Cardiovascular DiseasesNCT06374498
Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
A study testing OCT-NIRAF, LUMISIGHT Injection and OCT-NIRAF following LUMISIGHT Injection in people with Cardiovascular Diseases and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiovascular Diseases, Coronary Artery Disease
- What is being tested?
- OCT-NIRAF, LUMISIGHT Injection and OCT-NIRAF following LUMISIGHT Injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 8 Jul 2024to 30 Apr 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Massachusetts General Hospital
Boston, Massachusetts, 02114
About this study
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:
Read more
- NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.
- 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.
Read the detailed description
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.
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Being tested
- OCT-NIRAF, LUMISIGHT Injection, OCT-NIRAF following LUMISIGHT Injection
- Keywords
- Optical Coherence Tomography, NIRAF, Cardiovascular, CAD
- Medical subject headings
- Cardiovascular Diseases, Coronary Artery Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OCT-NIRAFDevice
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.
LUMISIGHT InjectionDrug
Up to 30 subjects will receive a single intravenous dose of LUMISIGHT administered 2-12 hours prior to their standard-of-care coronary procedure and experimental intravascular imaging.
OCT-NIRAF following LUMISIGHT InjectionDevice
Subjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram.
| Study group | Role | What they receive |
|---|---|---|
| Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography | Experimental | Participants 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. Receives: Device: OCT-NIRAF |
| LUMISIGHT Injection | Experimental | Patients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRF following injection of LUMISIGHT . The primary objective of Arm 2 is to assess the feasibility of intravascular detection and spatial localization of LUMISIGHT - derived near-infrared fluorescence during routine coronary imaging. Receives: Drug: LUMISIGHT Injection; Device: OCT-NIRAF following LUMISIGHT Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque size estimation using OCT-NIRAF
Optically derived signatures (OCT-NIRAF) will be compared to plaque volume measured by CCTA at baseline.
Measured: Data will be analyzed within 1 year after the procedure.
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.
Measured: Data will be analyzed within 1 year after the procedure.
Feasibility of using LUMISIGHT/Pegulicianine NIRF to detect the inflammation-driven fluorescence
The feasibility of using LUMISIGHT/Pegulicianine NIRF to detect the inflammation-driven fluorescence recorded via OCT-NIRAF catheters.
Measured: Data will be analyzed within 1 year after the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start8 Jul 2024
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiovascular DiseasesStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guillermo Tearney, Massachusetts General Hospital
- Investigators
- Guillermo J Tearney, MD, PhD, Principal investigator, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06374498
- Sponsor's protocol ID
- 2023P003247
- Status last verified
- Aug 2026
- First submitted
- 25 Mar 2024
- Last updated
- 14 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study to Determine the Clinical Significance of Intravascular OCT-NIRAF
- ClinicalTrials.gov ID
- NCT06374498
- Acronym / sponsor ID
- 2023P003247
- Conditions
- Cardiovascular Diseases, Coronary Artery Disease
- Keywords
- Optical Coherence Tomography, NIRAF, Cardiovascular, CAD
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- 8 Jul 2024 (actual)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2028 (estimated)
- First posted
- 18 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- NIRAF coronary artery signal level (patient, artery, lesion basis) is correlated with the severity of coronary artery disease.
- 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.
Detailed description
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography | Experimental | Device: OCT-NIRAFParticipants 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. |
| LUMISIGHT Injection | Experimental | Drug: LUMISIGHT Injection, Device: OCT-NIRAF following LUMISIGHT InjectionPatients undergoing coronary angiography for stable or acute coronary disease presentations and eligible for percutaneous coronary intervention (PCI) will be imaged with OCT-NIRF following injection of LUMISIGHT . The primary objective of Arm 2 is to assess the feasibility of intravascular detection and spatial localization of LUMISIGHT - derived near-infrared fluorescence during routine coronary imaging. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (27 listed)
- CLINICAL EXCLUSION CRITERIA:
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| OCT-NIRAFSubjects 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. | Device | Participants with stable CAD or acute coronary syndromes undergoing invasive coronary angiography |
| LUMISIGHT InjectionUp to 30 subjects will receive a single intravenous dose of LUMISIGHT administered 2-12 hours prior to their standard-of-care coronary procedure and experimental intravascular imaging. | Drug | LUMISIGHT Injection |
| OCT-NIRAF following LUMISIGHT InjectionSubjects will be imaged with OCT-NIRAF research catheter during their clinically indicated coronary angiogram. | Device | LUMISIGHT Injection |
Primary outcome
Plaque size estimation using OCT-NIRAF
Time frame: 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
Time frame: 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.
Feasibility of using LUMISIGHT/Pegulicianine NIRF to detect the inflammation-driven fluorescence
Time frame: Data will be analyzed within 1 year after the procedure.
The feasibility of using LUMISIGHT/Pegulicianine NIRF to detect the inflammation-driven fluorescence recorded via OCT-NIRAF catheters.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Guillermo J Tearney, MD, PhD principal investigator
Massachusetts General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OCT-NIRAF, LUMISIGHT Injection and OCT-NIRAF following LUMISIGHT Injection in people with Cardiovascular Diseases and Coronary Artery Disease, run by Massachusetts General Hospital at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 14 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque size estimation using OCT-NIRAF (time frame: Data will be analyzed within 1 year after the procedure.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Aug 2026.