Recruiting

Observational Study

Sponsor:

The Cleveland Clinic

Code:

NCT05654272

Conditions

Cardiovascular Diseases

Heart Failure

Ischemic Heart Disease

Non-ischemic Cardiomyopathy

Valvular Heart Disease

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

MRI

Study Details

Brief summary:

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

Study ID

NCT05654272

Start date

Sep 9, 2022

Status verified date

Apr, 2026

Completion date

Sep 9, 2042

Anticipated

Primary completion date

Sep 9, 2032

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

1000 participants

Anticipated

Interventions and Outcome Measures

Arms

Normal

Normal volunteers >=18 years older

Cardiovascular Disease Patient

>=18years older with known prior cardiovascular disease

Interventions

MRI

Cardiac MRI

Primary outcome measure

  • Myocardial Microstructure (Helix Angle) via Next Generation Cardiac MRI [ Time Frame: 20 years ]
  • Myocardial Function (Ejection Fraction) via Conventional Cardiac MRI [ Time Frame: 20 years ]

Central Contacts and Locations

Central contacts

CIRC Program Coordinator

216 636-5373circ@ccf.org

CIRC Study Coordinator

chens7@ccf.org

Locations

Cardiovascular Innovation Research Center

Recruiting

Cleveland, Ohio, United States, 44195

Contacts

Principal Investigator:

Christopher Nguyen, PhD

More Information

Sponsor

The Cleveland Clinic

Last update posted

May 8, 2026

Last verified

Apr, 2026

Keywords

  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The Cleveland Clinic on 2026-05-08.