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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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25 February 2013 |
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Main ID: |
NCT01461343 |
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Date of registration:
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25/10/2011 |
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Primary sponsor: |
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Public title:
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Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Hypertension Using Positron Emission Tomography Imaging
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Scientific title:
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Evaluation of Pulmonary Perfusion Heterogeneity and Compliance in Patients With Pulmonary Arterial Hypertension Using Functional Positron Emission Tomography Imaging |
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Date of first enrolment:
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February 2013 |
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Target sample size:
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15 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01461343 |
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Study type:
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Interventional |
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Study design:
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Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
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Countries of recruitment
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United States
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Contacts
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Name:
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R. Scott Harris, M.D. |
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Address:
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Telephone:
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617-726-9429 |
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Email:
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Affiliation:
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Name:
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R. Scott Harris, M.D. |
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Address:
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Telephone:
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Email:
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Affiliation:
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Massachusetts General Hospital |
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Key inclusion & exclusion criteria
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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.
Age minimum:
18 Years
Age maximum:
70 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Exercise-Induced Pulmonary Hypertension
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Pulmonary Arterial Hypertension
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Intervention(s)
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Other: CT imaging, functional PET imaging
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Primary Outcome(s)
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Coefficient of variation of perfusion
[Time Frame: One imaging visit lasting up to 3 hours]
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Secondary Outcome(s)
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Perfusion gradient
[Time Frame: One imaging visit lasting up to 3 hours]
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Vascular compliance
[Time Frame: One imaging visit lasting up to 3 hours]
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Secondary ID(s)
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2011-P-001880/1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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