Expired Study
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San Francisco, California 94143


Purpose:

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.


Study summary:

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.


Criteria:

Inclusion Criteria: - Adult - Pulmonary hypertension Exclusion Criteria: - Pacemaker - Renal dysfunction - Cochlear implant - Previous lung transplant


Study is Available At:


Original ID:

15-16502


NCT ID:

NCT02485977


Secondary ID:


Study Acronym:


Brief Title:

Cardiac MRI in Pulmonary Hypertension


Official Title:


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of California, San Francisco


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

1


Total Enrollment:

24


Enrollment Type:

Actual


Study Dates

Start Date:July 2015
Completion Date:June 2017
Completion Type:Actual
Primary Completion Date:June 2017
Primary Completion Type:Actual
Verification Date:December 2018
Last Changed Date:December 10, 2018
First Received Date:June 26, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:MRI scar burden measured by T1 mapping
Time Frame:1 hour
Safety Issues:False

Study Interventions

Intervention Type:Device
Name:Magnetic resonance Imaging
Description:MRI study will be performed on 1.5 Tesla magnet, during the administration of Gadolinium
Arm Name:Pulmonary Hypertension

Study Arms

Study Arm Type:Other
Arm Name:Pulmonary Hypertension
Description:Adult patients with pulmonary hypertension referred for cardiac catheterization in the PI institution

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of California, San Francisco

Samples and Retentions

Study Population: Adult patients with pulmonary hypertension referred for cardiac catheterization at UCSF
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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