Pulmonary HypertensionNCT02485977
Cardiac MRI in Pulmonary Hypertension
An observational study of Pulmonary Hypertension, run by University of California, San Francisco at 1 site in United States.
Trial summary
The overall goal of this study is to evaluate agreement between cardiac MR parameters and well-established clinical and catheterization parameters of poor prognosis in patients with pulmonary hypertension. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Hypertension
- What is being tested?
- Magnetic resonance Imaging
- Type of treatment
- Medical device
- How many people
- 24 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Jun 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with pulmonary hypertension referred for cardiac catheterization at UCSF
Who may be able to join
- Adult
- Pulmonary hypertension
Who cannot join
- Pacemaker
- Renal dysfunction
- Cochlear implant
- Previous lung transplant
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Medical Center
San Francisco, California, 94143
About this study
The overall goal of this study is to evaluate agreement between cardiac MR parameters and well-established clinical and catheterization parameters of poor prognosis in patients with pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate myocardial disease in patients with pulmonary hypertension would be beneficial to society due to the potential to replace serial invasive cardiac catheterization procedures with a noninvasive imaging test.
Read the detailed description
1 BACKGROUND Currently the gold standard for evaluation of pulmonary hypertension is right heart pressure as measured by cardiac catheterization. Thus the method for stratifying patients with pulmonary hypertension in terms of risk and response to treatment is suboptimal, requiring multiple invasive procedures.
A number of studies have suggested that cardiac MR imaging is useful in the diagnosis of myocardial disease and may be related to patient prognosis in both ischemic and non-ischemic cardiomyopathy. Patients with pulmonary hypertension demonstrate post gadolinium delayed enhancement at the points of insertion of the right ventricle onto the inter-ventricular septum, and the presence of this finding has been shown to be inversely correlated with right ventricular function.
Quantitative evaluation of extracellular volume by post-gadolinium T1 relaxation time mapping (T1 mapping) and extracellular volume (ECV) mapping is used to quantify the extent of myocardial fibrosis, can detect fibrosis earlier than delayed enhancement imaging, and is particularly useful in non-ischemic or diffuse myocardial diseases. In addition, Displacement Encoding with Stimulated Echoes (DENSE) is a technique that allows quantification of tissue motion and myocardial strain, which can identify early myocardial dysfunction in patients with preserved ejection fraction, and therefore may be useful in the evaluation of myocardial function in pulmonary hypertension.
Utilization of novel cardiac MR techniques for quantitative assessment of the extent of subclinical myocardial disease in patients with pulmonary hypertension may therefore serve as a non-invasive tool to inform prognosis and surrogate biomarker to evaluate effectiveness of treatment strategies, with the potential to replace serial cardiac catheterization in these patients.
Our hypothesis is that utilization of novel cardiac MR techniques for quantitative assessment of the extent of subclinical myocardial disease in patients with pulmonary hypertension may serve as a non-invasive tool to inform prognosis and surrogate biomarker to evaluate effectiveness of treatment strategies, with the potential to replace serial cardiac catheterization in these patients.
Adult patients with pulmonary hypertension under clinical care at the UCSF pulmonary hypertension clinic who are referred for right heart catheterization will be invited to participate in our study. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Each participant will undergo cardiac MR examination during a single one-hour study visit.
- Conditions
- Pulmonary Hypertension
- Being tested
- Magnetic resonance Imaging
- Keywords
- Pulmonary hypertension, Magnetic Resonance Imaging
- Medical subject headings
- Hypertension, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic resonance ImagingDevice
MRI study will be performed on 1.5 Tesla magnet, during the administration of Gadolinium
| Study group | Role | What they receive |
|---|---|---|
| Pulmonary Hypertension | Adult patients with pulmonary hypertension referred for cardiac catheterization in the PI institution Receives: Device: Magnetic resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
MRI scar burden measured by T1 mapping
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionJun 2017
- Study completionJun 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary HypertensionStudies of the same condition, open and under way.
- More trials run by University of California, San FranciscoThe 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
- Cross-sectional
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, San Francisco
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02485977
- Sponsor's protocol ID
- 15-16502
- Status last verified
- Dec 2018
- First submitted
- 26 Jun 2015
- Last updated
- 12 Dec 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cardiac MRI in Pulmonary Hypertension
- ClinicalTrials.gov ID
- NCT02485977
- Acronym / sponsor ID
- 15-16502
- Conditions
- Pulmonary Hypertension
- Keywords
- Pulmonary hypertension, Magnetic Resonance Imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- University of California, San FranciscoUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Jun 2017 (actual)
- Study completion
- Jun 2017 (actual)
- First posted
- 30 Jun 2015 (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.
The overall goal of this study is to evaluate agreement between cardiac MR parameters and well-established clinical and catheterization parameters of poor prognosis in patients with pulmonary hypertension. The identification of noninvasive cardiac MR techniques to evaluate myocardial disease in patients with pulmonary hypertension would be beneficial to society due to the potential to replace serial invasive cardiac catheterization procedures with a noninvasive imaging test.
Detailed description
1 BACKGROUND Currently the gold standard for evaluation of pulmonary hypertension is right heart pressure as measured by cardiac catheterization. Thus the method for stratifying patients with pulmonary hypertension in terms of risk and response to treatment is suboptimal, requiring multiple invasive procedures.
A number of studies have suggested that cardiac MR imaging is useful in the diagnosis of myocardial disease and may be related to patient prognosis in both ischemic and non-ischemic cardiomyopathy. Patients with pulmonary hypertension demonstrate post gadolinium delayed enhancement at the points of insertion of the right ventricle onto the inter-ventricular septum, and the presence of this finding has been shown to be inversely correlated with right ventricular function.
Quantitative evaluation of extracellular volume by post-gadolinium T1 relaxation time mapping (T1 mapping) and extracellular volume (ECV) mapping is used to quantify the extent of myocardial fibrosis, can detect fibrosis earlier than delayed enhancement imaging, and is particularly useful in non-ischemic or diffuse myocardial diseases. In addition, Displacement Encoding with Stimulated Echoes (DENSE) is a technique that allows quantification of tissue motion and myocardial strain, which can identify early myocardial dysfunction in patients with preserved ejection fraction, and therefore may be useful in the evaluation of myocardial function in pulmonary hypertension.
Utilization of novel cardiac MR techniques for quantitative assessment of the extent of subclinical myocardial disease in patients with pulmonary hypertension may therefore serve as a non-invasive tool to inform prognosis and surrogate biomarker to evaluate effectiveness of treatment strategies, with the potential to replace serial cardiac catheterization in these patients.
Our hypothesis is that utilization of novel cardiac MR techniques for quantitative assessment of the extent of subclinical myocardial disease in patients with pulmonary hypertension may serve as a non-invasive tool to inform prognosis and surrogate biomarker to evaluate effectiveness of treatment strategies, with the potential to replace serial cardiac catheterization in these patients.
Adult patients with pulmonary hypertension under clinical care at the UCSF pulmonary hypertension clinic who are referred for right heart catheterization will be invited to participate in our study. Screening data will be reviewed to determine subject eligibility. Subjects who meet all inclusion criteria and none of the exclusion criteria will be entered into the study. Each participant will undergo cardiac MR examination during a single one-hour study visit.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pulmonary Hypertension | – | Device: Magnetic resonance ImagingAdult patients with pulmonary hypertension referred for cardiac catheterization in the PI institution |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with pulmonary hypertension referred for cardiac catheterization at UCSF
Key inclusion criteria (2 listed)
- Adult
- Pulmonary hypertension
Key exclusion criteria (4 listed)
- Pacemaker
- Renal dysfunction
- Cochlear implant
- Previous lung transplant
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic resonance ImagingMRI study will be performed on 1.5 Tesla magnet, during the administration of Gadolinium | Device | Pulmonary Hypertension |
Primary outcome
MRI scar burden measured by T1 mapping
Time frame: 1 hour
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 12 Dec 2018.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Pulmonary Hypertension, run by University of California, San Francisco 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 2 inclusion and 4 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 12 Dec 2018. 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?
MRI scar burden measured by T1 mapping (time frame: 1 hour). 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 12 Dec 2018.