Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging
2018年3月21日 更新者：Robert Scott Harris, M.D.、Massachusetts General Hospital
Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Arterial Hypertension Using Functional Positron Emission Tomography Imaging
The purpose of the study is to find out how the blood flow changes in the lungs of people with pulmonary hypertension compared to healthy individuals without pulmonary hypertension.
We would like to find out if there are differences in how blood flows when subjects are given a drug to dilate (widen) the arteries in their lungs and when they breathe extra oxygen.
We will compare the results to when subjects don't receive any drug or extra oxygen.
We hope that knowing about these differences will help us to better understand pulmonary hypertension and how to diagnose it earlier.
調査の概要
詳細な説明
Pulmonary hypertension (PH) refers to abnormalities in the pulmonary vasculature associated with a diverse group of disorders.
The World Health Organization (WHO) classifies pulmonary hypertension into five groups, with Group I comprising pulmonary arterial hypertension (formerly referred to as "primary pulmonary hypertension").
Although not currently a part of the WHO classification, exercise-induced pulmonary arterial hypertension (EIPAH), defined by normal pulmonary artery pressures at rest and elevation of pulmonary pressures with exercise, is increasingly recognized as a distinct clinical entity.
In some patients, exercise-induced pulmonary hypertension may represent a precursor for developing an established elevation in pulmonary pressures at rest that defines PAH.
Functional PET imaging has not previously been utilized to quantify perfusion and vascular compliance in patients with pulmonary arterial hypertension.
The overall goal of this study is to evaluate regional lung perfusion, perfusion heterogeneity, and vascular compliance in patients with both exercise-induced and resting pulmonary hypertension using functional positron emission tomography imaging.
Ultimately, if quantifiable differences between healthy subjects and patients with PAH are detected with 13NN and 11CO labeled PET, functional PET imaging may provide a useful imaging modality in early diagnosis of pulmonary hypertension and monitoring response to therapy.
In this pilot study, we will recruit 10 adult patients with pulmonary hypertension (5 with PAH and 5 with EIPAH) who are on stable PAH-specific therapy (if any), and 5 healthy controls.
研究の種類
介入
入学 (実際)
16
段階
- 適用できない
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Massachusetts
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Boston、Massachusetts、アメリカ、02114
- Massachusetts General Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～70年 (大人、高齢者)
健康ボランティアの受け入れ
はい
受講資格のある性別
全て
説明
Inclusion Criteria:
General
- A signed and dated written informed consent is obtained from the subject.
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- Available to complete the study.
- Able to lie flat and able to perform a 30 second breath hold.
Patients with Pulmonary Hypertension
- Subject is male or female aged = or > 18 years of age and < or = 70 years.
- Subject is diagnosed with pulmonary arterial hypertension (WHO Group I, by right heart catheterization, mean PA pressure > 25 and PCWP < 15) or exercise-induced pulmonary hypertension (by right heart catheterization + Level III cardiopulmonary exercise testing, mean PAP > 30 and PCWP < 20 during exercise, but normal at rest), with the most recent of above diagnostic tests taking place within 12 months of study entry.
- If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least 3 months.
Exclusion Criteria:
General
- FEV1 and/or TLC < 70% predicted
- PCWP > 15 mm Hg
- Inability to perform the study (by primary MD or investigator assessment)
- Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study
- The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
- The subject has a positive pregnancy test.
- The subject is unable to perform the respiratory manoeuvres necessary for the exam.
- The subject has been exposed to a radiation dose over the past year that, when added to the radiation dose expected in this study, would exceed permissible yearly exposure as determined by the MGH radiation safety committee.
Subjects with Pulmonary Hypertension
- Subject with clinical instability in the judgment of the investigator, or hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
- Subjects in whom PAH therapy has been escalated (additional agent started) within 3 months of enrolment.
- Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, or COPD.
- Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：他の
- 割り当て：非ランダム化
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：pulmonary hypertension
Patients with Group I pulmonary arterial hypertension and exercise-induced pulmonary hypertension to undergo CT imaging, functional PET imaging
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Physiology study using CT and functional PET imaging with 13NN and 11CO as radiotracers; images obtained before and after administration of inhaled nitric oxide and balance 80% oxygen as pulmonary vasodilators
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アクティブコンパレータ：healthy controls
healthy adults to serve as controls and to undergo the same study procedures: CT imaging, functional PET imaging
|
Physiology study using CT and functional PET imaging with 13NN and 11CO as radiotracers; images obtained before and after administration of inhaled nitric oxide and balance 80% oxygen as pulmonary vasodilators
|
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 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Coefficient of variation of perfusion
時間枠：One imaging visit lasting up to 3 hours
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Images will be generated with positron emission tomography that will be used to calculate the degreee to which the blood flow in the lung is patchy rather than smooth.
The statistical measure of this is called the coefficient of variation.
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One imaging visit lasting up to 3 hours
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Vascular compliance
時間枠：One imaging visit lasting up to 3 hours
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Positron emission tomography images will be obtained during different phases of the heart beat that will show how the blood vessels in the lung stretch with ejection of blood from the heart.
The change in volume of the blood vessels is called vascular compliance and is a measure of blood vessel stiffness.
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One imaging visit lasting up to 3 hours
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Perfusion gradient
時間枠：One imaging visit lasting up to 3 hours
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From the images of blood flow in the lung, the change in mean blood flow from the bottom of the lung to the top will be calculated.
Normally, there is more blood flow at the bottom of the lung compared to the top, but this can be changed with lung disease.
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One imaging visit lasting up to 3 hours
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：R. Scott Harris, M.D.、Massachusetts General Hospital
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2013年2月1日
一次修了 (実際)
2017年11月21日
研究の完了 (実際)
2018年3月15日
試験登録日
最初に提出
2011年10月25日
QC基準を満たした最初の提出物
2011年10月26日
最初の投稿 (見積もり)
2011年10月28日
学習記録の更新
投稿された最後の更新 (実際)
2018年3月23日
QC基準を満たした最後の更新が送信されました
2018年3月21日
最終確認日
2018年3月1日
詳しくは
本研究に関する用語
その他の研究ID番号
- 2011-P-001880/1
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。