OCT + CMR Imaging for Heart Attack

(RIO Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: NYU Langone Health

Must not be taking: Vasospastic agents

Disqualifiers: Obstructive CAD, Pregnancy, eGFR<30, others

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

Compensation: Varies

Number of Visits: Unknown

15 Participants Needed

Trial Summary

What is the purpose of this trial?

The purpose of this study is to determine the prevalence of plaque disruption and to assess the composition of disrupted plaques in patients with myocardial infarction (MI) and non-obstructive coronary artery disease (CAD) using optical coherence tomography (OCT). Additionally, cardiac magnetic resonance imaging (CMR) will be used to detect myocardial abnormalities, which will be correlated to OCT findings to gain insight into the mechanisms of MI in patients with non-obstructive coronary artery disease (i.e. "open arteries").

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

The trial protocol does not specify whether you need to stop taking your current medications. However, recent use of certain vasospastic agents like cocaine, triptans, and ergot alkaloids is an exclusion criterion, so you may need to avoid these.

What data supports the effectiveness of the treatment Cardiac Magnetic Resonance Imaging (CMR) for heart attacks?

Cardiac Magnetic Resonance Imaging (CMR) is recognized as a reliable method for assessing heart function and structure without using harmful radiation. It is particularly useful in diagnosing and managing heart diseases, including heart attacks, by providing detailed images that help doctors understand the condition of the heart muscle and blood flow. ^{1 2 3 4 5}

Is OCT + CMR Imaging for Heart Attack safe for humans?

Research shows that cardiac magnetic resonance imaging (CMR) with gadolinium-based contrast agents is generally safe, with low rates of acute adverse events in a large number of patients. However, there are some risks, especially for those with certain heart conditions or devices, but these are typically low. ^{6 7 8 9 10}

How does the treatment using OCT + CMR Imaging for heart attacks differ from other treatments?

The OCT + CMR Imaging treatment is unique because it combines Optical Coherence Tomography (OCT) and Cardiac Magnetic Resonance Imaging (CMR) to provide detailed images of the heart without using ionizing radiation. This approach offers a comprehensive evaluation of heart function and tissue characteristics, which is not available with other imaging methods, potentially leading to better diagnosis and management of heart attacks. ^{1 3 4 11 12}

Research Team

Harmony Reynolds, MD

Principal Investigator

NYU Langone Medical Center

Eligibility Criteria

This trial is for adults over 21 with a recent heart attack and non-obstructive coronary artery disease, willing to consent to the study's procedures. It excludes those with other reasons for troponin elevation, significant coronary tortuosity, pregnancy, prior thrombolytic therapy for STEMI, stenosis in major vessels, known obstructive CAD history including PCI or CABG surgery, recent use of vasospastic agents, very low kidney function or MRI contraindications.

Inclusion Criteria

I have had a heart attack, confirmed by blood tests or an ECG.

I am 21 years old or older.

I have symptoms like chest pain that suggest a heart attack.

Exclusion Criteria

I have a major heart artery that is more than half blocked.

You are unable to have an MRI due to metal implants or foreign objects in your body.

My high troponin levels are due to another health issue, not a heart attack.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo coronary OCT just after the clinically indicated diagnostic angiogram and CMR within 1 week, typically within 72-96 hours

1 week

Follow-up

Participants are monitored for clinical events for at least 1 year

52 weeks

Treatment Details

Interventions

• Cardiac Magnetic Resonance Imaging (CMR)
• Gadolinium
• Optical Coherence Tomography (OCT)

Trial Overview The study aims to understand plaque disruption in heart attack patients using OCT (a light-based imaging) and CMR (advanced cardiac imaging with Gadolinium contrast). Researchers will compare images from both methods to learn about myocardial infarction causes when arteries are not blocked.

Participant Groups

Group I: MI without obstructive CAD Experimental Treatment 3 Interventions

MI without obstructive CAD, with OCT and CMR imaging

Who Is Running the Clinical Trial?

NYU Langone Health

Lead Sponsor

Trials

1,431

Recruited

838,000+

Findings from Research

Cardiac magnetic resonance (CMR) imaging is a valuable tool for assessing various heart conditions, particularly coronary artery disease and heart failure, which are significant health issues globally.

CMR offers unique tissue characterization capabilities that other imaging methods lack, providing critical diagnostic and prognostic insights into different heart diseases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Advances in Cardiovascular MRI for Diagnostics: Applications in Coronary Artery Disease and Cardiomyopathies. Salerno, M., Kramer, CM.[2021]

In a study of 728 patients and 25 volunteers, regadenoson stress cardiac magnetic resonance (CMR) was found to be safe, with no serious adverse events like death or myocardial infarction reported.

The most common side effects were mild, including dyspnoea (30%), chest discomfort (27%), and headache (15%), indicating that while some patients experienced discomfort, the overall tolerability of regadenoson CMR is high.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety and tolerability of regadenoson CMR. Nguyen, KL., Bandettini, WP., Shanbhag, S., et al.[2021]

In a study of 72,839 patients undergoing gadolinium-enhanced cardiac magnetic resonance imaging, the incidence of acute adverse events (AAEs) was low at 0.36%, with severe AAEs occurring in only 0.033% of cases.

AAE rates were influenced by factors such as the type of gadolinium-based contrast agent used, the presence of pharmacological stress during imaging, and the specific indications for the imaging, with higher rates observed during stress imaging.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. Uhlig, J., Lücke, C., Vliegenthart, R., et al.[2021]

In a study of 1334 cardiovascular magnetic resonance (CMR) procedures for patients with congenital heart disease, the overall incidence of adverse events (AEs) was low at 1.6%, with most being minor in severity.

The use of general anesthesia and the status of being an inpatient were identified as independent risk factors for experiencing AEs, particularly in the most critically ill patients, highlighting the need for careful monitoring in these cases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. Dorfman, AL., Odegard, KC., Powell, AJ., et al.[2013]

Cardiac MRI (CMR) is a powerful tool that not only evaluates heart function and structure but also assesses diastolic function, coronary plaque, and myocardial oxygen levels, enhancing its diagnostic capabilities.

Recent technological advancements, including improved imaging systems and techniques like T1 mapping, are expected to broaden the clinical applications of CMR, making it more effective in diagnosing and managing heart conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging: current status and future directions. Cannan, C., Friedrich, MG.[2013]

References

1. England pubmed.ncbi.nlm.nih.gov

The role of cardiovascular magnetic resonance in heart failure. [2019]

2. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Evaluation of myocardial ischemia in coronary artery disease with cardiac MR perfusion method: comparison with the results of catheter or CT angiography. [2016]

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

Advances in Cardiovascular MRI for Diagnostics: Applications in Coronary Artery Disease and Cardiomyopathies. [2021]

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

Comparison of wall thickening and ejection fraction by cardiovascular magnetic resonance and echocardiography in acute myocardial infarction. [2021]

5. Saudi Arabia pubmed.ncbi.nlm.nih.gov

Cardiac Imaging Integration in 2009 and Beyond: Cardiovascular magnetic resonance. [2021]

6. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of regadenoson CMR. [2021]

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

Optimized Prognosis Assessment in ST-Segment-Elevation Myocardial Infarction Using a Cardiac Magnetic Resonance Imaging Risk Score. [2019]

8. Germany pubmed.ncbi.nlm.nih.gov

Acute adverse events in cardiac MR imaging with gadolinium-based contrast agents: results from the European Society of Cardiovascular Radiology (ESCR) MRCT Registry in 72,839 patients. [2021]

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

Risk factors for adverse events during cardiovascular magnetic resonance in congenital heart disease. [2013]

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

Performing Cardiac Magnetic Resonance Imaging in Patients With Cardiac Implantable Electronic Devices: A Contemporary Review. [2019]

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

Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. [2021]

12. England pubmed.ncbi.nlm.nih.gov

Cardiac magnetic resonance imaging: current status and future directions. [2013]