Study to Determine the Clinical Significance of Intravascular OCT-NIRAF (NCT06374498) | Clinical Trial Compass
By InvitationNot Applicable
Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
United States40 participantsStarted 2024-07-08
Plain-language summary
Participants undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF at baseline and with CCTA 12 months apart to demonstrate that:
1. NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.
2. NIRAF coronary artery signal level is a predictor of plaque progression on a per participant, per artery, or per lesion basis.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography in the MGH cardiac catheterization laboratory
* Participant is eligible for PCI
* Participants must be over the age of 18
* Participant must be able to give informed consent
* Women with childbearing potential must have a negative pregnancy test within seven days prior to the procedure
Exclusion Criteria:
* CLINICAL EXCLUSION CRITERIA:
* Renal insufficiency (GRF\<45 ml/min/1.73m2)
* Pregnancy
* Acute myocardial infarction: Participants with ST elevation MI will be excluded for at least 72 hours post event. Participants with non-ST elevation MI will be excluded if they have evidence of ongoing ischemia defined as chest pain or new ECG changes in the previous 12 hours and/or rising cardiac biomarker enzymes (e.g., troponin or CKMB)
* Evidence of ongoing or active clinical instability, including acute chest pain (sudden onset), cardiogenic shock, unstable blood pressure with systolic blood pressure \<90 mmHg, and severe congestive heart failure (NYHA III or IV) or acute pulmonary edema,
* Emergent procedures
* Ejection fraction \<= 35%
* Clinically significant bleeding within the past 14 days
* Any active, serious, life-threatening disease with a life expectancy of less than 12 months
* Inability to be evaluated at follow-up
* Currently enrolled in another study utilizing OCT imaging, or in an investigational trial that involves a non-ap…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Plaque size estimation using OCT-NIRAF
Timeframe: Data will be analyzed within 1 year after the procedure.
2
Plaque progression estimate using OCT-NIRAF
Timeframe: Data will be analyzed within 1 year after the procedure.