Research on Infarction With Open Arteries Using OCT and CMR

NCT02270359 | Active Not Recruiting DMC FDA Device

• 1 other identifier: 1R01HL124204-01
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

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").

Conditions

Myocardial Infarction

Keywords

Myocardial Infarction; CAD

Outcome Measures

Primary Outcomes (1)

• The prevalence of plaque disruption

  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

  1 week

Other Outcomes (1)

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

  1 Year

Study Arms (1)

MI without obstructive CAD

OTHER

MI without obstructive CAD, with OCT and CMR imaging

Device: OCT; Procedure: CMR; Drug: contrast agent, Gadolinium

Interventions

OCT DEVICE

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

MI without obstructive CAD

CMR PROCEDURE

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

MI without obstructive CAD

contrast agent, Gadolinium DRUG

Gadolinium contrast will be administered during CMR

MI without obstructive CAD

Eligibility Criteria

• Age: 21 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• NYU Langone Health: lead

Study Sites (1)

NYU Langone Medical Center

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Myocardial Infarction

Interventions

Contrast Media; Gadolinium

Condition Hierarchy (Ancestors)

Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Vascular Diseases; Infarction; Ischemia; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Necrosis

Intervention Hierarchy (Ancestors)

Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals; Lanthanoid Series Elements; Metals, Rare Earth; Elements; Inorganic Chemicals; Metals

Study Officials

• Harmony Reynolds, MD

  NYU Langone Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 1, 2014
• First Posted: October 21, 2014
• Study Start: April 1, 2014
• Primary Completion: October 31, 2025
• Study Completion: October 31, 2025
• Last Updated: September 17, 2025

Record last verified: 2025-09

Locations

US (1)