About this trial
Cardiovascular disease is the leading cause of death worldwide. Advanced cardiovascular imaging using Magnetic Resonance Imaging (MRI) has proven to be effective in providing gold standard myocardial tissue characterization. Moreover, the intrinsic advantage of MRI's lack of exposure to ionizing radiation is particularly beneficial. At the same time, blood work can be very useful in early detection of certain cardiomyopathy, such as amyloid. However, there is a lack of agreement of on which markers are the most sensitive. This multi-study will allow us the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases.
Our team has developed novel cardiac MRI techniques that leverages endogenous tissue properties to reveal a milieu of deep tissue phenotypes including myocardial inflammation, fibrosis, metabolism, and microstructural defects. Among these phenotypes, myocardial microstructure has proven to be most sensitive to early myocardial tissue damage and is predictive of myocardial regeneration. In this study, the investigators aim to further study the importance of cardiac microstructure revealed by MRI in patient and healthy population and compare this novel technology with conventional clinical biomarkers.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Age ≥ 18 years of age
Provision of written informed consent
If not healthy volunteer, must be diagnosed with cardiovascular disease
Disqualifiers
Vulnerable populations will be excluded from this study including Prisoners
Other contraindications to CMR imaging to be determined by standard MRI protocols
Decisionally impaired (e.g., dementia or cognitive disability)
Trial population
The study population will consist of approximately 1000 eligible subjects either with cardiovascular disease or are healthy subjects. The investigators plan to enroll 800 patients and 200 healthy controls.
Trial design
Cohort
Prospective
Treatments tested in this trial
MRI
Diagnostic testCardiac MRI
Treatment groups
Trial outcomes
Primary outcomes
Myocardial Microstructure (Helix Angle) via Next Generation Cardiac MRI
The primary clinical objective of the clinical study is to determine and compare cardiac microstructural phenotypes by cardiac MRI in patients and healthy controls
Myocardial Function (Ejection Fraction) via Conventional Cardiac MRI
Measure cardiac function with conventional cardiac MRI to compare with other primary outcome of microstructure
Sponsors and contacts
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