Study to Image Inflammatory Activity of a Fluorescence Imaging Agent in Excised Human Artery Plaques
A legfontosabb adatok
- Hol
- Boston (Egyesült Államok)A helyszín megnézése
- Fázis
- Korai 1. fázis
Helyszínek itt: Egyesült Államok
- Massachusetts General HospitalBoston, Egyesült ÁllamokContact: Anita ChungNo longer taking part
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Massachusetts General Hospital
- Azonosító
- NCT06957821
- A regiszteradat frissítve
- 2026. november 10.
- Eredeti leírás
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.A teljes eredeti leírásKevesebb
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.
Bevonási feltételek: 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.
Kizáró feltételek: Participants who have taken an investigational drug within 14 days of enrollment; 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; 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 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; Any history of renal failure (estimated Glomerular Filtration Rate (eGFR) <60ml/min/1.73 m2); Participants with hemodynamic instability; Pregnant or lactating females.