Trial Radar IA | ||
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Lo studio clinico NCT07020858 (FACT-2) per Chronic Total Occlusion (CTO), Sindrome coronarica cronica è in arruolamento. Consulti la vista a schede del Radar degli Studi Clinici e gli strumenti di scoperta IA per tutti i dettagli. Oppure, ponga pure una domanda qui. | ||
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FAPI Imaging Predicts Adverse Cardiac Events in Chronic Total Occlusion (FACT-2) 470 Non invasivo Osservazionale
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La sperimentazione clinica NCT07020858 (FACT-2) è uno studio osservazionale per Chronic Total Occlusion (CTO), Sindrome coronarica cronica, attualmente in arruolamento. Avviato il 15 aprile 2025, prevede di arruolare 470 partecipanti. Sotto la guida di Lin Zhao, dovrebbe concludersi entro il 15 marzo 2027. I dati più recenti da ClinicalTrials.gov sono stati aggiornati l'ultima volta il 19 giugno 2025.
Sommario breve
Prospective, observational, single-center cohort study
Hypothesis Higher myocardial FAPI uptake in CTO patients predicts a greater incidence of major adverse cardiovascular events (MACE) within 12 months after PCI. FAPI PET/CT imaging is associated with plaque vulnerability features and may serve as a non-invasive marker for fibrotic activity and adverse cardiac remodeling.
Inclusion Criteria
- Age ≥ 18 years
- Pr...
Descrizione dettagliata
Chronic total occlusion (CTO) of coronary arteries represents one of the most complex and challenging subsets of coronary artery disease and is associated with increased cardiovascular risk. While percutaneous coronary intervention (PCI) for CTO lesions has evolved substantially due to advances in imaging, devices, and operator experience, long-term prognostic evaluation remains suboptimal. In particular, no imaging ...Mostra di più
Titolo ufficiale
The Value of FAPI Imaging for the Prediction of Adverse Cardiovascular Events in Chronic Total Occlusion of Coronary Artery Disease (FACT-2 Trial)
Patologie
Chronic Total Occlusion (CTO)Sindrome coronarica cronicaPubblicazioni
Articoli scientifici e documenti di ricerca pubblicati su questo studio clinico:Altri ID dello studio
- FACT-2
- 2025-ke-415
Numero NCT
Data di inizio (effettiva)
2025-04-15
Ultimo aggiornamento pubblicato
2025-06-19
Data di completamento (stimata)
2027-03-15
Arruolamento (previsto)
470
Tipo di studio
Osservazionale
Stato
In arruolamento
Parole chiave
Coronary Heart Disease
Major adverse cardiovascular events (MACE)
Plaque vulnerability
Optical coherence tomography (OCT)
Fibroblast activation protein inhibitor (FAPI)
Percutaneous coronary intervention (PCI)
Major adverse cardiovascular events (MACE)
Plaque vulnerability
Optical coherence tomography (OCT)
Fibroblast activation protein inhibitor (FAPI)
Percutaneous coronary intervention (PCI)
Bracci / Interventi
| Gruppo/Braccio di partecipanti | Intervento/Trattamento |
|---|---|
Patients with at least one untreated CTOat basal angiography Total occlusion in any major coronary vessel or relevant side branches \[reference vessel diameter \>2.5 mm or as judged by two independent interventional cardiologists\], with TIMI 0 in the distal segment and at least 3 months old | FAPl lmaging Studies have shown that imaging with radionuclide-labeled fibroblast activation protein inhibitor (FAPl) is a reliable technique for detecting myocardial fibrosis and activated CFs in arteries. Preliminary evidence suggests that FAPl imaging can assess plaque characteristics and the status of myocardial fibrosis in various cardiovascular diseases. |
Esito primario
Esito secondario
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
Incidence of Major Adverse Cardiovascular Events (MACE) | MACE is defined as a composite of cardiac death, myocardial infarction, stroke, and urgent revascularization (including in-stent restenosis, target lesion revascularization, or target vessel revascularization). Events will be assessed through clinical follow-up and hospital record review. | 12 months after percutaneous coronary intervention (PCI) |
| Misure di esito | Descrizione della misura | Arco temporale |
|---|---|---|
All-Cause Mortality | Death from any cause, including cardiovascular and non-cardiovascular causes, occurring within 12 months after the index PCI procedure. | 12 months post-PCI, verified through national death registry and hospital records. |
Change in Quality of Life | Assessed using the Seattle Angina Questionnaire (SAQ). Outcome domains include angina frequency, physical limitation, and treatment satisfaction. Comparison is made between baseline and 12-month follow-up. | At baseline and 12 months post-PCI. |
Repeat Percutaneous Coronary Intervention (Repeat PCI) | Incidence of repeat PCI due to recurrent or new coronary lesions within 12 months, categorized as:
In-Stent Restenosis (ISR): ≥50% luminal narrowing in the original stented segment, with or without symptoms.
Target Lesion Revascularization (TLR): Reintervention at the original stent site due to restenosis or thrombosis.
Target Vessel Revascularization (TVR): Intervention in the same coronary artery, but outside the original stent site.
De Novo Lesion: New lesion in a vessel not treated during the index PCI. Confirmation based on follow-up angiography. | Within 12 months following the index PCI procedure.Angiographic confirmation |
Assistente alla partecipazione
Criteri di eleggibilità
Età idonea
Adulto, Adulto anziano
Età minima
18 Years
Sessi idonei
Tutti
- Age ≥18 years.
- Confirmed diagnosis of ≥1 untreated chronic total occlusion (CTO):Defined as complete occlusion of a major coronary artery or relevant collateral (reference vessel diameter ≥2.5 mm or confirmed by two independent interventional cardiologists), with TIMI flow grade 0 in the distal segment and duration ≥3 months.Preoperatively confirmed by coronary angiography or coronary computed tomography angiography (CTCA).
- Willingness to undergo FAPI-PET imaging and receive PCI under imaging guidance.
- Ability to provide written informed consent.
- Contraindications to antiplatelet therapy: Allergy or intolerance to aspirin, clopidogrel, or ticagrelor.
- Severe liver dysfunction: Liver function parameters exceeding 3× the upper limit of normal.
- Severe chronic kidney disease: Estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m².
- Life expectancy <1 year due to non-cardiovascular comorbidities.
- Pregnancy or women of childbearing potential (unless surgically sterile or using contraception).
Lin ZhaoParte responsabile dello studio
Lin Zhao, Promotore-investigatore, Cheif of Cardiovascular department, Beijing Chao Yang Hospital
Contatti principali dello studio
Contatto: Shengwen Yang, Dr, +8601085231480, [email protected]
Contatto: Bin Tu, +8601085231480, [email protected]
1 Centri dello studio in 1 paesi
Beijing Municipality
Beijing Chaoyang Hospital，Capital Medical University，Beijing，China, Beijing, Beijing Municipality, 100020, China
In arruolamento