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Purpose

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.

Conditions

Eligibility

Eligible Ages
Between 18 Years and 85 Years
Eligible Genders
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Healthy adults with no history of hypertension, diabetes or heart disease - Patients with ST Elevation MI within last 6-10 weeks who are angina free, and have been seen by a cardiologist since discharge - Patients with episode of heart failure within last 12 months and left ventricular hypertrophy, documented by echocardiogram or MRI.

Exclusion Criteria

  1. Presence of metallic foreign bodies/objects 2. Selected medical devices and implants 3. Pacemakers, implantable defibrillators, life vests 4. Coronary artery stent within last 6 weeks (unless the stent is a MRI-inert chromium-cobalt stent) 5. Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within last 12 months 6. Atrial fibrillation that is not well rate controlled (heart rate >125) 7. Unstable angina within last 2 months that has not been fully evaluated by a cardiologist 8. Syncope within last 6 weeks 9. Hemodynamic instability (Systolic BP less than 100 or greater than 180) 10. Decompensated heart failure (inability to lie flat and perform a breath-hold). 11. Glomerular filtration rate (GFR) < 60 for those receiving gadolinium. 12. Labile GFR that is not stable/similar on last 2 measurements (for those receiving gadolinium). 13. Patients with GFR < 20 or on any form of dialysis. 14. Infiltrative cardiomyopathy (amyloid, sarcoid, hemachromatosis) 15. Recent surgery (within the last 3 months) 16. Prior stroke with large residual deficit 17. Presence of liver or respiratory failure 18. Pregnancy and nursing mothers 19. Claustrophobia 20. Known seizure disorder

Study Design

Phase
Early Phase 1
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Diagnostic
Masking
Single (Participant)

Arm Groups

ArmDescriptionAssigned Intervention
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.
  • Device: Diffusion Tensor MRI (DTI)
    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.
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.
  • Device: Diffusion Tensor MRI (DTI)
    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.
  • Drug: Gadolinium DOTA Meglumine
    Late Gadolinium enhancement
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.
  • Device: Diffusion Tensor MRI (DTI)
    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.

Recruiting Locations

Massachusetts General Hospital
Charlestown, Massachusetts 02129

More Details

Status
Unknown status
Sponsor
Massachusetts General Hospital

Study Contact

David E. Sosnovik, MD
617-724-3407
sosnovik@nmr.mgh.harvard.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.