Research on Infarction With Open Arteries Using OCT and CMR (RIO)

Research on Infarction With Open Arteries Using OCT and CMR (RIO)

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").

Study Overview

• Status: Active, not recruiting
• Conditions: Myocardial Infarction
• Intervention / Treatment: Device: OCT; Procedure: CMR; Drug: contrast agent, Gadolinium

Detailed Description

In this single center, observational study, patients of both sexes with MI who are referred for cath will be enrolled. Those who have no obstructive CAD on clinically indicated coronary angiography, defined as no stenosis of >50% in any major epicardial vessel, will undergo coronary OCT just after the clinically indicated diagnostic angiogram, and CMR within 1 week, typically within 72-96 hours. Participants will be followed for clinical events for at least 1 year. 20 fully eligble participants will be recruited at NYU Langone Medical Center and Bellevue Hospital Center among a projected 200 enrolled patients.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years to 99 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Acute ischemic symptoms compatible with diagnosis of acute coronary syndrome (ACS) (chest pain or anginal equivalent symptoms at rest or new onset exertional anginal equivalent symptoms)
• Objective evidence of myocardial infarction (either or both of the following): Elevation of troponin to above the laboratory upper limit of normal (ULN) or ST segment elevation of ≥1mm on 2 contiguous ECG leads
• Willing to provide informed consent and comply with all aspects of the protocol
• Age ≥ 21 years

Exclusion Criteria:

• Stenosis ≥50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac cath.
• History of known obstructive CAD at angiography, including history of percutaneous coronary intervention (PCI) or coronary artery bypass grafting (CABG)
• Recent use of vasospastic agents, such as cocaine, triptans, ergot alkaloids (≤1 month)
• Alternate explanation for troponin elevation, such as hypertensive urgency, acute exacerbation of heart failure, chronic elevation due to kidney disease, pulmonary embolism, cardiac trauma
• Coronary dissection apparent on angiography
• Excessive coronary tortuosity which, in the opinion of the angiographer, increases the risks of OCT
• eGFR<30 or contraindication to additional contrast needed for OCT in the opinion of the angiographer or treating physician
• Contraindication to MRI (including but not limited to MRI-incompatible metal implants or foreign bodies)
• Pregnancy
• Thrombolytic therapy for STEMI (qualifying event)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: MI without obstructive CAD; MI without obstructive CAD, with OCT and CMR imaging	Device: OCT; Optical coherence tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.; Procedure: CMR; Cardiac magnetic resonance imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (smelling); Drug: contrast agent, Gadolinium; Gadolinium contrast will be administered during CMR

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The prevalence of plaque disruption	1 Week

Secondary Outcome Measures

Outcome Measure	Time Frame
Prevalence and pattern of LGE and myocardial edema Prevalence of different plaque types according to OCT Proportion of patients with identifiable MI etiology based on study testing	1 week

Other Outcome Measures

Outcome Measure	Time Frame
Event rate in follow-up: death, MI, heart failure, stroke	1 Year

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Investigators: Principal Investigator: Harmony Reynolds, MD, NYU Langone Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2014
• Primary Completion (Estimated): October 31, 2025
• Study Completion (Estimated): October 31, 2025

Study Registration Dates

• First Submitted: October 1, 2014
• First Submitted That Met QC Criteria: October 17, 2014
• First Posted (Estimated): October 21, 2014

Study Record Updates

• Last Update Posted (Estimated): September 17, 2025
• Last Update Submitted That Met QC Criteria: September 15, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: Myocardial Infarction; CAD
• Additional Relevant MeSH Terms: Vascular Diseases; Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Infarction; Necrosis; Myocardial Ischemia; Ischemia; Pathological Conditions, Signs and Symptoms; Myocardial Infarction; Pharmacologic Actions; Chemical Actions and Uses; Inorganic Chemicals; Elements; Metals; Specialty Uses of Chemicals; Lanthanoid Series Elements; Metals, Rare Earth; Diagnostic Uses of Chemicals; Contrast Media; Gadolinium
• Other Study ID Numbers: 1R01HL124204-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No