Development of CIRC Technologies

Heart Failure Clinical Trial

— CIRC  

Official title:

Development of Cardiovascular Innovation Research Technologies

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05654272
• Other study ID #: 22-737
• Status: Recruiting
• Start date: September 9, 2022
• Est. completion date: September 9, 2042

Study information

• Verified date: February 2024
• Source: The Cleveland Clinic
• Contact: CIRC Program Coordinator
• Phone: 216 636-5373
• Email: circ[@]ccf.org
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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 our 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: September 9, 2042
• Est. primary completion date: September 9, 2032
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Aortic Diseases
• Atrial Fibrillation
• Cardiomyopathies
• Cardiovascular Diseases
• Congenital Heart Disease
• Coronary Artery Disease
• Heart Defects, Congenital
• Heart Diseases
• Heart Failure
• Heart Valve Diseases
• Ischemic Heart Disease
• Metabolic Cardiomyopathy
• Myocardial Ischemia
• Non-ischemic Cardiomyopathy
• Valvular Heart Disease
• Ventricular Fibrillation

Intervention

Diagnostic Test:
• MRI
Cardiac MRI

Locations

Country	Name	City	State
United States	Cardiovascular Innovation Research Center	Cleveland	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
The Cleveland Clinic

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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