Carotid Artery Diseases, Peripheral Arterial Disease
Conditions
Brief summary
Active inflammation plays a key role in causing Coronary Artery Disease (CAD) and Peripheral Arterial Disease (PAD). Since inflammation is so important in how these diseases start, are diagnosed, and treated, being able to see it clearly in each patient could lead to more personalized and effective care - and may help prevent heart attacks. Right now, there's no imaging technology available to clearly see inflammation inside the coronary arteries. The investigators hope to learn how an imaging drug; called LUMISIGHT (Pegulicianine) can help detect inflammation in blood vessels compared with saline. If the investigators find out that LUMISIGHT is active in humans, the investigators might be able to use it for detecting plaque risk in the future.
Detailed description
Objective of this research is to find out if a new imaging drug called LUMISIGHT can show inflammation inside blood vessels for participants with severe coronary and peripheral arterial disease. This will allow us to obtain information about diseases that cause inflammation in the heart and blood vessels. On the day of the procedure, at least 2 hours before the surgery, consented study participants will be injected with either the LUMISIGHT or saline. Following the injection, study participants will be monitored and observed for 30 minutes for any allergic reactions. Study participants will then undergo the standard of care surgery for their clinical care. During the procedure, surgeon will take out blocked pieces of subjects' blood vessel for clinical care. The investigators will get these discarded pieces and image it with a special imaging system developed by the Tearney Lab. This system uses a thin tube with a light-based camera (called Optical Coherence Tomography-Near Infra Red Fluorescence or OCT-NIRF) to capture detailed images.
Interventions
DRUGPegulicianine
Pegulicianine (LUMISIGHT) Inflammatory activity
OTHERPlacebo
Control group for the study
Sponsors
Massachusetts General Hospital
National Institutes of Health (NIH)
National Heart, Lung, and Blood Institute (NHLBI)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Must have an established diagnosis of severe carotid or peripheral arterial disease (ischemic or aneurysmal) requiring surgery and be sufficiently healthy to undergo surgery * Must be age of 18 years or older * Must be able to give informed consent * Women with childbearing potential must have a negative pregnancy test * Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m2 (mild renal impairment
Exclusion criteria
* History of allergic reaction to oral or intravenous contrast agents * History of allergic reaction to polyethylene glycol (PEG) * History of allergic or anaphylactic reactions * Participants who have taken an investigational drug within 14 days of enrollment. * Participants with hemodynamic instability * Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) \<60ml/min/1.73 m2) * Pregnant or lactating females * Participants 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 active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, COPD or asthma requiring hospitalization within the past 12 months, or psychiatric illness/social situations that would limit compliance with study requirements
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Demonstrate lumisight fluorescence activity in lumisight cohort vs controls | 2-6 hours | Mean difference in plaque for fluorescence ratio to show that fluorescence in the Lumisight cohort is 2 fold greater than that of the control |
Countries
United States
Contacts
CONTACTAnita Chung
PRINCIPAL_INVESTIGATORGuillermo Tearney, MD, PhD
Massachusetts General Hospital
Outcome results
None listed