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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

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:

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

Sites / Locations

Massachusetts General HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

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

NCT ID

NCT02973633

First Posted

November 19, 2016

Last Updated

March 1, 2022

Sponsor

Massachusetts General Hospital

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

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

Arm Title

Patients with Left Ventricular Hypertrophy

Arm Type

Active Comparator

Arm Description

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

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

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

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

result

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Diffusion MRI in Heart Failure

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