Development of CIRC Technologies

NCT05654272 | Recruiting

• 1 other identifier: 22-737
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 1

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; Metabolic Cardiomyopathy; Congenital Heart Disease; Aortic Diseases; Atrial Fibrillation; Ventricular Fibrillation

Keywords

MRI

Outcome Measures

Primary Outcomes (2)

• Myocardial Microstructure (Helix Angle) via Next Generation Cardiac MRI

  The primary clinical objective of the clinical study is to determine and compare cardiac microstructural phenotypes by cardiac MRI in patients and healthy controls

  20 years

• Myocardial Function (Ejection Fraction) via Conventional Cardiac MRI

  Measure cardiac function with conventional cardiac MRI to compare with other primary outcome of microstructure

  20 years

Study Arms (2)

Normal

Normal volunteers \>=18 years older

Diagnostic Test: MRI

Cardiovascular Disease Patient

\>=18years older with known prior cardiovascular disease

Diagnostic Test: MRI

Interventions

MRI DIAGNOSTIC_TEST

Cardiac MRI

Cardiovascular Disease Patient; Normal

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: 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
• If not healthy volunteer, must be diagnosed with cardiovascular disease

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

• The Cleveland Clinic: lead

Study Sites (1)

Cardiovascular Innovation Research Center

Cleveland, Ohio, 44195, United States

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

Blood draw

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

Central Study Contacts

CIRC Program Coordinator

CONTACT

216 636-5373; circ@ccf.org

CIRC Study Coordinator

CONTACT

chens7@ccf.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 20 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Cardiovascular Innovation Research Center

Study Record Dates

• First Submitted: November 27, 2022
• First Posted: December 16, 2022
• Study Start: September 9, 2022
• Primary Completion (Estimated): September 9, 2032
• Study Completion (Estimated): September 9, 2042
• Last Updated: April 9, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)