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NCT07286578 · ClinicalTrials.gov registry record · NA
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)
A NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by Fundación EPIC.
- Recruiting
- Registry status
- NA
- Development phase
- 700
- Enrollment target
- 13
- Study locations
NCT07286578: Recruiting NA study of Cardiovascular Diseases and Coronary Artery Disease, sponsored by Fundación EPIC.
NCT07286578 is a NA study of Cardiovascular Diseases and Coronary Artery Disease that is actively recruiting participants, run by Fundación EPIC. The registered enrollment target is 700 participants, below the 26,972-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (97% lower). The trial reports 13 study locations across 5 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT07286578, a NA study of Cardiovascular Diseases and Coronary Artery Disease, is actively recruiting participants, sponsored by Fundación EPIC.
- RECRUITING
- Registry status
- NA
- Development phase
- 700 participants
- Enrollment target
- 13
- Study locations
Study Summary
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.
Primary Outcome
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.
Conditions Studied
Interventions
- DEVICE CT(Computed Tomography) guided Percutaneous Coronary Intervention
- DEVICE IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention
Study Locations (13)
Other
- Hospital Universitari Vall Hebron - Barcelona
- Hospital Universitario de Leon - León
- Hospital Universitario La Paz - Madrid
- University Hospitals of Leicester NHS Trust - Leicester
- St Bartholomew's Hospital (Barts Health NHS Trust) - London
- St George's University Hospitals NHS Foundations Trust - London
- Newcastle Hospitals NHS Foundations Trust - Newcastle
- John Radcliffe Hospital, Oxford - Oxford
New York
- Columbia University Irving Medical Center/NewYork-Presbyterian Hospital - New York
- Weill Medical College of Cornell University - New York
Massachusetts
- Bringham and Women's Hospital - Boston
Minnesota
- Minneapolis Heart Institute - Minneapolis
New Jersey
- HACKENSACK MERIDIAN HEALTH, Inc - Jersey City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 700 participants |
| Start Date | 2025-12-22 |
| Est. Completion | 2030-01-01 |
| Phase | NA |
What NCT07286578 shows while recruiting
NCT07286578 is an interventional study that assigns participants to a tested intervention. The registered 700 participants enrollment target is mid-sized for trials with a published cap, below the 26,972-participant average among 300 other Cardiovascular Diseases trials with a reported enrollment target (97% lower).
The record links to 7 conditions, with Cardiovascular Diseases appearing as the primary indexed condition, and to 2 interventions - of which CT(Computed Tomography) guided Percutaneous Coronary Intervention is the first listed.
NCT07286578 lists 13 locations in 5 states (Other, New York, Massachusetts).
Frequently Asked Questions
What is clinical trial NCT07286578 about?
NCT07286578 is a clinical study titled "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)". 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-g...
What is the current status of trial NCT07286578?
This trial is currently recruiting. It is a NA study. The enrollment target is 700 participants. The study started on 2025-12-22. Estimated completion is 2030-01-01.
What conditions does trial NCT07286578 study?
This clinical trial studies the following conditions: Cardiovascular Diseases, Coronary Artery Disease, Heart Diseases, Vascular Diseases, Myocardial Ischemia.
What interventions are being tested in trial NCT07286578?
The interventions under investigation include: CT(Computed Tomography) guided Percutaneous Coronary Intervention (DEVICE), IVUS (Intravascular Ultrasound) guided Percutaneous Coronary Intervention (DEVICE).
Who is sponsoring clinical trial NCT07286578?
This trial is sponsored by Fundación EPIC, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07286578 being conducted?
This trial has 13 study locations across Massachusetts, Minnesota, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Cardiovascular Diseases
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07286578's enrollment target sits among peer trials
700 78th of 300 higher than 222 of 300 other Cardiovascular Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Cardiovascular Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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