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Prospektivní, multicentrická, randomizovaná kontrolovaná studie zkoumající hodnotu koronární CT angiografie v pochopení a léčbě koronárního kalcia (The Optimal Trial)

9. listopadu 2026 aktualizováno: Fundación EPIC

Prospektivní, multicentrická, randomizovaná kontrolovaná studie zaměřená na zkoumání hodnoty koronární CT angiografie v pochopení a léčbě koronárního kalcifikace

The OPTIMAL randomized clinical trial has been designed to compare two imaging strategies and to test the hypothesis that a calcium modification strategy informed by coronary CT angiography (CCTA) will improve procedural efficiency and effectiveness compared with the current standard of care (IVUS-guided PCI) while achieving similar clinical outcomes in patients with hemodynamically significant calcified coronary artery disease.

Přehled studie

Postavení

Nábor

Podmínky

Intervence / Léčba

Detailní popis

The OPTIMAL Trial is a prospective, multicenter, randomized controlled study evaluating whether a coronary CT angiography (CCTA)-guided calcium modification strategy can improve the treatment of patients with hemodynamically significant, calcified coronary artery disease undergoing percutaneous coronary intervention (PCI).

Seven hundred patients with flow-limiting stenosis (FFRCT ≤0.80) and moderate-to-severe calcification on CCTA will be randomized 1:1 to either CCTA-guided or intravascular ultrasound (IVUS)-guided calcium modification. The study includes two co-primary endpoints: (1) superiority in final minimal stent area assessed by IVUS, and (2) non-inferiority in 12-month target vessel failure (cardiac death, target-vessel myocardial infarction, or ischemia-driven revascularization).

CCTA-guided strategy uses advanced calcium characterization to inform pre-procedural planning and selection of plaque modification techniques. IVUS-guided strategy follows contemporary intravascular imaging-based criteria for plaque preparation and PCI optimization.

The trial aims to determine whether leveraging non-invasive CT-based calcium assessment can enhance procedural efficiency and stent results while maintaining clinical safety comparable to IVUS-guided PCI.

Typ studie

Intervenční

Zápis (Odhadovaný)

700

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní kontakt

  • Jméno: CAROLINA FOCELLA
  • Telefonní číslo: 001 917 753 6695
  • E-mail: cfocella@crf.org

Studijní záloha kontaktů

Studijní místa

      • Aalst, Belgie, 9300
        • Nábor
        • Azorg Hospital, Aalst
      • Leicester, Spojené království
        • Nábor
        • University Hospitals of Leicester NHS Trust
      • London, Spojené království
        • Nábor
        • St Bartholomew's Hospital (Barts Health NHS Trust)
      • London, Spojené království
        • Nábor
        • St George's University Hospitals NHS Foundations Trust
        • Kontakt:
          • James Spratt, MD, PhD
      • London, Spojené království
        • Nábor
        • Guys & St Thomas Nhs Foundation Trust
      • Newcastle, Spojené království
        • Zatím nenabíráme
        • Newcastle Hospitals NHS Foundations Trust
      • Oxford, Spojené království
        • Zatím nenabíráme
        • John Radcliffe Hospital, Oxford
    • Massachusetts
      • Boston, Massachusetts, Spojené státy, 02115
        • Zatím nenabíráme
        • Bringham and Women's Hospital
    • Minnesota
      • Minneapolis, Minnesota, Spojené státy, 55407
        • Nábor
        • Minneapolis Heart Institute
    • New Jersey
      • Jersey City, New Jersey, Spojené státy, 08837
        • Zatím nenabíráme
        • HACKENSACK MERIDIAN HEALTH, Inc
    • New York
      • New York, New York, Spojené státy, 14853
        • Zatím nenabíráme
        • Weill Medical College of Cornell University
      • New York, New York, Spojené státy, 10032
        • Nábor
        • NewYork-Presbyterian/Weill Cornell Medical Center
      • Barcelona, Španělsko, 08035
        • Nábor
        • Hospital Universitari Vall Hebron
      • León, Španělsko
        • Nábor
        • Hospital Universitario de Leon
      • Madrid, Španělsko, 28046
        • Nábor
        • Hospital Universitario La Paz

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

18 let až 85 let (Dospělý, Starší dospělý)

Přijímá zdravé dobrovolníky

Ne

Pohlaví způsobilá ke studiu

Všechno

Popis

Inclusion Criteria:

  • The subject must be at least 18 years of age and younger than 85 years old
  • Subject must have evidence of myocardial ischemia (e.g., stable angina, silent ischemia (ischemia in the absence of chest pain or other anginal equivalents), unstable angina, or acute myocardial infarction) suitable for PCI. Patients with a clinical indication for revascularization presenting with stable coronary artery disease or stabilized acute coronary syndrome defined as follows unstable angina (Braunwald class IB, IC, IIB, IIC, IIIB, IIIC), patients with NSTEMI without high-risk features such as recurrence of chest pain, ST-segment depression>1mm in ≥6 leads plus STsegment elevation in aVR, life-threatening arrhythmias, mechanical complications of MI, resuscitated cardiac arrest, GRACE risk score>140.
  • All target vessels must have reference vessel diameter (visually assessed by CCTA) ≥ 2.5 mm
  • Subject must provide written informed consent before any study-related procedure

Exclusion Criteria:

  • STEMI as the clinical presentation.
  • Uncontrolled or recurrent ventricular tachycardia.
  • Hemodynamic instability.
  • Hemodialysis or peritoneal dialysis.
  • Left main coronary artery stenosis > 50%
  • Atrial fibrillation, flutter, or arrhythmias during CT acquisition.
  • Previous PCI in the target vessel or CABG.
  • BMI ≥ 40 kg/m2
  • Insufficient CT quality assessed by the Core lab.
  • Comorbidity with life expectancy ≤ 2 years.
  • Planned major cardiac or non-cardiac surgery within 24 months after the index procedure Note: Major surgery is any invasive operative procedure in which an extensive resection is performed, e.g., a body cavity is entered, organs are removed, or normal anatomy is altered. Note: Minor surgery is an operation on the superficial structures of the body or a manipulative procedure that does not involve a serious risk. Planned minor surgery is not excluded.
  • The subject has received a solid organ transplant that is functioning or is active on a waiting list for any solid organ transplants with expected transplantation within 24 months.
  • The subject receives immunosuppressant therapy or has known immunosuppressive or severe autoimmune disease that requires chronic immunosuppressive therapy (e.g., human immunodeficiency virus, systemic lupus erythematosus, etc.). Note: corticosteroids are not included as immunosuppressant therapy.
  • The subject has previously received or is scheduled to receive radiotherapy to a coronary artery (vascular brachytherapy) or the chest/mediastinum.
  • Subject has a platelet count <100,000 cells/mm3 or >700,000 cells/mm3.
  • The subject has a documented or suspected hepatic disorder as defined as cirrhosis or Child-Pugh ≥ Class B.
  • The subject has a history of bleeding diathesis or coagulopathy or has had a significant gastro-intestinal or significant urinary bleed within the past six months. The subject has had a cerebrovascular accident or transient ischemic neurological attack (TIA) within the past six months, or any prior intracranial bleed, or any permanent neurologic defect, or any known intracranial pathology (e.g., aneurysm, arteriovenous malformation, etc. The subject has a life expectancy <2 years for any non-cardiac cause.
  • Subject is currently participating in another investigational drug or device clinical study.
  • Pregnant or nursing subjects and those who plan pregnancy in the period up to 2 years following index procedure. Female subjects of child-bearing potential must have a negative pregnancy test done within 7 days prior to the index procedure per site standard test.
  • Presence of other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation or to comply with follow-up requirements, or impact the scientific soundness of the clinical investigation results.
  • Unable to provide written informed consent (IC).

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Léčba
  • Přidělení: Randomizované
  • Intervenční model: Paralelní přiřazení
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: CT-guide calcium modification strategy

Pre-procedural CT will be used to determine lesion characteristics.

CT will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent

Aktivní komparátor: IVUS-guide calcium modification strategy

Pre-procedural IVUS will be used to determine lesion characteristics.

IVUS will be used to determine lesion characteristics and post-procedural IVUS to confirm correct implantation of stent

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Demonstrate that CT-guided calcium modification results in a superior final MSA Minimal Stent Area (MSA) - Imaging Endpoint (Superiority)
Časové okno: Perioperative/Periprocedural

Final post-PCI minimal stent area per target lesion, measured by independent core laboratory using intravascular ultrasound (IVUS). Assesses whether CT-guided calcium modification results in superior stent expansion compared with IVUS-guided PCI.

Perioperative/Periprocedural
Target Vessel Failure (TVF) - Clinical Endpoint (Non-Inferiority)
Časové okno: 12 months

Composite of cardiac death, target-vessel myocardial infarction (TV-MI), or ischemia-driven target vessel revascularization (ID-TVR). TV-MI and ID-TVR are defined according to ARC-2 and the Fourth Universal Definition of MI.

12 months

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Procedural efficiency: Procedure time
Časové okno: During PCI

Time from first angiogram to final angiogram

During PCI
Procedural efficiency:Radiation dose-area product
Časové okno: During PCI

Dose-area product (DAP) recorded during PCI.

During PCI
Procedural efficiency: Contrast volume
Časové okno: During PCI

Total contrast volume (mL) used during PCI.IVUS-Derived Mechanistic Endpoints (Core Lab)

During PCI
Procedural Efficiency: Stent Area on Immediate Post-Stent IVUS
Časové okno: Perioperative/Periprocedural

MSA prior to any final IVUS-guided optimization.

Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Original Minimal Lumen Area (MLA)
Časové okno: Perioperative/Periprocedural

Stent area at the co-registered site of the baseline MLA.

Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Arc
Časové okno: Perioperative/Periprocedural

Stent area measured at the co-registered IVUS site with maximal calcium arc

Perioperative/Periprocedural
Procedural Efficiency: Final Stent Area at Site of Maximum Calcium Density
Časové okno: Perioperative/Periprocedural

Stent area measured at the co-registered CT-identified region of greatest Hounsfield Unit (HU) calcium density.

Perioperative/Periprocedural
Procedural Efficiency: Relative Stent Expansion
Časové okno: Perioperative/Periprocedural

Percentage expansion calculated as:

MSA ÷ mean distal reference lumen area × 100.

Perioperative/Periprocedural
Procedural Efficiency: Number of Calcium Fractures
Časové okno: Post-modification, pre-stent

Fractures identified on intermediary IVUS after calcium modification.

Post-modification, pre-stent
Procedural Efficiency: Change in Plaque Attenuation
Časové okno: Post-modification, pre-stent

Change in IVUS plaque characteristics following calcium modification.Angiographic Endpoints

Post-modification, pre-stent
Procedural Efficiency: Final Minimal Lumen Diameter
Časové okno: Perioperative/Periprocedural

Minimum lumen diameter by quantitative coronary angiography (QCA)

Perioperative/Periprocedural
Procedural Efficiency: Final Percent Diameter Stenosis
Časové okno: Perioperative/Periprocedural

Percent stenosis of treated lesion after PCI, by QCA

Perioperative/Periprocedural
Procedural Efficiency: Final TIMI Flow Grade
Časové okno: Perioperative/Periprocedural

Target vessel flow graded 0-3 based on TIMI criteria. Thrombolysis In Myocardial Infarction (TIMI) Flow Grade is a 0-3 angiographic scale used during coronary angiography to describe how well blood is flowing through a coronary artery.TIMI 0 No perfusion, TIMI 1 Penetration without perfusion, TIMI 2 Partial perfusion TIMI 3 Complete perfusion (normal flow)

Perioperative/Periprocedural
Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure

According to Coronary dissection (NHLBI classification)

Day of procedure
Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure

According to Coronary perforation (Ellis classification)

Day of procedure
Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure

Slow-flow / no-reflow

Day of procedure
Procedural Efficiency: Angiographic Complications
Časové okno: Day of procedure

Side branch closure (TIMI 0-1)

Day of procedure
Clinical & Safety Outcomes: Procedural Success
Časové okno: Perioperative/Periprocedural

Final stenosis <30%, TIMI 3 flow, no angiographic complications, and no in-hospital major adverse cardiac events (MACE).

Perioperative/Periprocedural
Clinical & Safety Outcomes: Periprocedural Myocardial Infarction (Type 4a MI)
Časové okno: Day 0-1

Defined by ARC-2 and 4th Universal Definition of MI (troponin criteria + evidence of ischemia).

Day 0-1
Clinical & Safety Outcomes: Stent Thrombosis
Časové okno: Up to 12 months

Definite or probable stent thrombosis according to ARC-2 definitions.

Up to 12 months
Patient-Reported Outcomes: Residual Angina (SAQ-7 Angina Frequency)
Časové okno: 12 months

Residual angina defined as SAQ-7 Angina Frequency score <100. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently

12 months
Patient-Reported Outcomes: Change in Angina (SAQ-7)
Časové okno: Baseline to 12 months

Change in angina frequency domain score; positive values indicate improvement. Angina frequency represent how often a patient has had angina (chest pain/discomfort) over a recent recall period. Reported as a 0 to 100 scale: 100 = no angina; 0 = angina occurring very frequently

Baseline to 12 months

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Spolupracovníci

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

22. prosince 2025

Primární dokončení (Odhadovaný)

15. prosince 2029

Dokončení studie (Odhadovaný)

1. ledna 2030

Termíny zápisu do studia

První předloženo

28. listopadu 2025

První předloženo, které splnilo kritéria kontroly kvality

12. prosince 2025

První zveřejněno (Aktuální)

16. prosince 2025

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

10. listopadu 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

9. listopadu 2026

Naposledy ověřeno

1. listopadu 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další identifikační čísla studie

  • EPIC46-THE OPTIMAL TRIAL

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .