolism. The primary outcome to be evaluated is the occurrence of venous thrombosis related to the catheter as identified by ultrasonography. This study, not yet open for patient recruitment at press time, is being sponsored by the Assistance Publique-Hopitaux de Paris. Total expected enrollment is 100 patients, with an expected study conclusion of March 2008.

--From staff reports