ACTIVE_NOT_RECRUITING

Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Prospective Comparison of ICG Microangiography and Conventional Angiography in Severe Frostbite

Quick Facts

Study Start:2023-02-03
Study Completion:2025-09-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT05777590

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Adult (\>18 years old) patients
  2. 2. Diagnosed with severe frostbite by conventional angiography
  3. 3. Undergoing thrombolysis with catheter directed lytics
  4. 4. Clinically sober at the time of consent
  5. 5. Cognitively able to provide consent as determined by clinician's best judgement
  6. 6. Normal kidney function (GFR \>60)
  1. 1. Pregnant. Pregnancy will be determined by standard of care pregnancy test performed on all female frostbite patients who are receiving lytics.
  2. 2. Iodine allergy.

Contacts and Locations

Principal Investigator

Alexandra Lacey, MD
PRINCIPAL_INVESTIGATOR
Regions Hospital

Study Locations (Sites)

Regions Hospital
Saint Paul, Minnesota, 55101
United States

Collaborators and Investigators

Sponsor: HealthPartners Institute

  • Alexandra Lacey, MD, PRINCIPAL_INVESTIGATOR, Regions Hospital

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-02-03
Study Completion Date2025-09-30

Study Record Updates

Study Start Date2023-02-03
Study Completion Date2025-09-30

Terms related to this study

Keywords Provided by Researchers

  • Frostbite
  • Angiogram
  • Indocyanine Green
  • ICG

Additional Relevant MeSH Terms

  • Frostbite