Improved Heart MRI Techniques for Heart Disease

Recruiting at 1 trial location

Overseen By Ahmed M Gharib, M.D.

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Must not be taking: Metformin, Phosphodiesterase-5 inhibitors

Disqualifiers: Pregnancy, Pacemaker, Severe COPD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 2

4000 Participants Needed

Trial Summary

What is the purpose of this trial?

Background: - Imaging tests, such as magnetic resonance imaging (MRI), can provide information about heart and blood vessels. The tests let doctors can see the amount of blood vessel narrowing and vessel wall thickness. This information may help diagnose and treat heart disease and other conditions that lead to heart attacks. Better MRI methods are needed to improve heart disease diagnosis, especially by avoiding the use of radiation. Researchers are testing new techniques to improve the quality of heart MRI, compared with more complex studies like catheterization or angiography. Objectives: - To compare heart MRI techniques with other tests used to diagnose heart disease. Eligibility: - People at least 18 years of age who either have or may have heart disease, or are healthy volunteers. Design: * Participants will be screened with a physical exam, medical history, and blood tests. * They will have an angiography to study the inside of blood vessels. This test is an x-ray study of the blood vessels. It will be done either separately or as part of a set of tests to diagnose possible heart disease. * Participants will have at least one and up to five MRI scans. The scans will involve different methods of studying the heart and blood vessels. Participants may also have a computed tomography scan to confirm the findings of an MRI scan. * No treatment will be provided as part of this protocol.

Do I need to stop my current medications for the trial?

The trial information does not specify if you need to stop taking your current medications. However, if you are using metformin, you should not take it less than 24 hours before the CTA contrast administration.

What data supports the effectiveness of this treatment for heart disease?

Research shows that cardiovascular MRI (magnetic resonance imaging) is a reliable tool for evaluating heart structure and function, and it has been used successfully in various heart conditions, such as congenital heart disease and heart failure. The technology has advanced significantly, allowing for detailed and accurate heart imaging, which helps in diagnosing and managing heart diseases. ^{1 2 3 4 5}

Is cardiac MRI safe for humans?

Cardiac MRI is generally considered safe for humans as it is a non-invasive imaging technique that does not use ionizing radiation. It has been widely used in clinical practice for assessing heart conditions, and safety aspects have been reviewed in studies, particularly for stress cine magnetic resonance imaging. ^{1 3 6 7 8}

How does the treatment in the Improved Heart MRI Techniques for Heart Disease trial differ from other treatments for heart disease?

This treatment is unique because it uses advanced MRI techniques to non-invasively assess heart structure and function, offering detailed visualization and quantification of heart conditions. Unlike traditional methods, it provides comprehensive imaging that can identify various heart issues, such as coronary artery disease and cardiomyopathies, with high sensitivity and specificity. ^{1 4 9 10 11}

Research Team

Ahmed M Gharib, M.D.

Principal Investigator

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Eligibility Criteria

Adults over 18, with or at risk for heart disease (due to factors like smoking, obesity, diabetes), and healthy volunteers can join. They must be stable enough to visit the clinic and agree to participate. Those with MRI contraindications or severe medical conditions that prevent lying still are excluded.

Inclusion Criteria

I am stable enough to visit the clinic for the study.

I have been diagnosed with or suspected to have atherosclerosis.

I am healthy or have a condition affecting my chest, stomach area, or metabolism.

Exclusion Criteria

I've had an allergic reaction to gadolinium contrast despite taking allergy and cortisone meds.

My kidney function is reduced.

I need sedation to undergo MRI scans.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Imaging Assessment

Participants undergo a series of MRI scans to evaluate heart and blood vessel imaging techniques

4-8 weeks

1-5 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness of imaging techniques

4 weeks

Treatment Details

Interventions

• MR Imaging Techniques
• MR Imaging Techniques - 1
• MR Imaging Techniques - 2
• MR Imaging Techniques - 3
• MR Imaging Techniques - 4
• MR Imagining Techniques

Trial Overview The trial is testing new MRI techniques against other diagnostic tests for heart disease. Participants will undergo physical exams, blood tests, angiography, up to five different MRIs, and possibly a CT scan. No treatment is provided in this study.

Participant Groups

Group I: Group 4 Experimental Treatment 1 Intervention

Group 4 no known risk factors (control subjects)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries

Group II: Group 3 Experimental Treatment 1 Intervention

Group 3 will consist of subjects with a 10-year total CHD risk \>20% (high)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries

Group III: Group 2 Experimental Treatment 1 Intervention

Group 2 will consist of subjects with a 10-year total CHD risk 10-20% (intermediate)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries

Group IV: Group 1 Experimental Treatment 1 Intervention

Group 1 will consist of subjects with a 10-year total CHD risk \<10% (low)They will undergo a series of multiple small discovery studies in order to look at the multiple different MR methods of visualizing the coronary arteries

Who Is Running the Clinical Trial?

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Lead Sponsor

Trials

2,513

Recruited

4,366,000+

Findings from Research

Cardiovascular MRI is a rapidly evolving field with various techniques being developed to improve heart imaging, particularly for conditions like congenital heart disease.

Advanced MRI techniques are being applied to enhance the evaluation of heart conditions, indicating their growing importance in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI for physiology and function: technical advances in MRI of congenital heart disease. Haselgrove, JC., Simonetti, O.[2019]

Cardiac MR imaging has rapidly advanced in the last decade, allowing for reliable evaluation of heart structure and function with high spatial and temporal resolution, making it suitable for clinical use.

In a preliminary study of 58 cases at Sheba Medical Center, cardiac MR imaging was used for various indications, including congenital heart defects and suspected cardiac masses, highlighting its growing role in diagnosing complex cardiac conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Cardiac MRI: report on preliminary experience in Sheba Medical Center and review of main indications]. Konen, E., Frand, M., Friemark, D., et al.[2006]

Cardiovascular magnetic resonance imaging (CMR) techniques are validated for assessing important heart conditions, including myocardial function, blood flow (perfusion), and the extent of heart damage (infarction).

Ongoing development of these imaging techniques presents new research opportunities for exploring innovative treatment strategies and enhancing the capabilities of magnetic resonance imaging in cardiovascular health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the failing heart. Lauerma, K.[2017]

Recent technical advances in cardiovascular MRI, such as high-speed black blood and cine bright blood techniques, have significantly improved clinical imaging, making it a more effective tool for cardiac assessment.

These innovations, including multislice whole heart perfusion imaging and real-time imaging methods, position MRI as a leading choice for comprehensive cardiac imaging in various clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

MRI techniques for cardiovascular imaging. Pettigrew, RI., Oshinski, JN., Chatzimavroudis, G., et al.[2019]

Cardiovascular magnetic resonance (CMR) imaging is a powerful and flexible technique for assessing various cardiovascular diseases, highlighting its growing importance in clinical practice.

CMR provides detailed insights into heart structure and function, aiding in the diagnosis and management of cardiovascular conditions, although specific study details and outcomes were not provided in the abstract.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Multi-Faceted Utility of Cardiovascular Magnetic Resonance Imaging: Editorial on Special Issue "Advances in Cardiovascular Magnetic Resonance". Lu, M., Sirajuddin, A.[2023]

Cardiovascular magnetic resonance (CMR) is a safe, non-invasive imaging technique that provides detailed information about heart function and tissue characteristics without using ionizing radiation.

CMR has become increasingly important in clinical practice, particularly for assessing ischemic cardiomyopathy, highlighting its efficacy in diagnosing and managing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Role of cardiovascular magnetic resonance in acute and chronic ischemic heart disease. Baritussio, A., Scatteia, A., Bucciarelli-Ducci, C.[2018]

Cardiovascular magnetic resonance (CMR) is becoming essential in cardiology, providing precise assessments of heart function and structure, particularly for conditions like ischemic heart disease and heart failure.

The growing accessibility and expertise in CMR outside specialized centers enhance patient care by allowing for detailed evaluations, including unique assessments like myocardial iron overload.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation. Valbuena-López, S., Hinojar, R., Puntmann, VO.[2017]

Cardiac magnetic resonance (CMR) imaging has expanded significantly in its use for non-invasive detection of myocardial ischemia, highlighting its growing importance in clinical practice.

The review discusses the imaging technique, methodology, and safety aspects of stress cine magnetic resonance imaging, emphasizing its applicability in routine clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Current clinical applications of stress wall motion analysis with cardiac magnetic resonance imaging. Paetsch, I., Jahnke, C., Fleck, E., et al.[2015]

Four-dimensional flow cardiovascular magnetic resonance (4D-flow CMR) can visualize and quantify heart flow dynamics in under 10 minutes, making it a promising tool for clinical imaging protocols.

Diffusion tensor imaging (DTI) allows for rapid, non-invasive assessment of the heart's micro-architecture, which could enhance clinical understanding of various heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging: emerging techniques and applications. Chowdhary, A., Garg, P., Das, A., et al.[2022]

Cardiovascular magnetic resonance (CMR) is a highly effective non-invasive imaging technique that provides detailed assessments of heart structure and function, making it the gold standard for measuring ventricular volumes and systolic function.

CMR techniques, such as late gadolinium enhancement (LGE) imaging, are crucial for diagnosing heart conditions like infarction and various cardiomyopathies, and they also help identify inflammation and fibrosis, enhancing patient management and treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: applications and practical considerations for the general cardiologist. Arnold, JR., McCann, GP.[2021]

Cardiac magnetic resonance (CMR) imaging is a highly effective noninvasive technique that has significantly improved in resolution and speed over the last two decades, making it valuable for diagnosing and monitoring cardiovascular diseases.

CMR can assess various aspects of heart health, including morphology, function, perfusion, and tissue characterization, which supports its use in both diagnosis and follow-up after treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac MRI: technical basis. Russo, V., Lovato, L., Ligabue, G.[2020]

References

1. United States pubmed.ncbi.nlm.nih.gov

MRI for physiology and function: technical advances in MRI of congenital heart disease. [2019]

2. Israel pubmed.ncbi.nlm.nih.gov

[Cardiac MRI: report on preliminary experience in Sheba Medical Center and review of main indications]. [2006]

3. England pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of the failing heart. [2017]

4. United States pubmed.ncbi.nlm.nih.gov

MRI techniques for cardiovascular imaging. [2019]

5. Switzerland pubmed.ncbi.nlm.nih.gov

The Multi-Faceted Utility of Cardiovascular Magnetic Resonance Imaging: Editorial on Special Issue "Advances in Cardiovascular Magnetic Resonance". [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Role of cardiovascular magnetic resonance in acute and chronic ischemic heart disease. [2018]

7. Spain pubmed.ncbi.nlm.nih.gov

Cardiovascular Magnetic Resonance in Cardiology Practice: A Concise Guide to Image Acquisition and Clinical Interpretation. [2017]

8. England pubmed.ncbi.nlm.nih.gov

Current clinical applications of stress wall motion analysis with cardiac magnetic resonance imaging. [2015]

9. England pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance imaging: emerging techniques and applications. [2022]

10. England pubmed.ncbi.nlm.nih.gov

Cardiovascular magnetic resonance: applications and practical considerations for the general cardiologist. [2021]

11. Italy pubmed.ncbi.nlm.nih.gov

Cardiac MRI: technical basis. [2020]