Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

RECRUITING 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)

NCT07286578 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 700 participants
Start Date 2025-12-22
Est. Completion 2030-01-01
Phase NA

Sponsor

Fundación EPIC

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT07286578

The ClinicalTrials.gov registry entry for NCT07286578 describes a study currently listed as recruiting. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 700 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Fundación EPIC, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT07286578 reports 13 study locations spanning 5 distinct geographic areas — top geographies include Other, New York, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT07286578?

This trial is sponsored by Fundación EPIC, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial