Longitudinal Validation 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 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.

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Key information

Conditions

Cardiovascular Diseases Aortic Diseases Arrhythmias, Cardiac Atrial Fibrillation Cardiovascular Abnormalities Congenital Abnormalities Congenital Heart Disease Congenital, Hereditary, and Neonatal Diseases and Abnormalities Heart Defects, Congenital Heart Diseases Heart Failure Heart Valve Diseases Ischemic Heart Disease Metabolic Cardiomyopathy Myocardial Ischemia Non-ischemic Cardiomyopathy Pathologic Processes Pathological Conditions, Signs and Symptoms Valvular Heart Disease Vascular Diseases Ventricular Fibrillation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

The primary clinical objective of the clinical study is to determine and compare cardiac microstructural phenotypes by cardiac MRI in patients and healthy controls and their relationship to cardiac structure/function with these MRI technologies.

Aim 1: What are the myocardial microstructure phenotypes in both patients with cardiovascular disease and healthy cohorts? Are they linked to other prevalent macro structure and functional abnormalities?

The hypothesis is that the investigators can develop the next generation cardiac MRI exam that is faster, more robust, and more efficient for clinic use.

The enrolled subjects will do ONE of the following:

Receive an extended clinical cardiac MRI exam. An MRI is an imaging technique used in radiology to make an accurate picture of the body. In this study the investigators will be focusing on the heart. The participant's routine clinical cardiac MRI exam will be extended by up to 25 min to perform a truncated research cardiac MRI protocol. The extended clinical cardiac MRI will take approximately one hour in total. The investigators may review the medical records to follow-up their medical status up to 5 years after start of the study.

OR:

Receive a research cardiac non-contrast MRI exam. An MRI is an imaging technique used in radiology to make an accurate picture of the body. In this study the investigators will be focusing on the heart. The research cardiac MRI will take approximately one to two hours in total. The investigators may review the medical records to follow-up their medical status up to 5 years after start of the study

Optionally, if the subjects agree, the blood samples will be collected:

Give blood sample for research purpose only. The blood draw is used to correlate the clinical blood biomarkers to the cardiac MRI data to help us better understand and validate the clinical utility of the novel cardiac MRI techniques. The blood draws should approximately take 20 minutes. The blood draw will take place in the doctor's office or at Mellen center private preparation by a registered nurse or approved technician. The blood will be stored with a unique code at Cleveland Clinic BioRepository for up to 10 years, and disposed following Cleveland Clinic guidelines. It may be used for future research in the Cleveland Clinic. Only members of the research team will have access to the participant's samples.

For healthy control:

Only one cardiac MRI is needed, and it will be non-contrast MRI.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age ≥ 18 years of age
Provision of written informed consent

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)

Treatment and study plan

Primary outcomes

Myocardial Microstructure (Helix Angle) via Next Generation Cardiac MRI

Time frame: Collected at each Research MRI timepoint

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

Sponsors and collaborators

Lead sponsor

The Cleveland Clinic

Other

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
National Institutes of Health (NIH)

Registry information

Important dates

Study start: 2026
Primary completion: 2035
Study completion: 2037
First posted: Jul 23, 2025
Registry last updated: Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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