Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Not Applicable

• Conditions: Cardiovascular Diseases; Coronary Artery Disease
• Interventions: Device: OCT-NIRAF

• Registration Number: NCT06374498
• Lead Sponsor: Massachusetts General Hospital

Brief Summary

Patients 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 patient, per artery, or per lesion basis.

Detailed Description

This study will provide preliminary data on the clinical value of intracoronary OCT-NIRAF imaging in patients 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. Patient 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 patients for whom coronary angiography provides a clinical indication for intravascular imaging or PCI without any exclusion criteria, 40 study subjects 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, patients 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), patients will undergo a follow-up study coronary CTA, to assess for plaque progression compared to the baseline coronary CTA.

Follow up: Patients 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.

Study Timeline

• Study First Submitted: 2024-03-25
• Study First Submitted QC: 2024-04-16
• Study First Posted: 2024-04-18
• Study Start: 2024-07-08
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-18
• Primary Completion: 2026-04-30
• Study Completion: 2027-04-30

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• Patients with stable CAD or acute coronary syndromes undergoing invasive coronary angiography in the MGH cardiac catheterization laboratory
• Patient is eligible for PCI
• Patients must be over the age of 18
• Patient must be able to give informed consent
• Women with childbearing potential must have a negative pregnancy test within seven days prior to the procedure

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Exclusion Criteria

• CLINICAL EXCLUSION CRITERIA:

  • Renal insufficiency (GRF<45 ml/min/1.73m2)
  • Pregnancy
  • Acute myocardial infarction: Patients with ST elevation MI will be excluded for at least 72 hours post event. Patients 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
  • Persons under the protection of justice, guardianship, or curatorship

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

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with stable CAD or acute coronary syndromes undergoing invasive coronary angiography	OCT-NIRAF	Patients referred to the Cardiology Division of the Massachusetts General Hospital, undergoing coronary angiography for stable or acute coronary disease and eligible for percutaneous coronary intervention (PCI) will be eligible for the study.

Primary Outcome Measures

Name	Time	Method
Plaque size estimation using OCT-NIRAF	Data will be analyzed within 1 year after the procedure.	Optically derived signatures (OCT-NIRAF) will be compared to plaque volume measured by CCTA at baseline.
Plaque progression estimate using OCT-NIRAF	Data will be analyzed within 1 year after the procedure.	Changes in plaque volume will be measured by CCTA at baseline and after 1 year. Optically derived signatures (OCT-NIRAF) obtained at baseline will be compared to changes in plaque volume.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States