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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines heart attacks in individuals with unblocked arteries. It employs two advanced imaging techniques, Cardiac Magnetic Resonance Imaging (CMR) and Optical Coherence Tomography (OCT), to analyze heart plaques and detect any heart muscle issues. The aim is to gain insight into why heart attacks occur when arteries appear clear. Individuals may qualify if they have recently experienced heart attack symptoms, such as chest pain or other signs of heart distress, but have been informed that their arteries are open. As an unphased trial, this study provides a unique opportunity to contribute to groundbreaking research that could redefine the understanding of heart attacks.

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 prior data suggests that OCT and CMR imaging are safe for patients with myocardial infarction?

Research has shown that both Cardiac Magnetic Resonance Imaging (CMR) and Optical Coherence Tomography (OCT) are safe and generally easy for patients to undergo. Studies have found that patients can complete CMR without any problems, making it a dependable and safe choice for heart imaging. No safety issues have been reported with CMR compared to other methods.

Regarding OCT, research has confirmed its safety in heart procedures. Studies have carefully monitored its use and found it effective without adding extra risks. Safety boards have supervised trials to ensure patient safety, which has remained consistent.

Overall, both CMR and OCT have a strong safety record in clinical settings. This should reassure anyone considering joining a trial that uses these imaging methods. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Cardiac Magnetic Resonance Imaging (CMR) and Optical Coherence Tomography (OCT) for heart attacks without obstructive coronary artery disease (CAD) because these imaging techniques offer a closer look at the heart and blood vessels than traditional options. Unlike standard imaging methods, CMR provides detailed images of heart tissue, helping to identify damage and inflammation that might be missed otherwise. OCT allows for high-resolution images of the blood vessels, offering insights into plaque characteristics and vessel walls. Together, these technologies could lead to more accurate diagnoses and personalized treatment plans, potentially improving outcomes for patients with this condition.

What evidence suggests that OCT and CMR imaging are effective for assessing myocardial infarction with non-obstructive CAD?

This trial will use both Cardiac Magnetic Resonance Imaging (CMR) and Optical Coherence Tomography (OCT) to assess heart conditions. Research has shown that CMR effectively detects damage to the heart muscle and blood vessels after a heart attack, providing clear images that help predict future heart problems. It diagnoses heart issues 73.7% of the time when arteries are not blocked. Meanwhile, OCT has shown promise in assisting with heart procedures. Studies have found that OCT leads to better results than standard imaging methods, as it can lower the risk of heart attacks and other serious heart issues by providing detailed images of the arteries. Participants in this trial will undergo both OCT and CMR imaging to evaluate their heart condition. ^{2 3 6 7 8}

Who Is on the Research Team?

Harmony Reynolds, MD

Principal Investigator

NYU Langone Medical Center

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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 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 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]

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]

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5329738/

Cardiovascular magnetic resonance imaging assessment ... CMR imaging uniquely characterizes myocardial and microvascular injury in acute myocardial infarction (AMI), providing powerful surrogate markers of outcomes.

2. jacc.org jacc.org/doi/10.1016/j.jcmg.2022.12.029

Diagnostic and Prognostic Role of Cardiac Magnetic ... CMR-confirmed diagnosis of MINOCA was associated with an increased risk of major adverse cardiovascular events at follow-up. Acute myocardial ...

3. ahajournals.org ahajournals.org/doi/10.1161/CIRCIMAGING.122.015063

Cardiac Magnetic Resonance Imaging Versus Invasive ... The primary outcome (CMR-based versus invasive-based) occurred in 59% versus 52% (hazard ratio, 1.17 [95% CI, 0.86–1.57]), acute coronary ...

4. academic.oup.com academic.oup.com/ehjimp/article/2/1/qyae009/7604475

Cardiovascular magnetic resonance imaging-derived ... Cardiac magnetic resonance (CMR) imaging allows the assessment of both morphological and functional changes post-STEMI. ... LV function can be ...

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S014628062200024X

Diagnostic Value of Cardiac Magnetic Resonance Imaging ... The major findings of our systematic review and meta-analysis include: (1) The CMR has a high diagnostic yield of 73.7% when used among patients with working ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2016919/

Safety and diagnostic accuracy of stress cardiac magnetic ... CMR imaging was well tolerated (all patients completed the protocol) and no complications occurred. CMR was more sensitive (86% vs 48%, p = 0.0074) and more ...

7. sciencedirect.com sciencedirect.com/science/article/pii/S1097664725000626

Advanced cardiac magnetic resonance imaging for ... The ADVOCATE-CMR study aims to validate QP CMR, ∆T1 and OS-CMR imaging against invasive fractional flow reserve (FFR) for the detection of obstructive CAD.

8. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/23624930/

Cardiac magnetic resonance imaging safety following ... The purpose of this study is to demonstrate CMR safety shortly following stent PCI in AMI patients. We performed a retrospective analysis of ...