Chronic Thromboembolic Pulmonary HypertensionNCT02114047
Pulmonary Perfusion Heterogeneity in Patients With CTEPH Using Functional PET Imaging
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
This study with evaluate blood flow in the lungs of patients prior to and after surgery for treatment. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Thromboembolic Pulmonary Hypertension
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Chronic thromboembolic pulmonary hypertension
Who may be able to join
- Subject is diagnosed with chronic thromboembolic pulmonary hypertension (WHO Group IV) and planning to undergo pulmonary thromboendarterectomy.
- Subject is male or female aged > or =18 years of age and < or = 70 years.
- Subject has undergone RHC within six months of entering the study.
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- A signed and dated written informed consent is obtained from the subject.
- Available to complete the study.
- Able to lie flat and able to perform a 30 second breath hold.
Who cannot join
- FEV1 and/or TLC < 70% predicted.
- Inability to perform the study (by primary MD or investigator assessment).
- Inability to perform the respiratory maneuvers necessary for the exam.
- 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 is a woman of childbearing potential who is pregnant, seeking to become pregnant, or has a positive pregnancy test.
Show all 10Show fewer
- Subject with clinical instability in the judgment of the investigator, with a heart rate > 120 bpm, respiratory rate > 24, SpO2 < 88%, blood pressure < 90/60 or > 140/90 or fever > 101, or subjects with hospitalization for progression of pulmonary hypertension or right heart failure in the three months prior to the study.
- Subject with diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, asthma, heart failure, ischemic heart disease, 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.
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
Official title: Evaluation of Pulmonary Perfusion Heterogeneity in Patients With Chronic Thromboembolic Pulmonary Hypertension Using Functional PET Imaging
This study with evaluate blood flow in the lungs of patients prior to and after surgery for treatment.
Read the detailed description
Specifically, we will evaluate the length-scale or size of blood flow alterations using filtering techniques with the objective of identifying the size of blood vessels that are obstructed by clot (large vessels versus small vessels).
What is being measured
The primary outcome is the main question the study is designed to answer.
perfusion heterogeneity
We will use a method to analyze the length-scale of perfusion heterogeneity before and after surgery for CTEPH. Briefly, this method consists of filtering the images with filters of different spatial size (length, mm) and measuring the coefficient of variation (CV) of perfusion in the imaged field. We then bin the CV into the following intervals: 12-36 mm, 36-60 mm, 60-84 mm, 84-108 mm and >108 mm and compare the CV in each bin among subjects.
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startFeb 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Thromboembolic Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Robert Scott Harris, M.D., Massachusetts General Hospital
- Investigators
- Robert S Harris, MD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114047
- Sponsor's protocol ID
- 2013D002300
- Status last verified
- Mar 2017
- First submitted
- 2 Apr 2014
- Last updated
- 23 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: Since imaging data can be identifying, researchers will need to write to the investigators and submit to IRB review if they would like to obtain raw imaging data.
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Pulmonary Perfusion Heterogeneity in Patients With Chronic Thromboembolic Pulmonary Hypertension Using Functional PET Imaging
- ClinicalTrials.gov ID
- NCT02114047
- Acronym / sponsor ID
- 2013D002300
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study with evaluate blood flow in the lungs of patients prior to and after surgery for treatment.
Detailed description
Specifically, we will evaluate the length-scale or size of blood flow alterations using filtering techniques with the objective of identifying the size of blood vessels that are obstructed by clot (large vessels versus small vessels).
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Chronic thromboembolic pulmonary hypertension
Key inclusion criteria (7 listed)
- Subject is diagnosed with chronic thromboembolic pulmonary hypertension (WHO Group IV) and planning to undergo pulmonary thromboendarterectomy.
- Subject is male or female aged > or =18 years of age and < or = 70 years.
- Subject has undergone RHC within six months of entering the study.
- The subject is capable of giving informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
- A signed and dated written informed consent is obtained from the subject.
Key exclusion criteria (10 listed)
- FEV1 and/or TLC < 70% predicted.
- Inability to perform the study (by primary MD or investigator assessment).
- Inability to perform the respiratory maneuvers necessary for the exam.
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
perfusion heterogeneity
Time frame: 4 months
We will use a method to analyze the length-scale of perfusion heterogeneity before and after surgery for CTEPH. Briefly, this method consists of filtering the images with filters of different spatial size (length, mm) and measuring the coefficient of variation (CV) of perfusion in the imaged field. We then bin the CV into the following intervals: 12-36 mm, 36-60 mm, 60-84 mm, 84-108 mm and >108 mm and compare the CV in each bin among subjects.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2017.
- Individual participant dataSharing planned: No. Since imaging data can be identifying, researchers will need to write to the investigators and submit to IRB review if they would like to obtain raw imaging data.
Related trials for Chronic Thromboembolic Pulmonary Hypertension
RecruitingPhase 3
A Study Providing Treatment Access in Participants With Pulmonary Hypertension Completing a Parent Study and Having no Other Option
Hypertension, Pulmonary
Recruiting
Vasopressor Agents in Pulmonary Hypertension Crisis
Pulmonary Arterial Hypertension (PAH), Chronic Thromboembolic Pulmonary Hypertension (CTEPH)
Not yet recruiting
CTEPH Differential Diagnosis Assisted by Enhanced Large Language Model Support
Chronic Thromboembolic Pulmonary Hypertension (CTEPH), Acute Pulmonary Embolism (PE)
Active, not recruitingObservational study
TrEatment Approach in the Multimodal Era Registry
Chronic Thromboembolic Pulmonary Hypertension, CTEPH
RecruitingObservational study
Pulmonary Embolism Registry From Short-Term Emergency to Long-Term Follow-Up and Surveillance
Venous Thromboembolism (VTE), Chronic Thromboembolic Pulmonary Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert S Harris, MD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Thromboembolic Pulmonary Hypertension, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Mar 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
perfusion heterogeneity (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Mar 2017.