New MRI Methods Applied to Heart Failure With Preserved Ejection Fraction (HFpEF)
NCT ID: NCT04600115
Last Updated: 2020-10-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
EARLY_PHASE1
100 participants
INTERVENTIONAL
2017-03-03
2023-03-03
Brief Summary
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1. To develop robust acquisition and reconstruction methods specifically for the study of microvascular cardiac remodeling with MRI which will include very innovative quantitative perfusion methods, as well as fibrosis quantification, longitudinal strain, and phase contrast imaging for flow.
2. Test the new methods for identifying the clinical task of characterizing HFpEF.
Detailed Description
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The idea of this project is to combine new techniques for quantitative cardiac perfusion MRI imaging that would be ideally suited for answering open questions regarding HFpEF and for studying microvascular disease. The methods could potentially also predict patients who might respond to particular drug therapies.
The new techniques include "simultaneous multi-slice" imaging which has not been used this way for myocardial perfusion imaging. In particular, we are developing an innovative hybrid of the standard saturation pulse and steady state spoiled gradient echo acquisitions. We also are developing a new method for using 3D "stack of stars" + 2D slice in the same scan for arterial input function assessment to quantify perfusion, and new methods for measuring T1.
Conditions
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Study Design
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NA
SINGLE_GROUP
HEALTH_SERVICES_RESEARCH
NONE
Study Groups
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MRI vs.PET with/without Cardiac disease
Adenosine Regadenoson O-15 Labeled radioactive water MRI PET Imaging
Adenosine
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
Regadenoson
0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
O-15 labeled radioactive water
O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
MRI
Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
PET Imaging
Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day
Interventions
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Adenosine
Adenosine: 0.14mg/kg/min for 6 min. IV injection for MRI perfusion
Regadenoson
0.4mg in 5ml, given as a rapid (10 seconds) IV injection for MRI perfusion.
O-15 labeled radioactive water
O-15 labeled radioactive water: Up to 50mCi IV injection at rest and again at hyperemia for PET Imaging
MRI
Pass dynamic contrast enhanced MRI scans will be performed at rest and during hyperemia caused by either adenosine infusion or regadenoson
PET Imaging
Quantitative PET imaging with O-15 labeled radioactive water will be given at a different day
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Group A (volunteers, with or without cardiac disease): Volunteers will be available for at least one study visit
* Group B (HFpEF patient volunteers): Volunteers will have a diagnosis of HFpEF and be safe to be imaged with MRI
Exclusion Criteria
* Critically ill patients, patients on ventilators, patients with unstable angina or with hypotension, asthmatics, and other patients whose medical care or safety may be at risk from undergoing an MRI examination will be excluded.
* Patients with claustrophobia will also be excluded from the study if this cannot be controlled with standard methods (valium or benadryl).
* Patients with contraindication to MRI (metal implants, or certain types of heart valves),
* pregnant patients, , mentally disabled patients and prisoners will be excluded from this study. (All criteria apply to patients and normal volunteers).
* Gadolinium nephrotoxicity will be addressed by having patients with abnormal kidney function (GFR\<30) excluded from the study due to the (very small) risk associated with gadolinium contrast agents.
* This threshold may be modified, depending on practices determined by the Radiology Department and the IRB.
* Patients with a known allergy or contraindication to Adenosine and/or Regadenoson will be excluded from stress MRI cohorts.
* All participants that will receive a stress agent will refrain from consuming caffeine for at least 12 hours prior to each MRI
* Subjects with a known contraindication to Adenosine and/or Regadenoson will only be enrolled in scans where no stress agent will be administered
18 Years
ALL
Yes
Sponsors
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National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of Utah
OTHER
Responsible Party
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Edward DiBella
Ph.D.
Principal Investigators
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Edward DiBella, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
Faculty
Locations
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university of Utah, Radiology Research
Salt Lake City, Utah, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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IRB 94980
Identifier Type: -
Identifier Source: org_study_id