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OCT + CMR Imaging for Heart Attack (RIO Trial)
N/A
Waitlist Available
Led By Harmony Reynolds, MD
Research Sponsored by NYU Langone Health
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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
Age ≥ 21 years
Must not have
Stenosis ≥50% of any major epicardial vessel on invasive angiography, as determined by the angiographer at the time of clinically ordered cardiac cath.
Thrombolytic therapy for STEMI (qualifying event)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is looking at whether or not a certain type of heart attack is related to a specific heart condition.
Who is the study for?
This trial is for adults over 21 with a recent heart attack and non-obstructive coronary artery disease, willing to consent to the study's procedures. It excludes those with other reasons for troponin elevation, significant coronary tortuosity, pregnancy, prior thrombolytic therapy for STEMI, stenosis in major vessels, known obstructive CAD history including PCI or CABG surgery, recent use of vasospastic agents, very low kidney function or MRI contraindications.
What is being tested?
The study aims to understand plaque disruption in heart attack patients using OCT (a light-based imaging) and CMR (advanced cardiac imaging with Gadolinium contrast). Researchers will compare images from both methods to learn about myocardial infarction causes when arteries are not blocked.
What are the potential side effects?
Potential side effects may include allergic reactions to the Gadolinium contrast used in CMR imaging. There might also be risks associated with OCT such as discomfort or complications related to catheter insertion.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have had a heart attack, confirmed by blood tests or an ECG.
Select...
I am 21 years old or older.
Select...
I have symptoms like chest pain that suggest a heart attack.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have a major heart artery that is more than half blocked.
Select...
I received clot-dissolving medication for a severe heart attack.
Select...
I have had heart blockages treated with surgery or stents.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: MI without obstructive CADExperimental Treatment3 Interventions
MI without obstructive CAD, with OCT and CMR imaging
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CMR
2014
Completed Phase 4
~240
OCT
2016
N/A
~1270
Find a Location
Who is running the clinical trial?
NYU Langone HealthLead Sponsor
1,415 Previous Clinical Trials
856,062 Total Patients Enrolled
Harmony Reynolds, MDPrincipal InvestigatorNYU Langone Medical Center
2 Previous Clinical Trials
30 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a major heart artery that is more than half blocked.You are unable to have an MRI due to metal implants or foreign objects in your body.My high troponin levels are due to another health issue, not a heart attack.Your blood vessels around the heart are too twisted, which could make a specific heart test riskier for you.I received clot-dissolving medication for a severe heart attack.I have had a heart attack, confirmed by blood tests or an ECG.My kidney function is poor, or I can't have certain dye tests for heart imaging.I am 21 years old or older.I have symptoms like chest pain that suggest a heart attack.Your coronary arteries show signs of dissection on an angiogram.I haven't used drugs like cocaine or migraine medications in the last month.I have had heart blockages treated with surgery or stents.
Research Study Groups:
This trial has the following groups:- Group 1: MI without obstructive CAD
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Heart Attack Patient Testimony for trial: Trial Name: NCT02270359 — N/A