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Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging

2018년 3월 21일 업데이트: 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.

연구 개요

상태

완전한

정황

개입 / 치료

상세 설명

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.

연구 유형

중재적

등록 (실제)

16

단계

  • 해당 없음

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 장소

  • 미국
    • Massachusetts
      • Boston, Massachusetts, 미국, 02114
        • Massachusetts General hospital

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

18년 (성인, 고령자)

건강한 자원 봉사자를 받아들입니다

예

연구 대상 성별

모두

설명

Inclusion Criteria:

  • General

    1. A signed and dated written informed consent is obtained from the subject.
    2. The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
    3. Available to complete the study.
    4. Able to lie flat and able to perform a 30 second breath hold.

  • Patients with Pulmonary Hypertension

    1. Subject is male or female aged = or > 18 years of age and < or = 70 years.
    2. 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.
    3. If patient has been on PAH-specific therapy, the therapy (agent and dose) has been unchanged for at least 3 months.

Exclusion Criteria:

  • General

    1. FEV1 and/or TLC < 70% predicted
    2. PCWP > 15 mm Hg
    3. Inability to perform the study (by primary MD or investigator assessment)
    4. Subjects who have a past or present disease, which as judged by the Investigators may affect the outcome of this study
    5. The subject has suspected history of drugs or alcohol abuse within the six months prior to the screening visit.
    6. The subject has a positive pregnancy test.
    7. The subject is unable to perform the respiratory manoeuvres necessary for the exam.
    8. 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

    1. 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.
    2. Subjects in whom PAH therapy has been escalated (additional agent started) within 3 months of enrolment.
    3. Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, or COPD.
    4. Subject that had a respiratory tract infection in the 4 weeks prior to the screening visit and throughout the duration of the study.

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 다른
  • 할당: 무작위화되지 않음
  • 중재 모델: 병렬 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: pulmonary hypertension
Patients with Group I pulmonary arterial hypertension and exercise-induced pulmonary hypertension to undergo CT imaging, functional PET imaging
다른: 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
활성 비교기: healthy controls
healthy adults to serve as controls and to undergo the same study procedures: CT imaging, functional PET imaging
다른: 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

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Coefficient of variation of perfusion
기간: One imaging visit lasting up to 3 hours
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.
One imaging visit lasting up to 3 hours

2차 결과 측정

결과 측정
측정값 설명
기간
Vascular compliance
기간: One imaging visit lasting up to 3 hours
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.
One imaging visit lasting up to 3 hours
Perfusion gradient
기간: One imaging visit lasting up to 3 hours
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.
One imaging visit lasting up to 3 hours

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Massachusetts General Hospital

수사관

  • 수석 연구원: R. Scott Harris, M.D., Massachusetts General hospital

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작

2013년 2월 1일

기본 완료 (실제)

2017년 11월 21일

연구 완료 (실제)

2018년 3월 15일

연구 등록 날짜

최초 제출

2011년 10월 25일

QC 기준을 충족하는 최초 제출

2011년 10월 26일

처음 게시됨 (추정)

2011년 10월 28일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2018년 3월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2018년 3월 21일

마지막으로 확인됨

2018년 3월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2011-P-001880/1

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

폐동맥 고혈압에 대한 임상 시험

CT imaging, functional PET imaging에 대한 임상 시험

유사한 임상시험 검색

스폰서 및 공동 작업자

건강 상태

약물 개입

CROs by country

CROs in Russia

정황

희귀 질병

약물 개입

식이 보충제

스폰서 / 협력자

위치

3
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