Completed

NCT Number: NCT07581652

ICGA for Vascular Embolism After Hyaluronic Acid Injection

Facial vascular embolism following hyaluronic acid injection is a rare but potentially serious complication that may lead to tissue ischemia, necrosis, and scarring. Early assessment of local tissue perfusion is important for evaluating treatment response and predicting clinical outcomes.

This retrospective observational study aims to evaluate whether indocyanine green angiography (ICGA) can provide objective, real-time information on tissue perfusion in patients with facial vascular embolism after hyaluronic acid injection. The study will review existing medical records, ICGA imaging data, and follow-up information from patients treated at a single center. The main question is whether ICGA findings before and after initial rescue therapy can help assess early perfusion recovery and identify patients who may require additional intervention or develop persistent tissue damage.

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Key information

Conditions

Embolism Arterial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Plastic Surgery Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, 100144, China

About this study

This is a single-center, retrospective, observational study. The study will use existing clinical data generated during prior routine care, including medical records, ICGA imaging data, and follow-up documentation. No additional examinations, treatments, or study-specific follow-up visits will be introduced.

The study focuses on patients with facial vascular embolism following hyaluronic acid injection who underwent ICGA assessment before and immediately after initial rescue therapy. ICGA was performed as part of prior clinical evaluation to visualize local tissue perfusion in real time. Quantitative perfusion-related parameters were obtained using imaging analysis software.

The analysis will compare ICGA-based perfusion changes within the same patient before and after initial rescue therapy. The study will also explore whether baseline perfusion status and early perfusion recovery are associated with subsequent clinical management and tissue outcomes. Patients may be descriptively stratified according to whether additional intervention was required after initial rescue therapy.

All data will be collected retrospectively and de-identified before analysis. The study does not alter previous clinical decision-making and does not expose participants to additional physiological risk. The main study-related risk is potential loss of confidentiality, which will be minimized through de-identification, restricted access to study data, and secure data storage.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

History of facial hyaluronic acid injection.
Clinical diagnosis of facial vascular embolism after hyaluronic acid injection, with symptoms or signs such as pain, skin color change, livedo-like discoloration, delayed capillary refill, or tissue ischemia.
Received initial rescue treatment at the study center.
Had indocyanine green angiography imaging performed before and immediately after initial rescue treatment as part of routine clinical care.
Had sufficient medical records and follow-up information available to assess subsequent treatment and tissue outcomes.

Exclusion criteria

Incomplete indocyanine green angiography imaging data.
Insufficient medical records or follow-up information to assess the main study outcomes.
Missing key clinical information needed for study analysis.
Duplicate records or records with concerns about data reliability.
The patient or legal representative explicitly objected to the use of historical clinical data for this study, if applicable under local ethics requirements.

Treatment and study plan

Indocyanine Green Angiography Assessment

Other

Indocyanine green angiography was performed as part of prior routine clinical evaluation to assess local tissue perfusion in patients with facial vascular embolism following hyaluronic acid injection. In this retrospective observational study, existing ICGA imaging data obtained before and immediately after initial rescue therapy will be reviewed and analyzed. No additional ICGA examination will be performed for research purposes.

Primary outcomes

Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy

Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy

Ingress rate is an indocyanine green angiography-derived perfusion parameter representing the maximum slope of fluorescence intensity increase. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in ingress rate, calculated as the post-treatment value minus the pre-treatment value.
Median Within-Participant Change in ICGA-Derived Time to Peak From Before to After Initial Rescue Therapy

Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy

Time to peak is an indocyanine green angiography-derived perfusion parameter representing the time interval from first visible fluorescence to peak fluorescence intensity. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in time to peak, calculated as the post-treatment value minus the pre-treatment value.
Median Within-Participant Change in ICGA-Derived Curve Ingress From Before to After Initial Rescue Therapy

Time frame: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy

Curve ingress is an indocyanine green angiography-derived perfusion parameter representing the area under the fluorescence-time curve from the start of fluorescence increase to peak fluorescence intensity. It will be measured immediately before initial rescue therapy and immediately after completion of initial rescue therapy. The reported value will be the within-participant change in curve ingress, calculated as the post-treatment value minus the pre-treatment value.

Sponsors and collaborators

Lead sponsor

Chongli Yu

Other

Collaborators

The Plastic Surgery Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

Registry information

Official study title

Value of Indocyanine Green Angiography for Real-Time Assessment of Vascular Embolism Following Hyaluronic Acid Injection

Important dates

Study start: 2025
Primary completion: 2026
Study completion: 2026
First posted: May 12, 2026
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.