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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06374498
• Other study ID #: 2023P003247
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 30, 2024
• Est. completion date: April 30, 2027

Study information

• Verified date: April 2024
• Source: Massachusetts General Hospital
• Contact: Nitasha Bhat, MD
• Phone: 617-724-4515
• Email: Tearneylabtrials[@]partners.org
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: April 30, 2027
• Est. primary completion date: April 30, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• CLINICAL EXCLUSION CRITERIA:

• Renal insufficiency (GRF<60 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

• Clinical instability that develops after IVUS imaging but prior to OCT-NIRAF imaging

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Coronary Artery Disease

Intervention

Device:
• OCT-NIRAF
Subjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram. In addition, the subject will also receive two Coronary Computed Tomography Angiography (CCTA) 12 months apart, and images will be analyzed.

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Plaque size estimation using OCT-NIRAF	Optically derived signatures (OCT-NIRAF) will be compared to plaque volume measured by CCTA at baseline.	Data will be analyzed within 1 year after the procedure.
Primary	Plaque progression estimate using OCT-NIRAF	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.	Data will be analyzed within 1 year after the procedure.