NCT06678594: CYCLOPES

Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification

Recruiting now Last updated 7 November 2024

What this trial tests

trial testing Calcium modification in Myocardial Ischaemia in 500 participants. Currently enrolling.

Timeline

24 September 2024

Primary endpoint
23 March 2026

23 March 2027

Quick facts

Lead sponsor	Royal College of Surgeons, Ireland
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	500
Start date	24 September 2024
Primary completion	23 March 2026
Estimated completion	23 March 2027
Sites	1 location across Ireland

Drugs / interventions tested

• Calcium modification

Conditions studied

• Myocardial Ischaemia — all drugs for Myocardial Ischaemia →
• Severely Calcified Coronary Stenoses — all drugs for Severely Calcified Coronary Stenoses →
• Coronary Calcification — all drugs for Coronary Calcification →

Sponsor

Royal College of Surgeons, Ireland

Who can join

18 and older, any sex, with Myocardial Ischaemia or Severely Calcified Coronary Stenoses. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

In this study, the doctors will follow a set of rules that is called an algorithm. An algorithm is a step-by-step approach that doctors use to guide them when making decisions about the best way to treat their patients. Algorithms are useful because they help doctors decide on the best treatment approach based on the patient's individual circumstances and the best medical evidence available. The algorithm that is being used in this study is called a calcium modification algorithm and it will guide doctors when deciding on the best way to modify or break up the calcium in coronary arteries.

In this study, we aim to prove that the calcium modification algorithm, described above, safely and effectively guides doctors on the best way to modify calcium in patients' coronary arteries. By doing so, it will help doctors in making decisions about patients' treatment during their procedure. It will also help standardise care for patients, so patients receive the same treatment no matter what hospital they are in or what doctor is treating them.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Workflow-based Framework to Aid with High-Definition Intravascular Ultrasound-Optimised Coronary Stenting: Introducing IVUS 123 Essentials.
   Walsh SJ, Cavalcante R, Croce K, Hanratty CG, et al · · 2026 · PMID 41674998 · DOI 10.15420/icr.2025.44
2. A Prospective, Multicenter, Open Label Study Investigating the Implementation of a Standardized Algorithm for Coronary CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES): Design and Rationale of the CYCLOPES Tri
   O'Callaghan D, Durand R, Hanratty CG, Cuisset T, et al · · 2026 · PMID 41408534 · DOI 10.1002/ccd.70424