Ignite Creation Date:
2024-05-06 @ 8:26 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06374498
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-18
First Post:
2024-03-25
Brief Title:
Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
Sponsor:
Massachusetts General Hospital
Organization:
Massachusetts General Hospital
Study Overview
Official Title:
Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 subjects electronic medical records will be input into the studys 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None