Is indocyanine green near infrared fluorescence imaging, using a handheld camera system, able to accurately evaluate and quantify the peripheral tissue perfusion in patients with peripheral arterial disease? Hypothetically, as indocyanine green goes…
ID
Bron
Aandoening
Peripheral arterial disease
Ondersteuning
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
Peripheral tissue perfusion expressed in drainage ratio of ICG. Drainage ratio is calculated by the fluorescence intensity value 5 minutes after ICG injection divided by the maximal fluorescence value multiplied by 100. We will also measure the Tmax, T1/2 and FT10 (fluorescence intensity value 10 seconds after injection).
Achtergrond van het onderzoek
Atherosclerosis in major (peripheral) vessels and the subsequent decreased arterial perfusion of extremities can cause ischemic pain, ischemic ulcers and can eventually lead to amputation. At present, Computed Tomography Angiography (CT-A) and X-ray contrast angiography (XA) are the most sensitive diagnostic modalities regarding PAD. While both are well able to diagnose macrovascular occlusive pathologies they lack the ability to adequately assess microvascular (skin) perfusion. This researchproject's focus is to bridge this gap using a promising new diagnostic instrument: NIR fluorescence imaging.
Doel van het onderzoek
Is indocyanine green near infrared fluorescence imaging, using a handheld camera system, able to accurately evaluate and quantify the peripheral tissue perfusion in patients with peripheral arterial disease?
Hypothetically, as indocyanine green goes through microcirculation, and the drainage of ICG is constantly measured by the NIR light camera, the actual tissue perfusion can be accurately quantified in a non-invasive way.
Onderzoeksopzet
Inclusion active
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
Patients diagnosed with peripheral arterial disease(PAD).
Patients planned for percutaneous transluminal angioplasty as a treatment for PAD
Patients planned for bypass surgery as a treatment for PAD
Patients planned for an amputation of a (part of) lower extremity as a treatment for PAD Age 18-80 years old
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
Allergy or hypersensitivity for natriumiodide, iodium or indocyanine green
Hyperthyroidism or autonomous thyroid adenoma
Pregnancy
Severely impaired liver function
Opzet
Deelname
Voornemen beschikbaar stellen Individuele Patiënten Data (IPD)
Opgevolgd door onderstaande (mogelijk meer actuele) registratie
Andere (mogelijk minder actuele) registraties in dit register
Geen registraties gevonden.
In overige registers
| Register | ID |
|---|---|
| NTR-new | NL7531 |
| CCMO | NL65455.058.18 |
| OMON | NL-OMON55609 |