ICGA for Vascular Embolism After Hyaluronic Acid Injection
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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
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Beijing Municipality
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Beijing, Beijing Municipality, Kina, 100144
- Plastic Surgery Hospital, Chinese Academy of Medical Sciences
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
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Median Within-Participant Change in ICGA-Derived Ingress Rate From Before to After Initial Rescue Therapy
Tidsramme: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
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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.
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Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
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Median Within-Participant Change in ICGA-Derived Time to Peak From Before to After Initial Rescue Therapy
Tidsramme: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
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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.
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Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
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Median Within-Participant Change in ICGA-Derived Curve Ingress From Before to After Initial Rescue Therapy
Tidsramme: Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
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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.
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Periprocedural: immediately before initial rescue therapy and immediately after completion of initial rescue therapy
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Samarbejdspartnere og efterforskere
Sponsor
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Andre undersøgelses-id-numre
- 2026042018584440
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
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