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Diffusion MRI in Heart Failure

Primary Purpose

Heart Failure, Myocardial Infarction, Left Ventricular Hypertrophy

Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Diffusion Tensor MRI (DTI)
Gadolinium DOTA Meglumine
Sponsored by
Massachusetts General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Heart Failure focused on measuring Heart Failure, Remodeling, Myocardial Infarction, Left Ventricular Hypertrophy, Diffusion Tensor MRI

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

Healthy Volunteers

Patients with Recent Myocardial Infarction

Patients with Left Ventricular Hypertrophy

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Myofiber Helix Angle
The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.

Secondary Outcome Measures

Correlation of Myofiber Helix Angle and Strain
The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.

Full Information

First Posted
November 19, 2016
Last Updated
March 1, 2022
Sponsor
Massachusetts General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02973633
Brief Title
Diffusion MRI in Heart Failure
Official Title
Diffusion MRI in Heart Failure
Study Type
Interventional

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2017 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Myocardial Infarction, Left Ventricular Hypertrophy
Keywords
Heart Failure, Remodeling, Myocardial Infarction, Left Ventricular Hypertrophy, Diffusion Tensor MRI

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Non-Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Healthy Volunteers
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients with Recent Myocardial Infarction
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Patients with Left Ventricular Hypertrophy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Diffusion Tensor MRI (DTI)
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Gadolinium DOTA Meglumine
Intervention Description
Late Gadolinium enhancement
Primary Outcome Measure Information:
Title
Myofiber Helix Angle
Description
The investigators aim to determine how the myofibers in the heart change their orientation in heart disease by measuring their helix angle.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Correlation of Myofiber Helix Angle and Strain
Description
The investigators aim to correlate how changes in fiber architecture correlate with changes in left ventricular strain.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David E. Sosnovik, MD
Phone
617-724-3407
Email
sosnovik@nmr.mgh.harvard.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David E. Sosnovik, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Charlestown
State/Province
Massachusetts
ZIP/Postal Code
02129
Country
United States
Individual Site Status
Recruiting

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
IPD will not be shared
Citations:
PubMed Identifier
27681278
Citation
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.
Results Reference
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Diffusion MRI in Heart Failure

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