- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT00241826
Prospective Investigation of Pulmonary Embolism Diagnosis III
Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Description détaillée
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:
PIOPED III is a multicenter prospective investigation designed to determine the diagnostic accuracy of Gd-MRA of the pulmonary arteries in combination with MRV of the veins of the thighs in patients with clinically suspected acute PE. The diagnostic accuracy of Gd-MRA alone and in combination with MRV will be expressed as sensitivity, specificity, and likelihood ratio for positive and negative tests. The study design is a prospective study of consecutive patients incorporating standardized inclusion/exclusion criteria, complete ascertainment of patient characteristics and outcomes, uniform diagnostic criteria, and unbiased paired central readings of imaging studies. Over a period of 2 years, 1,256 patients with suspected acute PE will be recruited at clinical centers. Composite reference standards will be used to diagnose venous thromboembolism (VTE) and exclude PE. It is expected that 314 patients will have acute VTE and they will undergo Gd-MRA/MRV. It is expected that 942 patients will be shown not to have PE. From among this group, 314 patients will be randomly selected for the index test, Gd-MRA/MRV.
Type d'étude
Inscription (Anticipé)
Contacts et emplacements
Lieux d'étude
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Alberta
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Calgary, Alberta, Canada, T2N 2T9
- Foothills Hospital
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Georgia
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Atlanta, Georgia, États-Unis, 30308
- Emory University
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Maryland
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Bethesda, Maryland, États-Unis, 20892
- Divison of Lung Diseases, NHLBI
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Rockville, Maryland, États-Unis, 20852
- Data Coordinating Center
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Massachusetts
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Boston, Massachusetts, États-Unis, 02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor, Michigan, États-Unis, 48109
- University of Michigan Medical Center
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Pontiac, Michigan, États-Unis, 48341
- St. Joseph Mercy-Oakland
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Missouri
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St. Louis, Missouri, États-Unis, 63110
- Washington University Medical Center
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New York
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New York, New York, États-Unis, 10016
- NYU Medical Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
Inclusion Criteria:
- Acute PE of diagnostic concern
- Informed consent
- Willing to undergo Gd-MRA/MRV
Exclusion Criteria:
- 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
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Délai |
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Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard
Délai: Measured within 36 to 48 hours of study entry
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Measured within 36 to 48 hours of study entry
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Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Sarah Fowler, PhD, George Washington University
- Chercheur principal: Charles Hales, MD, Massachusetts General Hospital
- Chercheur principal: Russell Hull, MBBS, MSc, University of Calgary
- Chercheur principal: Kenneth Leeper, Jr., MD, Emory University
- Chercheur principal: David Naidich, MD, NYU Langone Health
- Chercheur principal: Daniel Sak, Do, St. Joseph Mercy Oakland
- Chaise d'étude: Paul D. Stein, MD, St. Joseph Mercy Oakland
- Chercheur principal: John Weg, MD, University of Michigan at Ann Arbor
- Chercheur principal: Pamela Woodard, MD, Washington University School of Medicine
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- 329
- U01HL077155 (Subvention/contrat des NIH des États-Unis)
- U01HL077149 (Subvention/contrat des NIH des États-Unis)
- U01HL077150 (Subvention/contrat des NIH des États-Unis)
- U01HL077151 (Subvention/contrat des NIH des États-Unis)
- U01HL077153 (Subvention/contrat des NIH des États-Unis)
- U01HL077154 (Subvention/contrat des NIH des États-Unis)
- U01HL077358 (Subvention/contrat des NIH des États-Unis)
- U01HL081593 (Subvention/contrat des NIH des États-Unis)
- U01HL081594 (Subvention/contrat des NIH des États-Unis)
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