Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Coronary Artery Disease Clinical Trial

Official title: Study to Determine the Clinical Significance of Intravascular OCT-NIRAF

Status Not yet recruiting

Clinical Trial 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.

Clinical Trial 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 by phone: Patients will undergo standard-of-care cardiology follow-up and telephone clinical 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. ;

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease

• NCT number: NCT06374498
• Study type: Interventional
• Source: Massachusetts General Hospital
• Contact: Nitasha Bhat, MD
• Phone: 617-724-4515
• Email: Tearneylabtrials@partners.org
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Completion date: April 30, 2027