Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

There are 2 arms to this study.

Arm 1: 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.

Arm 2: Participants undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRAF following injection of LUMISIGHT. The primary objective is to assess the feasibility of intravascular detection and spatial localization of LUMISIGHT during routine coronary imaging.

Arm 1:

This study will provide preliminary data on the clinical value of intracoronary OCT-NIRAF imaging in participants undergoing invasive coronary angiography in the cardiac catheterization laboratory. This is a single site, prospective feasibility study where 40 study subjects undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will undergo intravascular imaging, including standard-of-care IVUS and then OCT-NIRAF pullback imaging conducted during an iodinated contrast flush. Patients will be consented prior to catheterization. Participant characteristics such as age, sex, BMI, and current medication regimen will be recorded. Standard of care blood chemistry will be reviewed and lab values from the subject's electronic medical records will be input into the study's Case Report Form when available. A complete medical history and data regarding prescribed cardiac medications also be transcribed from the EMR into the CRF.

Coronary Angiography will be performed. For participants for whom coronary angiography provides a clinical indication for intravascular imaging or PCI without any exclusion criteria, 40 study participants will undergo intravascular imaging, including standard-of-care IVUS and then research study OCT-NIRAF pullback imaging, conducted during an iodinated contrast flush.

Intravascular imaging of the PCI target artery will be done prior to PCI unless the interventional cardiologist determines that intervention is required to deliver the imaging catheters. The other major coronary arteries may also be imaged by IVUS and OCT-NIRAF based on clinical assessment of the appropriateness of imaging by the interventional cardiologist.

In addition, participants will obtain a baseline coronary CTA at MGH, using standard clinical protocols in the MGH Department of Radiology.

Follow up imaging: After 12 months (+/- 28 days), participants will undergo a follow-up study coronary CTA, to assess for plaque progression compared to the baseline coronary CTA.

Follow up: Participants will undergo standard-of-care cardiology follow-up and medical record review follow-up by study staff at 1 month (+/- 7 days), 6 months (+/- 28 days), and 1 year (+/- 28 days). After completion of the CCTA and final telephone 12-month follow-up, patients will be released from the study.

Arm 2:

This study will provide preliminary data on the clinical value of intracoronary OCT-NIRAF imaging following LUMISIGHT injection in participants undergoing invasive coronary angiography in the cardiac catheterization laboratory. This is a single site, prospective feasibility study where 30 study subjects undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will undergo intravascular imaging, including standard-of-care IVUS and then OCT-NIRAF pullback imaging conducted during an iodinated contrast flush. Patients will be consented prior to catheterization. Participant characteristics such as age, sex, BMI, and current medication regimen will be recorded. Standard of care blood chemistry will be reviewed and lab values from the subject's electronic medical records will be input into the study's Case Report Form when available. A complete medical history and data regarding prescribed cardiac medications also be transcribed from the EMR into the CRF.

LUMISIGHT injection will occur 2-12 hours prior to intravascular imaging procedure. Coronary Angiography will be performed. For participants for whom coronary angiography provides a clinical indication for intravascular imaging or PCI without any exclusion criteria, 30 study participants will undergo intravascular imaging, including standard-of-care IVUS and then research study OCT-NIRAF pullback imaging, conducted during an iodinated contrast flush.

Intravascular imaging of the PCI target artery will be done prior to PCI unless the interventional cardiologist determines that intervention is required to deliver the imaging catheters. The other major coronary arteries may also be imaged by IVUS and OCT-NIRAF based on clinical assessment of the appropriateness of imaging by the interventional cardiologist.

Arm 1:

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-approved cardiac drug or device
  • Participants under the protection of justice, guardianship, or curatorship

CARDIAC CATHETERIZATION LABORATORY - EXCLUSION CRITERIA (AFTER DIAGNOSTIC CORONARY ANGIOGRAM):

• Participant deemed not indicated for intravascular imaging or PCI
• Inability to perform intravascular imaging of a target artery
• Left main disease >= 50% stenosis in participants that do not have a functioning LAD bypass graft
• Clinical instability that develops after IVUS imaging but prior to OCT-NIRAF imaging

Arm 2: Because of the additional injection of LUMISIGHT, the following exclusion criteria (in addition to the criteria above) will be added:

ADDITIONAL EXCLUSION CRITERIA:

• Renal insufficiency (GRF <60 ml/min /1.73m2 )
• History of hypersensitivity to pegulicianine
• History of allergic reaction to oral or intravenous contrast agents
• History of allergic reaction to polyethylene glycol (PEG)
• History of any documented allergic or anaphylactic reactions i.e to drugs or food (eggs, shellfish etc.) or chemicals (rubber, latex etc.) or other clinically significant allergies
• Patients who have taken an investigational drug within 14 days of enrollment
• Patients with uncontrolled hypertension defined as persistent systolic blood pressure > 180 mm Hg, or diastolic blood pressure > 110 mm Hg; those subjects with known HTN should be under these values while under pharmaceutical therapy
• Severe concurrent illnesses including, but not limited to ongoing or major or severe active infections, symptomatic congestive heart failure, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements.