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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve MRI techniques for diagnosing heart disease without radiation. Researchers compare different MRI methods (also known as Heart MRI or Cardiovascular Magnetic Resonance Imaging) to other common tests for heart issues, such as angiography, which uses X-rays to examine blood vessels. Suitable candidates for this trial include those with heart disease, those who suspect they might have it, and healthy volunteers. Participants will undergo various MRI scans and other imaging tests to assess the effectiveness of these methods. As an unphased trial, this study allows participants to contribute to advancements in non-invasive heart disease diagnosis.

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 prior data suggests that these MRI techniques are safe for heart disease diagnosis?

Research has shown that cardiac MRI is generally safe for most people. Studies have found it effectively diagnoses complex heart conditions without using radiation, enhancing its safety profile. In fact, cardiac MRI is considered the best method for assessing heart function.

For individuals with certain heart devices, such as pacemakers, safety depends on the device type. However, with careful procedures, MRI scans can still be performed safely. No major safety concerns have been reported for most people undergoing these tests. While safety always depends on individual health factors, cardiac MRI is well-tolerated and commonly used in medical settings. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these improved heart MRI techniques because they offer a non-invasive way to visualize coronary arteries with greater precision. Unlike standard imaging methods like CT scans or traditional MRIs, these advanced techniques aim to provide clearer and more detailed images of the heart without exposure to radiation. This has the potential to enhance the early detection and monitoring of heart disease, leading to better outcomes for patients by tailoring treatments more effectively to individual needs.

What evidence suggests that these MRI techniques are effective for diagnosing heart disease?

This trial will compare various MR Imaging Techniques for heart disease. Research has shown that cardiac MRI effectively diagnoses heart problems. Studies have found MRI to be the best method for assessing heart function and diagnosing coronary artery disease (CAD). For patients who might have CAD, MRI accurately aids in treatment decisions. Stress MRI, which evaluates blood flow and heart function under stress, has proven accurate for diagnosing and assessing risks in patients with stable chest pain. Large studies have demonstrated that using MRI to guide treatment improves outcomes in various heart diseases. Overall, MRI provides clear images of blood vessels and heart structures, reducing the need for more invasive tests. ^{1 4 6 7 8}

Who Is on the Research Team?

Ahmed M Gharib, M.D.

Principal Investigator

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

Are You a Good Fit for This Trial?

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

My kidney function is reduced.

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

I need sedation to undergo MRI scans.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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) 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]

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]

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 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]

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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3377522/

Cardiac Magnetic Resonance Imaging for the Diagnosis of ... The effectiveness of stress cardiac MRI for the detection of CAD in unstable patients with acute coronary syndrome was reported in only one study (N=35). Using ...

2. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.124.016523

Cardiovascular Magnetic Resonance: Past, Present, and ... In symptomatic patients with or suspected coronary artery disease CMR myocardial perfusion imaging is accurate and valuable to guide ...

3. nature.com nature.com/articles/s41591-024-02971-2

Screening and diagnosis of cardiovascular disease using ... Cardiac magnetic resonance imaging (CMR) is the gold standard for cardiac function assessment and plays a crucial role in diagnosing ...

4. jamanetwork.com jamanetwork.com/journals/jamacardiology/fullarticle/2805949

Diagnostic and Prognostic Value of Stress Cardiovascular ... Stress CMR is an accurate method to diagnose and risk stratify patients with stable chest pain and known or suspected coronary artery disease.

5. pubs.rsna.org pubs.rsna.org/doi/abs/10.1148/radiol.223008

Cardiac MRI: State of the Art | Radiology Large multicenter trials have shown the positive impact of MRI-based management on outcomes in several CVDs.

6. heart.org heart.org/en/health-topics/heart-attack/diagnosing-a-heart-attack/cardiac-mri

Cardiac Magnetic Resonance Imaging (MRI) A cardiac MRI is a test that gives detailed pictures of your heart and arteries. The test can help diagnose complex heart conditions. It is safe ...

7. ahajournals.org ahajournals.org/doi/10.1161/circulationaha.107.187256

Safety of Magnetic Resonance Imaging in Patients With ... There are several potential risks associated with MR scanning of specific cardiovascular devices that result from these processes.

8. acc.org acc.org/Latest-in-Cardiology/Articles/2024/05/21/10/30/Current-State-of-MRI-With-Cardiac-Devices

Current State of MRI With Cardiac Devices MRI examinations in patients with CIEDs are safe when rigorous protocols are followed regardless of the type of CIED.