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Recruiting NCT02973633

Diffusion MRI in Heart Failure

Early Phase I Interventional Heart Failure Myocardial Infarction Left Ventricular Hypertrophy

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Diffusion Tensor MRI (DTI), Gadolinium DOTA Meglumine.
Who it may be relevant to
Registry conditions: Heart Failure, Myocardial Infarction, Left Ventricular Hypertrophy. Basic parameters: 18 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • 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

Primary outcome measures

  • Myofiber Helix Angle [Time frame: 12 months]
Secondary outcome measures (1)
  • Correlation of Myofiber Helix Angle and Strain [Time frame: 12 months]

Eligibility criteria

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Non-randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Diagnostic

Study locations

United States · 1 center
  • Massachusetts General Hospital — Charlestown

Publications

  • Mekkaoui C, Reese TG, Jackowski MP, Cauley SF, Setsompop K, Bhat H, Sosnovik DE. Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging. Radiology. 2017 Mar;282(3):850-856. doi: 10.1148/radiol.2016152613. Epub 2016 Sep 28. PMID 27681278

Identifiers

NCT: NCT02973633 · 2016P001898

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗