Development of CIRC Technologies
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.
Conditions:
🦠 Cardiovascular Diseases 🦠 Heart Failure 🦠 Ischemic Heart Disease 🦠 Non-ischemic Cardiomyopathy 🦠 Valvular Heart Disease 🦠 Metabolic Cardiomyopathy 🦠 Congenital Heart Disease 🦠 Aortic Diseases 🦠 Atrial Fibrillation 🦠 Ventricular Fibrillation
🗓️ Study Start (Actual) 9 September 2022
🗓️ Primary Completion (Estimated) 9 September 2032
✅ Study Completion (Estimated) 9 September 2042
👥 Enrollment (Estimated) 1000
🔬 Study Type OBSERVATIONAL
📊 Phase N/A
Locations:
📍 Cleveland, Ohio, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * Age ≥ 18 years of age
    • * Provision of written informed consent
    • * If not healthy volunteer, must be diagnosed with cardiovascular disease

    Exclusion Criteria:

    • * 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)
Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: Yes

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 27 November 2022
  • First Submitted that Met QC Criteria 7 December 2022
  • First Posted 16 December 2022

Study Record Updates

  • Last Update Submitted that Met QC Criteria 5 February 2024
  • Last Update Posted 7 February 2024
  • Last Verified February 2024