Recruiting
Early Phase 1

Diffusion Tensor MRI

Sponsor:

Massachusetts General Hospital

Code:

NCT02973633

Conditions

Heart Failure

Myocardial Infarction

Left Ventricular Hypertrophy

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

Interventions

Diffusion Tensor MRI (DTI)

Gadolinium DOTA Meglumine

Study Details

Brief summary:

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

Heart Failure

Myocardial Infarction

Left Ventricular Hypertrophy

Study ID

NCT02973633

Start date

Jun 30, 2017

Status verified date

Dec, 2025

Completion date

Dec 31, 2028

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Accepted

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

Enrollment

160 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Diagnostic

Interventions and Outcome Measures

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.

Interventions

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.

Gadolinium DOTA Meglumine

Late Gadolinium enhancement

Primary outcome measure

  • Myofiber Helix Angle [ Time Frame: 12 months ]

Central Contacts and Locations

Central contacts

David E. Sosnovik, MD

617-724-3407sosnovik@nmr.mgh.harvard.edu

Locations

Massachusetts General Hospital

Recruiting

Charlestown, Massachusetts, United States, 02129

More Information

Sponsor

Massachusetts General Hospital

Last update posted

Dec 24, 2025

Last verified

Dec, 2025

Keywords

  • Heart Failure
  • Remodeling
  • Myocardial Infarction
  • Left Ventricular Hypertrophy
  • Diffusion Tensor MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Massachusetts General Hospital on 2025-12-24.