DE-MRI for Sleep Apnea-Related Heart Changes

Recruiting in Palo Alto (17 mi)

+1 other location

Overseen by Amitabh Pandey, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Tulane University

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

No Placebo Group

Approved in 4 Jurisdictions

Trial Summary

What is the purpose of this trial?

The investigators hypothesize that Obstructive Sleep Apnea (OSA) is an independent risk factor for atrial fibrosis development. The investigators aim to prove the presence of atrial fibrosis on Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) in OSA patients without atrial fibrillation (AF).

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 data supports the effectiveness of the treatment Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) for Sleep Apnea-Related Heart Changes?

DE-MRI is effective in identifying heart muscle damage and fibrosis (scarring) in various heart conditions, which suggests it could help detect heart changes related to sleep apnea. ^{1 2 3 4 5}

Is DE-MRI generally safe for humans?

Delayed-enhancement magnetic resonance imaging (DE-MRI) has been used safely in various studies to assess heart conditions like myocardial infarction and fibrosis. It involves the use of a contrast agent, which is generally well-tolerated, but as with any medical procedure, there may be risks, so it's important to discuss with your doctor. ^{2 4 6 7 8}

How is the treatment DE-MRI unique for sleep apnea-related heart changes?

DE-MRI is unique because it is a noninvasive imaging technique that can identify heart tissue changes, such as fibrosis (scarring), which may not be detected by other methods. Unlike traditional treatments that focus on managing symptoms, DE-MRI provides detailed images to help understand the underlying heart changes associated with sleep apnea. ^{1 2 3 4 9}

Research Team

Amitabh Pandey, MD

Principal Investigator

Tulane University Medical Center

Eligibility Criteria

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

Trial Timeline

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

Treatment Details

Interventions

• Delayed Enhancement Magnetic Resonance Imaging (DE-MRI) (Procedure)

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.

Participant Groups

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 Canada, Japan for the following indications:

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+

James Zanewicz

Tulane University

Chief Medical Officer

MD from Tulane University

Elaine Hamm

Tulane University

Chief Executive Officer since 2022

PhD in Microbiology from the University of Oklahoma

Findings from Research

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 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]

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 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]

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]

References

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

Relationship Between Ventricular Arrhythmias, Conduction Disorders, and Myocardial Fibrosis in Patients With Systemic Sclerosis. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Anteroseptal or apical myocardial infarction: a controversy addressed using delayed enhancement cardiovascular magnetic resonance imaging. [2019]

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

Ischaemic and non-ischaemic cardiomyopathies--cardiac MRI appearances with delayed enhancement. [2007]

4. England pubmed.ncbi.nlm.nih.gov

Correlation between delayed-enhancement magnetic resonance and nitrate myocardial Tc-99m tetrofosmin scintigraphy in myocardial infarction: a case report. [2021]

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

Reproducibility of chronic and acute infarct size measurement by delayed enhancement-magnetic resonance imaging. [2006]

6. Japan 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. [2020]

7. Ireland 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. [2015]

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

Magnetic resonance imaging of myocardial fibrosis in hypertrophic cardiomyopathy. [2019]

9. Italy 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. [2019]