Longitudinal Validation of CIRC Technologies

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorThe Cleveland Clinic

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 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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Age ≥ 18 years of age

Provision of written informed consent

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

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

1,000 Participants
are grouped into 2 trial groups
Group A: Healthy Volunteer
Group B: Cardiovascular Disease Patients

Trial outcomes

Primary outcomes

1

Myocardial Microstructure (Helix Angle) via Next Generation Cardiac MRI

The primary clinical objective of the clinical study is the qualitative comparison of cardiac microstructural phenotypes by cardiac MRI in patients and healthy controls

Time frame
Collected at each Research MRI timepoint

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Cleveland Clinic

Lead sponsor

National Institutes of Health (NIH)

Collaborator

National Heart, Lung, and Blood Institute (NHLBI)

Collaborator