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Standard Steps for Treating Calcium Build-up in Heart Arteries

Follows adults with calcium build-up in heart arteries during a procedure to modify it.

Key facts

Who runs it
Royal College of Surgeons, Ireland
Where
Dublin, IrelandSee the site
Trial code
Registry title
Implementation of a Standardized Algorithm for Coronary Calcification With Plaque Modification
Status
Recruiting
People taking part
500 people, planned
Started
24 Sept 2024
Expected to end
23 Mar 2027
Type of study
Observational
Treatments tested
  • Calcium modification
Record updated
7 November 2024

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with heart muscle poor blood supply and a hard, calcium-rich narrowing in a heart artery that can be treated with a stent procedure (PCI).

Age
18 years or older.
Sex
All sexes can join.
Disease stage
A moderately to severely calcified narrowing in a native heart artery, with at least 70% narrowing by visual estimate, in a vessel 2.5 mm to 4.0 mm wide, with normal blood flow (TIMI 3), and a guidewire that can pass through it.
Biomarker or test result
Calcium confirmed on angiography or on high-definition ultrasound imaging inside the artery (60MHz HD IVUS).

Main reasons for not taking part

  • Cardiogenic shock
  • ST-segment elevation heart attack
  • Narrowing inside an old stent, or stent clot
  • Left ventricular ejection fraction of 30% or lower
  • Pregnant, breastfeeding, or planning pregnancy within 1 year

The registry criteria, word for word

Show all 13 criteriaShow less

Who can take part

  • Documented myocardial ischaemia
  • At least one moderate to severely calcified native coronary artery lesion confirmed by QCA and/or 60MHz HD IVUS, with the presence of significant calcium, ≥70% diameter stenosis by visual estimation (in a reference vessel diameter of ≥2.5mm and ≤4.0mm) and TIMI 3 flow at baseline that is suitable for PCI; Significant calcium at the target lesion site is defined as either: i. The presence of radiopacities involving both sides of the arterial wall \>10mm and involving the target lesion on angiography; or ii. The presence of \>270° arc of superficial calcium on HD intravascular imaging with a length \>5mm or the presence of 360° arc of calcium on HD intravascular imaging. [1]
  • It is possible to cross the calcified lesion with a coronary guidewire
  • Age ≥ 18 years
  • Patient is willing and able to comply with the study procedures and follow-up

Who cannot take part

  • Documented allergy to everolimus or to any stent material 10. Any contraindication for dual antiplatelet therapy with aspirin and a P2Y12 inhibitor for at least 3 months (except for patients on oral anticoagulation). 11. For female, pregnancy, breastfeeding or intend to become pregnant within 1 year 12. Life expectancy \<1 year. 13. Participation in another study with an investigational product. 14. Inability to provide informed consent
  • ST-segment elevation myocardial infarction
  • Stent thrombosis
  • Left ventricular ejection fraction ≤30%. Need for coronary artery bypass graft surgery
  • Patients with cardiogenic shock
  • Instent re-stenosis
  • Coronary artery dissection
  • Chronic total occlusion in a major artery

Where in Ireland

  • Mater Private HospitalDublin, IrelandContact: Colm HanrattyTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The group in the trial

  • Patient treatment will follow a standardised algorithm for calcium modification

    All patients will have coronary angiography (QCA) and intravascular ultrasound (IVUS) imaging with 60MHz HD IVUS of the calcified lesion at baseline. The lesion will be characterized based on calcium distribution and morphology as assessed by HD IVUS. Depending on the specific lesion characteristics, the appropriate method for calcium modification will be chosen and performed in line with the CYCLOPES calcium modification algorithm included in the study protocol. The calcific lesion will be imaged for a second time by 60MHz HD IVUS following calcium modification. The operator will then proceed, if no further lesion preparation is required, to deploy a bioabsorbable polymer Everolimus eluting stent using standard stenting techniques, post dilatation will be performed at the operator's discretion. The treated lesion will be assessed again using intravascular ultrasound following stent deployment and optimization.

    Treatment: Calcium modification

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Implementation of a Standardized Algorithm for CoronarY CaLcificatiOn With PlaquE Modification Using UltraSound Guidance to Improve Procedural and Clinical Outcomes (CYCLOPES)
Plain-language title
Standard Steps for Treating Calcium Build-up in Heart ArteriesGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Publications
Record updated
7 November 2024