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A Prospective, Multicenter, Randomized Controlled Trial to Investigate the Value of Coronary CT Angiography in the Understanding and Management of Coronary Calcium (The Optimal Trial)

StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Eligibility criteria expanded, about 22 words Secondary endpoints: details revised at 14 of 22 entries · Site details revised at 4 of 14 sites · Collaborators revised (2) · 1 more Show 4 more changesShow less
    • Secondary endpoints: details revised at 14 of 22 entries
    • Site details revised at 4 of 14 sites
    • Collaborators revised (2)
    • Publications: details revised at 5 of 5 entries
  2. Site contacts updated at 1 of 14 sites Collaborators expanded, about 9 wordsv9 Show 1 more changeShow less
    • Collaborators expanded, about 9 words

    See this version in full on ClinicalTrials.gov ↗

  3. Site details revised at 1 of 14 sitesv8
  4. Study sites: 13 to 14v7
  5. Site details revised at 2 of 13 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 8 to 13v5
  2. Study sites: 2 to 8v4
  3. Study sites: 1 to 2 Start date: Dec 23, 2025 to Dec 22, 2025v3 Show 1 more changeShow less
    • Start date: Dec 23, 2025 to Dec 22, 2025
  4. Trial status: Not Yet Recruiting to Recruiting Study sites: 0 to 1 · Start date changed from estimate of Dec 15, 2025 to Dec 23, 2025v2 Show 2 more changesShow less
    • Study sites: 0 to 1
    • Start date changed from estimate of Dec 15, 2025 to Dec 23, 2025
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT07286578
Lead Sponsor Fundación EPIC
Collaborators: Cardiovascular Research Foundation, New York, St George's University Hospitals NHS Foundation Trust
Conditions Cardiovascular Diseases, Myocardial Ischemia, Heart Diseases, Arteriosclerosis, Arterial Occlusive Diseases, Vascular Diseases, Coronary Artery Disease
Enrollment 700 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov