DE-MRI for Sleep Apnea-Related Heart Changes

Recruiting at 1 trial location

Overseen By Nassir Marrouche, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Tulane University

Disqualifiers: Chronic heart failure, Myocardial infarction, Valvular disease, others

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

Approved in 4 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 1

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to explore whether obstructive sleep apnea (OSA), a condition where breathing stops and starts during sleep, is linked to heart changes known as atrial fibrosis, without the presence of atrial fibrillation (a type of irregular heartbeat). Researchers use a special imaging technique called Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) to detect these heart changes. The trial includes several groups: those with mild, moderate, or severe OSA, with and without atrial fibrillation, and a control group without OSA or atrial fibrillation. Individuals diagnosed with OSA through a sleep study and without a history of irregular heartbeats might be a good fit for this study. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could improve understanding and treatment of OSA-related heart changes.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that DE-MRI is safe for detecting heart changes in sleep apnea patients?

Research has shown that Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) is safe because it does not use ionizing radiation, avoiding exposure to harmful rays found in some other imaging methods. Studies have found that DE-MRI provides a clear view of the airway during sleep, aiding in the assessment of conditions like sleep apnea without harming patients.

Patients have generally tolerated MRI well in sleep apnea studies. Previous research using MRI to study sleep-related breathing problems has not reported any major safety issues. This indicates that DE-MRI is a safe option for those considering participation in clinical trials using this technology. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) for assessing sleep apnea-related heart changes because it provides a unique insight into heart tissue that other methods can't. Unlike standard treatments for sleep apnea, which often involve using a CPAP machine to keep airways open, DE-MRI focuses on visualizing heart tissue to detect subtle changes and scarring. This method allows doctors to understand the impact of sleep apnea on heart health more accurately, potentially leading to better-targeted therapies in the future.

What evidence suggests that DE-MRI is effective for detecting heart changes related to sleep apnea?

Research has shown that a special type of MRI, called Delayed Enhancement MRI (DE-MRI), effectively detects heart changes in individuals with Obstructive Sleep Apnea (OSA). Studies indicate that DE-MRI can identify early signs of atrial fibrosis, or scarring in the heart, even before symptoms like an irregular heartbeat appear. This imaging method helps pinpoint individuals at higher risk for heart problems due to OSA. By detecting these changes early, DE-MRI can play a crucial role in preventing more serious heart issues. This trial will evaluate DE-MRI as a tool for individuals with varying levels of OSA, including mild, moderate, and severe cases, as well as those with and without atrial fibrillation. ^{6 7 8 9 10}

Who Is on the Research Team?

Amitabh Pandey, MD

Principal Investigator

Tulane University Medical Center

Are You a Good Fit for This Trial?

This study is for adults aged 18-75 with mild to severe Obstructive Sleep Apnea (OSA) diagnosed by sleep studies, who have normal kidney function. It excludes those with serious heart conditions, other advanced lung diseases, contraindications to MRI scans like allergies or certain implants, pregnant women, and individuals unable to consent or follow up.

Inclusion Criteria

I am between 18 and 75 years old and have been diagnosed with OSA through a sleep study.

I have no lung or heart disease and match the age and BMI criteria.

You had a test to check your kidney function in the last 6 months.

Exclusion Criteria

I cannot come back for follow-up visits.

I am unable to understand or sign the consent form.

No access to proper smartphone technology and/or internet

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline Assessment

Participants undergo DE-MRI to assess atrial fibrosis and collect baseline data

1 visit

1 visit (in-person)

Monitoring

Participants are monitored for arrhythmia occurrence using ECG check device

6 months

Follow-up

Participants are monitored for safety and effectiveness after baseline assessment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Delayed Enhancement Magnetic Resonance Imaging (DE-MRI)

Trial Overview

The trial aims to detect atrial fibrosis progression in OSA patients using Delayed Enhancement Magnetic Resonance Imaging (DE-MRI). It will also explore the relationship between OSA severity and fibrosis. Participants are divided into two groups: one with OSA and another healthy control group matched by age and BMI.

How Is the Trial Designed?

Group I: Group F Experimental Treatment 1 Intervention

Control - No OSA 10 control patients without OSA and without AF.

Group II: Group E Experimental Treatment 1 Intervention

Severe OSA and AF * At least 10 patients diagnosed with severe OSA (AHI\>30). * Diagnosis confirmed through polysomnography\* before enrollment. * Diagnosed with AF.

Group III: Group D Experimental Treatment 1 Intervention

Mild OSA and AF * At least 10 patients diagnosed with mild OSA (5\<AHI\<15). * Diagnosis confirmed through polysomnography\* before enrollment. * Diagnosed with AF.

Group IV: Group C Experimental Treatment 1 Intervention

Severe OSA * 10 patients diagnosed with severe OSA (AHI\>30) with no atrial fibrillation. * Diagnosis confirmed through polysomnography\* before enrollment.

Group V: Group B Experimental Treatment 1 Intervention

Moderate OSA * 10 patients diagnosed with moderate OSA (15\<AHI\<30) with no atrial fibrillation. * Diagnosis confirmed through polysomnography\* before enrollment.

Group VI: Group A Experimental Treatment 1 Intervention

Mild OSA * 10 patients diagnosed with mild OSA (5\<AHI\<15) with no atrial fibrillation. * Diagnosis confirmed through polysomnography\* before enrollment.

Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) is already approved in United States, European Union, Canada, Japan for the following indications:

Approved in United States as Magnetic Resonance Imaging with Delayed Enhancement for:

• Cardiovascular imaging
• Detection of myocardial infarction and fibrosis

Approved in European Union as DE-MRI for:

• Cardiovascular imaging
• Detection of myocardial infarction and fibrosis
• Assessment of cardiac structure and function

Approved in Canada as Delayed Enhancement MRI for:

• Cardiovascular imaging
• Detection of myocardial infarction and fibrosis

Approved in Japan as DE-MRI for:

• Cardiovascular imaging
• Detection of myocardial infarction and fibrosis

Who Is Running the Clinical Trial?

Tulane University

Lead Sponsor

Trials

129

Recruited

259,000+

Published Research Related to This Trial

Cardiovascular magnetic resonance (CMR) imaging has advanced significantly, providing high-resolution images of the heart and enabling detailed non-invasive tissue characterization through delayed contrast-enhanced CMR (DE-CMR).

DE-CMR can differentiate between ischaemic and non-ischaemic cardiomyopathies based on distinct patterns of hyperenhancement, highlighting its potential for diagnosing various cardiac diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ischaemic and non-ischaemic cardiomyopathies--cardiac MRI appearances with delayed enhancement. Jackson, E., Bellenger, N., Seddon, M., et al.[2007]

Delayed-enhancement magnetic resonance imaging (DE-MRI) is an effective tool for assessing myocardial viability and can provide similar diagnostic information as 99mTc-tetrofosmin myocardial scintigraphy in patients with coronary artery disease.

In a case study of a 71-year-old man, both DE-MRI and myocardial scintigraphy confirmed the diagnosis of previous lateral myocardial infarction, highlighting the reliability of DE-MRI in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Correlation between delayed-enhancement magnetic resonance and nitrate myocardial Tc-99m tetrofosmin scintigraphy in myocardial infarction: a case report. Feola, M., Rosso, GL., Biggi, A., et al.[2021]

In a study involving 18 patients undergoing atrial fibrillation ablation, the combination of delayed enhancement magnetic resonance imaging (DE-MRI) and magnetic resonance angiography (MRA) significantly improved the visualization of radiofrequency lesions compared to DE-MRI alone.

The fusion of DE-MRI with MRA provided better anatomical detail of the left atrium and pulmonary veins, leading to higher image quality scores, indicating that this method could enhance the effectiveness of AF ablation procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Visualization of the radiofrequency lesion after pulmonary vein isolation using delayed enhancement magnetic resonance imaging fused with magnetic resonance angiography. Kiuchi, K., Okajima, K., Shimane, A., et al.[2020]

In a study of 8 patients with nonobstructive hypertrophic cardiomyopathy, gadolinium-DTPA delayed-enhancement magnetic resonance imaging (de-MRI) effectively identified regions of myocardial fibrosis, which is linked to poorer prognosis.

The results showed that symptomatic patients had clear areas of fibrosis on de-MRI, while asymptomatic patients did not, suggesting that de-MRI could be a valuable tool for evaluating the severity of hypertrophic cardiomyopathy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Magnetic resonance imaging of myocardial fibrosis in hypertrophic cardiomyopathy. Wilson, JM., Villareal, RP., Hariharan, R., et al.[2019]

In a study of 36 scleroderma patients, delayed-enhancement magnetic resonance imaging (DE-MRI) successfully identified myocardial fibrosis in 83.3% of cases, highlighting its effectiveness as a noninvasive diagnostic tool.

Despite the high prevalence of myocardial fibrosis, the study found no significant impact on the burden or severity of ventricular arrhythmias or conduction disorders, except for a weak association between diffuse fibrosis and the number of premature ventricular contractions (PVCs) per day.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Relationship Between Ventricular Arrhythmias, Conduction Disorders, and Myocardial Fibrosis in Patients With Systemic Sclerosis. Muresan, L., Oancea, I., Mada, RO., et al.[2018]

In a study of 31 asymptomatic patients with biopsy-proven systemic sarcoidosis, delayed-enhancement MRI (DE-MRI) identified nonischemic myocardial fibrosis in 26% of participants, indicating its potential as a diagnostic tool.

The detected fibrosis was primarily located in the mid-myocardium, particularly in the basal inferoseptum and basal inferolateral wall, suggesting that DE-MRI can noninvasively reveal cardiac involvement in sarcoidosis even before symptoms appear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The utility of delayed-enhancement magnetic resonance imaging for identifying nonischemic myocardial fibrosis in asymptomatic patients with biopsy-proven systemic sarcoidosis. Cheong, BY., Muthupillai, R., Nemeth, M., et al.[2019]

In a study of 19 patients with their first acute anterior myocardial infarction (MI), delayed enhancement MRI (DE-MRI) revealed that myocardial damage was primarily located in the apical regions rather than the anteroseptal area, challenging the traditional classification of 'anteroseptal MI'.

All patients exhibited delayed hyperenhancement in the apex and apical anterior segments, with only 37% showing mid-ventricular anteroseptal hyperenhancement, indicating that the term 'anteroseptal MI' may not accurately reflect the actual damage observed in these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Anteroseptal or apical myocardial infarction: a controversy addressed using delayed enhancement cardiovascular magnetic resonance imaging. Selvanayagam, JB., Kardos, A., Nicolson, D., et al.[2019]

In a study involving 31 patients with chronic myocardial infarction (MI), delayed-enhanced magnetic resonance imaging (DE-MRI) using 0.15mmol/kg of contrast agent was found to be effective in detecting and assessing MI, showing no significant difference in results compared to the standard 0.2mmol/kg dose.

The study demonstrated a strong correlation in infarction size measurements between the two contrast doses, indicating that 0.15mmol/kg is sufficient for accurate MI assessment, which could potentially reduce contrast agent usage in clinical practice.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Delayed-enhancement magnetic resonance imaging at 3.0T using 0.15mmol/kg of contrast agent for the assessment of chronic myocardial infarction. Yang, J., Ma, H., Liu, J., et al.[2015]

Delayed enhancement magnetic resonance imaging (DE-MRI) is a reliable method for measuring infarct size in both acute and chronic myocardial infarction, showing excellent reproducibility with low variability among different observers.

In a study of 21 patients, DE-MRI demonstrated consistent infarct size measurements, suggesting it could effectively serve as a surrogate endpoint in clinical trials evaluating new reperfusion strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Reproducibility of chronic and acute infarct size measurement by delayed enhancement-magnetic resonance imaging. Thiele, H., Kappl, MJ., Conradi, S., et al.[2006]

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SDB is defined as an apnoea-hypopnoea index (AHI) ≥ 15/h (based on total recording time) and is categorised as predominantly OSA (≥ 50% of ...

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