- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02270359
Research on Infarction With Open Arteries Using OCT and CMR (RIO)
November 6, 2023 updated by: NYU Langone Health
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
Intervention / Treatment
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
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
New York
-
New York, New York, United States, 10016
- NYU Langone Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
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
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Other: MI without obstructive CAD
MI without obstructive CAD, with OCT and CMR imaging
|
Optical coherence tomography (OCT): Intracoronary imaging for amount and type of plaque as well as plaque rupture, ulceration, dissection and/or thrombosis.
Cardiac magnetic resonance imaging (CMR): MRI of the heart to identify areas of infarction (damage) and/or edema (smelling)
Gadolinium contrast will be administered during CMR
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
The prevalence of plaque disruption
Time Frame: 1 Week
|
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
Time Frame: 1 week
|
1 week
|
Other Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Event rate in follow-up: death, MI, heart failure, stroke
Time Frame: 1 Year
|
1 Year
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Harmony Reynolds, MD, NYU Langone Medical Center
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 1, 2014
Primary Completion (Estimated)
June 30, 2025
Study Completion (Estimated)
June 30, 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)
November 8, 2023
Last Update Submitted That Met QC Criteria
November 6, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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