Back to resultsResearch on Infarction With Open Arteries Using OCT and CMR (RIO)
Primary Purpose
Myocardial Infarction
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
OCT
CMR
contrast agent, Gadolinium
Sponsored by
About this trial
This is an interventional diagnostic trial for Myocardial Infarction focused on measuring Myocardial Infarction, CAD
Eligibility Criteria
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)
Sites / Locations
- NYU Langone Medical Center
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
MI without obstructive CAD
Arm Description
MI without obstructive CAD, with OCT and CMR imaging
Outcomes
Primary Outcome Measures
The prevalence of plaque disruption
Secondary Outcome Measures
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02270359
Brief Title
Research on Infarction With Open Arteries Using OCT and CMR
Acronym
RIO
Official Title
Research on Infarction With Open Arteries Using OCT and CMR (RIO)
Study Type
Interventional
2. Study Status
Record Verification Date
December 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
April 2014 (Actual)
Primary Completion Date
June 30, 2025 (Anticipated)
Study Completion Date
June 30, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
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
Data Monitoring Committee
Yes
5. Study Description
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").
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Myocardial Infarction
Keywords
Myocardial Infarction, CAD
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
MI without obstructive CAD
Arm Type
Other
Arm Description
MI without obstructive CAD, with OCT and CMR imaging
Intervention Type
Device
Intervention Name(s)
OCT
Intervention Description
Optical coherence tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
Intervention Type
Procedure
Intervention Name(s)
CMR
Intervention Description
Cardiac magnetic resonance imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (smelling)
Intervention Type
Drug
Intervention Name(s)
contrast agent, Gadolinium
Intervention Description
Gadolinium contrast will be administered during CMR
Primary Outcome Measure Information:
Title
The prevalence of plaque disruption
Time Frame
1 Week
Secondary Outcome Measure Information:
Title
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 Pre-specified Outcome Measures:
Title
Event rate in follow-up: death, MI, heart failure, stroke
Time Frame
1 Year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Harmony Reynolds, MD
Organizational Affiliation
NYU Langone Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
NYU Langone Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Research on Infarction With Open Arteries Using OCT and CMR
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