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Active, Not Recruiting

NCT Number: NCT02270359

Research on Infarction With Open Arteries Using OCT and CMR

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").

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

21 year–99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

NYU Langone Medical Center

New York, 10016, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

OCT

Device

Optical coherence tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.

CMR

Procedure

Cardiac magnetic resonance imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (smelling)

contrast agent, Gadolinium

Drug

Gadolinium contrast will be administered during CMR

Primary outcomes

  1. The prevalence of plaque disruption

    Time frame: 1 Week

Secondary outcomes

  1. 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

    Time frame: 1 week

Other outcomes

  1. Event rate in follow-up: death, MI, heart failure, stroke

    Time frame: 1 Year

Sponsors and collaborators

Lead sponsor

NYU Langone Health

Other

Registry information

Official study title

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

Acronym: RIO

Important dates

Study start
2014
Primary completion
2025
Study completion
2025
First posted
Oct 21, 2014
Registry last updated
Sep 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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