Longitudinal Validation of CIRC Technologies

Sponsor
The Cleveland Clinic
Study ID
NCT07081711
Status
Not Yet Recruiting

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Conditions

  • Aortic Diseases
  • Atrial Fibrillation
  • Cardiovascular Diseases
  • Congenital Heart Disease
  • Heart Failure
  • Ischemic Heart Disease
  • Metabolic Cardiomyopathy
  • Non-ischemic Cardiomyopathy
  • Valvular Heart Disease
  • Ventricular Fibrillation

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Study Details

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 the unique opportunity to form a more comprehensive understanding for various cardiovascular diseases. The study 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.

Key Dates

First listed
Jul 23, 2025
Start date
Apr 30, 2026
Status verified
Mar 2026
Primary completion
Aug 31, 2035
Completion
Aug 31, 2037

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Healthy Volunteer
    Subjects without cardiovascular disease
  • Arm: Cardiovascular Disease Patients
    Patients with known or suspected cardiovascular disease

Primary Outcome Measure

Myocardial Microstructure (Helix Angle) via Next Generation Cardiac MRI [ Time Frame: Collected at each Research MRI timepoint ]

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