Validating Cardiac MRI Biomarkers and Genotype-Phenotype Correlations for DMD
NCT ID: NCT02834650
Last Updated: 2022-05-10
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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COMPLETED
NA
89 participants
INTERVENTIONAL
2017-02-01
2022-03-30
Brief Summary
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Currently, there is a lack of sufficiently well characterized cardiac MRI biomarkers that can serve as endpoints for detecting on-target and/or off-target cardiac effects during clinical drug trials for boys with DMD.
Consequently, the first objective is to identify and characterize several cardiac MRI biomarkers for boys with DMD.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
BASIC_SCIENCE
NONE
Study Groups
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Group 1a
Group 1a comprises healthy volunteers who will complete a Cardiac MRI without contrast. A subset of healthy volunteers will have a repeat MRI at Children's Hospital of Orange County.
Cardiac MRI without contrast
Cardiac MRI
Repeat MRI scan
Repeat MRI scan
Group 1b
Group 1b comprises boys with DMD who will complete a Cardiac MRI with contrast, a blood test, a heart rate test and a pulmonary function test.
A subset of boys with DMD will have a repeat MRI with contrast at Children's Hospital of Orange County.
Cardiac MRI with contrast
Cardiac MRI
Blood Test
Hematocrit, Creatinine, Troponin, BNP
Heart Rate
Holter Monitor
Pulmonary Function Test
Pulmonary Function Test
Genetic Testing
Genetic Testing
Repeat MRI scan
Repeat MRI scan
Group 2
Group 2 comprises boys with DMD who will complete a Cardiac MRI with contrast, a blood test, a heart rate test and a pulmonary function test and a repeat MRI scan with contrast at 6 Months.
Cardiac MRI with contrast
Cardiac MRI
Blood Test
Hematocrit, Creatinine, Troponin, BNP
Heart Rate
Holter Monitor
Pulmonary Function Test
Pulmonary Function Test
Genetic Testing
Genetic Testing
Repeat MRI scan
Repeat MRI scan
Group 3
Group 3 comprises boys with DMD who will complete a Cardiac MRI with contrast, a blood test, a heart rate test and a pulmonary function test and a genetic testing.
Cardiac MRI with contrast
Cardiac MRI
Blood Test
Hematocrit, Creatinine, Troponin, BNP
Heart Rate
Holter Monitor
Pulmonary Function Test
Pulmonary Function Test
Genetic Testing
Genetic Testing
Interventions
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Cardiac MRI with contrast
Cardiac MRI
Cardiac MRI without contrast
Cardiac MRI
Blood Test
Hematocrit, Creatinine, Troponin, BNP
Heart Rate
Holter Monitor
Pulmonary Function Test
Pulmonary Function Test
Genetic Testing
Genetic Testing
Repeat MRI scan
Repeat MRI scan
Eligibility Criteria
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Inclusion Criteria
* Able \& willing to complete an approximately 75-minute (or less) MRI exam without sedation or mechanical ventilation
* Drug regimen (if applicable) stable for at least 3 months prior to participation
Exclusion Criteria
* Non-MRI compatible implants (e.g. neurostimulator, pacemaker, implanted cardioverter defibrillator)
* Claustrophobia that prevents an MRI exam
* Known allergy to MRI contrast agents
* Serum potassium level of \>5.0 mmol/L
* Signs and symptoms of heart failure
7 Years
21 Years
MALE
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Children's Hospital of Orange County
OTHER
National Heart, Lung, and Blood Institute (NHLBI)
NIH
University of California, Los Angeles
OTHER
Stanford University
OTHER
Responsible Party
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Daniel Ennis
Principal Investigator
Principal Investigators
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Daniel Ennis, PhD
Role: PRINCIPAL_INVESTIGATOR
Stanford University
Locations
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University of California, Los Angeles
Los Angeles, California, United States
Children's Hospital of Orange County
Orange, California, United States
Stanford University
Stanford, California, United States
Countries
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Other Identifiers
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DMD2016
Identifier Type: -
Identifier Source: org_study_id
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