Diffusion MRI in Heart Failure

Part of paid clinical trials in Charlestown, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT02973633
Phase
EARLY_PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Accepted

Interventions

  • Diffusion Tensor MRI (DTI) — DEVICE
    Diffusion Tensor MRI (DTI) measures the diffusion of water in the heart, which allows the orientation of the muscle fibers in the heart to be determined.
  • Gadolinium DOTA Meglumine — DRUG
    Late Gadolinium enhancement

Study Details

The development of symptomatic heart failure is frequently preceded by a pre-clinical period of structural remodeling in the heart. The remodeling process driving this transition, however, remains poorly understood. The investigators hypothesize that imaging the diffusion of water in the heart with MRI will allow its microstructure to be resolved. The investigators further hypothesize that the characterization of microstructural changes in the heart will help elucidate the pathogenesis of heart failure and the transition from a compensated to a decompensated state. Patients with recent myocardial infarcts and left ventricular hypertrophy, who are at risk for the development of heart failure, will be enrolled. The participants will undergo serial diffusion tensor MRI (DTI) imaging of the heart to characterize changes in myocardial microstructure over time.

Key Dates

Start date
Jun 30, 2017
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
160 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC

Arms

  • Active Comparator: Healthy Volunteers
    DTI will be performed in healthy volunteers to characterize normal fiber architecture in the heart and provide a comparison group for the patients imaged in the other arms.
  • Active Comparator: Patients with Recent Myocardial Infarction
    Patients with recent ST elevation myocardial infarcts will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with remodeling of the left ventricle.
  • Active Comparator: Patients with Left Ventricular Hypertrophy
    Patients with left ventricular hypertrophy and a history of heart failure will be recruited and imaged serially with DTI to detect changes in fiber architecture and their correlation with the onset and progression of heart failure.

Primary Outcome Measure

Myofiber Helix Angle [ Time Frame: 12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Massachusetts General HospitalCharlestownMassachusetts02129-

Find similar trials in Charlestown, MA

By condition
Heart failure
By specialty
CardiologyHeart disease
By research site
Massachusetts General Hospital· Charlestown, MA

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