Diffusion Tractography of the Entire Left Ventricle by Using Free-breathing Accelerated Simultaneous Multisection Imaging.
Choukri Mekkaoui, Timothy G Reese, Marcel P Jackowski...
https://pubmed.ncbi.nlm.nih.gov/27681278Actively Recruiting
Early Phase 1
Age: 18Years - 85Years
All Genders
Healthy Volunteers
ID02973633
Diffusion MRI in Heart Failure to Study Heart Muscle Changes in Patients with Myocardial Infarction and Left Ventricular Hypertrophy
Led by Massachusetts General Hospital · Updated on 2025-12-24
160
Participants Needed
1
Research Sites
52 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying heart failure development, focusing on the early structural changes in the heart that happen before symptoms appear. They aim to understand how the heart's microstructure changes during this progression by using diffusion tensor MRI (DTI) imaging. This study includes patients with recent heart attacks and those with left ventricular hypertrophy, both groups being at risk for heart failure, to observe these microstructural changes over time. The study involves three groups: healthy volunteers to establish normal heart muscle fiber patterns, patients with recent ST elevation myocardial infarctions, and patients with left ventricular hypertrophy and a history of heart failure. All participants will undergo serial DTI imaging of the heart, which tracks the diffusion of water to reveal muscle fiber orientation. Some patients will also receive gadolinium contrast to enhance imaging. These imaging sessions will be repeated over time to monitor changes in heart structure. Participants will be involved in multiple imaging visits where heart structure and function are assessed through MRI scans. The main outcome measure is the myofiber helix angle at 12 months, with secondary measures including its correlation with heart strain. Researchers will monitor participants' heart remodeling and function changes related to heart failure progression. The study will continue through 2028, with careful observation of heart microstructure changes and safety monitoring during and after imaging.
CONDITIONS
Brief Title
Diffusion MRI in Heart Failure
Who Can Participate
Age: 18Years - 85Years
All Genders
Healthy Volunteers
Eligibility Criteria
You may qualify if you...
- Healthy adults with no history of hypertension, diabetes, or heart disease
- Patients with ST elevation myocardial infarction within the last 6-10 weeks who are angina free and have seen a cardiologist since discharge
- Patients with an episode of heart failure within the last 12 months and left ventricular hypertrophy documented by echocardiogram or MRI
You will not qualify if you...
- Presence of metallic foreign bodies or objects
- Selected medical devices and implants such as pacemakers, implantable defibrillators, or life vests
- Coronary artery stent within the last 6 weeks unless it is an MRI-inert chromium-cobalt stent
- Known untreated ventricular arrhythmia such as sustained ventricular tachycardia within the last 12 months
- Atrial fibrillation not well rate controlled (heart rate over 125)
- Unstable angina within the last 2 months not fully evaluated by a cardiologist
- Syncope within the last 6 weeks
- Hemodynamic instability (systolic blood pressure less than 100 or greater than 180)
- Decompensated heart failure preventing lying flat and breath-holding
- Glomerular filtration rate less than 60 for those receiving gadolinium
- Labile or unstable glomerular filtration rate on last two measurements for those receiving gadolinium
- Patients with glomerular filtration rate less than 20 or on dialysis
- Infiltrative cardiomyopathies such as amyloid, sarcoid, or hemochromatosis
- Recent surgery within the last 3 months
- Prior stroke with large residual deficits
- Presence of liver or respiratory failure
- Pregnancy or nursing mothers
- Claustrophobia
- Known seizure disorder
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 12 months
Participants undergo Diffusion Tensor MRI (DTI) and may receive Gadolinium DOTA Meglumine to study heart muscle changes.
Serial imaging visits over 12 months
Trial Site Locations
Total: 1 location
1
Massachusetts General Hospital
Charlestown, Massachusetts, United States, 02129
Actively Recruiting
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Research Team
D
David E. Sosnovik, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
3
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