Clinical trial

Prospective Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite

Name
A22-321
Description
Severe frostbite injury is a significant cause of morbidity in northern climates. Minnesota has some of the highest numbers of severe frostbite injuries in North America. As a result, Regions Hospital has the best opportunity to study this disease process and improve outcomes for frostbite patients. The diagnostic methods for severe frostbite injury vary from institution to institution and there is no standard practice. Commonly utilized methods include conventional angiography, Technetium 99 triple phase bone scans, SPECT studies, Indocyanine Green microangiography, and doppler studies. The proposed pilot study aims to directly compare conventional angiography imaging to ICG microangiography in adult patients with severe frostbite. Severe frostbite is defined as 4th degree: frostbite resulting in vascular occlusion and tissue ischemia. Both imaging modalities have been used for the diagnosis and monitoring of severe frostbite injury but there has never been a study directly comparing these two imaging modalities.
Trial arms
Trial start
2023-02-03
Estimated PCD
2025-03-31
Trial end
2025-03-31
Status
Recruiting
Treatment
Indocyanine Green Angiogram
Angiogram using ICG dye the occurs directly after conventional angiogram in assessment of frostbite patients undergoing thrombolysis
Other names:
ICG
Size
20
Primary endpoint
Assessment of Angiography and ICG microangiography imaging demonstrating ischemic tissue present in severe frostbite scored by Hennepin Frostbite Score.
Through study completion, an average of 2 years
Eligibility criteria
Inclusion Criteria: 1. Adult (\>18 years old) patients 2. Diagnosed with severe frostbite by conventional angiography 3. Undergoing thrombolysis with catheter directed lytics 4. Clinically sober at the time of consent 5. Cognitively able to provide consent as determined by clinician's best judgement 6. Normal kidney function (GFR \>60) Exclusion Criteria: 1. Pregnant. Pregnancy will be determined by standard of care pregnancy test performed on all female frostbite patients who are receiving lytics. 2. Iodine allergy.
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 20, 'type': 'ESTIMATED'}}
Updated at
2024-02-26

1 organization

1 product

1 indication

Indication
Frostbite