Longitudinal Validation of CIRC Technologies

NCT07081711 | Not Yet Recruiting

• 2 other identifiers: 25-166R01HL151704
• Study Type: observational
• Target: 1,000
• Locations: 0 countries
• Sites: N/A

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 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.

Conditions

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

Keywords

MRI

Outcome Measures

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

  Collected at each Research MRI timepoint

Study Arms (2)

Healthy Volunteer

Subjects without cardiovascular disease

Cardiovascular Disease Patients

Patients with known or suspected cardiovascular disease

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• Age ≥ 18 years of age
• Provision of written informed consent

You may not qualify if:

• 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)

Sponsors & Collaborators

• National Institutes of Health (NIH): collaborator
• The Cleveland Clinic: lead
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Biospecimen

Retention: SAMPLES WITH DNA

Blood collection

MeSH Terms

Conditions

Cardiovascular Diseases; Heart Failure; Myocardial Ischemia; Heart Valve Diseases; Heart Defects, Congenital; Aortic Diseases; Atrial Fibrillation; Ventricular Fibrillation

Condition Hierarchy (Ancestors)

Heart Diseases; Vascular Diseases; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Arrhythmias, Cardiac; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Innovation Research Center

Study Record Dates

• First Submitted: April 9, 2025
• First Posted: July 23, 2025
• Study Start: April 1, 2026
• Primary Completion (Estimated): August 1, 2035
• Study Completion (Estimated): August 1, 2037
• Last Updated: March 23, 2026

Record last verified: 2026-03