Prospective Investigation of Pulmonary Embolism Diagnosis III
Prospective Investigation of Pulmonary Embolism Diagnosis III (PIOPED III)
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Georgia
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Atlanta、Georgia、アメリカ、30308
- Emory University
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Maryland
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Bethesda、Maryland、アメリカ、20892
- Divison of Lung Diseases, NHLBI
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Rockville、Maryland、アメリカ、20852
- Data Coordinating Center
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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Michigan
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Ann Arbor、Michigan、アメリカ、48109
- University of Michigan Medical Center
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Pontiac、Michigan、アメリカ、48341
- St. Joseph Mercy-Oakland
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Missouri
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St. Louis、Missouri、アメリカ、63110
- Washington University Medical Center
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New York
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New York、New York、アメリカ、10016
- NYU Medical Center
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Alberta
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Calgary、Alberta、カナダ、T2N 2T9
- Foothills Hospital
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか?
デザインの詳細
- 観測モデル:コホート
- 時間の展望:見込みのある
この研究は何を測定していますか?
主要な結果の測定
結果測定 |
時間枠 |
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Diagnosis or exclusion of pulmonary embolism in agreement with a reference standard
時間枠: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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協力者と研究者
捜査官
- 主任研究者:Sarah Fowler, PhD、George Washington University
- 主任研究者:Charles Hales, MD、Massachusetts General Hospital
- 主任研究者:Russell Hull, MBBS, MSc、University of Calgary
- 主任研究者:Kenneth Leeper, Jr., MD、Emory University
- 主任研究者:David Naidich, MD、NYU Langone Health
- 主任研究者:Daniel Sak, Do、St. Joseph Mercy Oakland
- スタディチェア:Paul D. Stein, MD、St. Joseph Mercy Oakland
- 主任研究者:John Weg, MD、University of Michigan at Ann Arbor
- 主任研究者:Pamela Woodard, MD、Washington University School of Medicine
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (見積もり)
学習記録の更新
投稿された最後の更新 (見積もり)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
その他の研究ID番号
- 329
- U01HL077155 (米国 NIH グラント/契約)
- U01HL077149 (米国 NIH グラント/契約)
- U01HL077150 (米国 NIH グラント/契約)
- U01HL077151 (米国 NIH グラント/契約)
- U01HL077153 (米国 NIH グラント/契約)
- U01HL077154 (米国 NIH グラント/契約)
- U01HL077358 (米国 NIH グラント/契約)
- U01HL081593 (米国 NIH グラント/契約)
- U01HL081594 (米国 NIH グラント/契約)
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
Magnetic Resonance Angiographyの臨床試験
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Germans Trias i Pujol Hospital完了虚血性脳卒中 | 磁気共鳴画像 | 動脈閉塞 | CTSスペイン
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Duke UniversityUniversity of Pennsylvania; National Institutes of Health (NIH)まだ募集していません
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Johns Hopkins UniversityUniversity of Texas at Austin; Baszucki Brain Research Fund; Magnus Medical完了
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Johns Hopkins UniversityNational Eye Institute (NEI)募集
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Instituto de Investigación Hospital Universitario...完了
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Ospedale della Misericordiaわからない