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ICGA for Vascular Embolism After Hyaluronic Acid Injection

5 maggio 2026 aggiornato da: Chongli Yu

Value of Indocyanine Green Angiography for Real-Time Assessment of Vascular Embolism Following 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.

Panoramica dello studio

Stato

Completato

Condizioni

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Effettivo)

19

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

    • Beijing Municipality
      • Beijing, Beijing Municipality, Cina, 100144
        • Plastic Surgery Hospital, Chinese Academy of Medical Sciences

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

N/A

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population consists of consecutive patients treated at the Center for Wound Repair and Tissue Regeneration, Plastic Surgery Hospital, Chinese Academy of Medical Sciences, for facial vascular embolism following hyaluronic acid injection between July 2025 and March 2026. Participants will be identified retrospectively from existing medical records, indocyanine green angiography imaging data, treatment records, and follow-up documentation generated during routine clinical care.

Descrizione

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.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy
Lasso di tempo: 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.
Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Median Within-Participant Change in ICGA-Derived Time to Peak From Before to After Initial Rescue Therapy
Lasso di tempo: 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.
Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
Median Within-Participant Change in ICGA-Derived Curve Ingress From Before to After Initial Rescue Therapy
Lasso di tempo: 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.
Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

1 luglio 2025

Completamento primario (Effettivo)

30 marzo 2026

Completamento dello studio (Effettivo)

30 marzo 2026

Date di iscrizione allo studio

Primo inviato

28 aprile 2026

Primo inviato che soddisfa i criteri di controllo qualità

5 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

5 maggio 2026

Ultimo verificato

1 luglio 2025

Maggiori informazioni

Termini relativi a questo studio

Altri numeri di identificazione dello studio

  • 2026042018584440

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

INDECISO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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