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Not yet recruiting NCT06565793

A MAajor RAdiation-based PCI Study in STEMI and NSTEMI

— Observational Myocardial Infarction (MI) Radiation Toxicity Coronary Stenosis Coronary Thrombosis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Non Complex PCI, Complex PCI.
Who it may be relevant to
Registry conditions: Myocardial Infarction (MI), Radiation Toxicity, Coronary Stenosis, Coronary Thrombosis. Basic parameters: 18 years — 90 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.

Overview

In France and Italy, approximately 240,000 percutaneous coronary angioplasties (PCI) are performed annually, with an increasing number of complex procedures, including those involving the left coronary common trunk, a bifurcation, chronic occlusion, or requiring Rotablator Rotary Atherectomy (ARota). The medical literature lacks sufficient data regarding several key aspects of complex angioplasty. These include the epidemiological characteristics of patients undergoing such procedures, the impact of irradiation delivered and the quantity of iodine injected on these lengthy procedures, their procedural complication rate, and in-hospital mortality.

Detailed description

A retrospective database of the hemodynamics department of the Centre Cardiologique du Nord and Clinica Mediterranea, comprising 15,630 consecutive angioplasties performed in unselected patients between February 1, 2008, and July 7, 2018, was used to identify complex angioplasties and standard angioplasties. Two categories of complex angioplasty were identified: complex angioplasty with a single complexity criterion and very complex angioplasty with two or more complexity criteria. These complex angioplasties were then compared with standard angioplasty (angioplasty with no complexity criteria).

The following criteria were employed to delineate complex or very complex angioplasties:

* Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI) * Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI) * Angioplasty of Chronic Coronary Occlusion (CCO-PCI) * Angioplasty of a Bifurcation Lesion (CBL-PCI)

The following definitions pertain to the classification of angioplasty procedures:

* Standard angioplasty: This encompasses angioplasty procedures that do not meet the criteria for complexity. * Complex angioplasty: This designation is applied to angioplasty procedures that meet at least one criterion for complexity. * Very complex angioplasty: This designation is applied to angioplasty procedures that meet at least two criteria for complexity.

Interventions

  • Device Non Complex PCI
    The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).
  • Device Complex PCI
    The patient cohort included individuals who had been hospitalized with a diagnosis of either STEMI or non-STEMI. The procedure involved complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).This designation is applied to angioplasty procedures that meet at least one criterion for complexity. The complex angioplasty involved patients with unprotected left coronary common trunk (UT-PCI), the use of rotablator rotary atherectomy (ARota-PCI), the angioplasty of c

Primary outcome measures

  • Death [Time frame: 30 days]
  • Death [Time frame: 1 year]
  • Death [Time frame: 5 years]
  • Myocardial Infarction [Time frame: 30 days]
  • Myocardial Infarction [Time frame: 1 year]
  • Myocardial Infarction [Time frame: 5 years]
  • Stent Thrombosis [Time frame: 30 days]
  • Stent Thrombosis [Time frame: 1 year]
  • Stent Thrombosis [Time frame: 5 years]
  • Acute Kidney Injury [Time frame: 30 days]
Secondary outcome measures (4)
  • Target Vessel Revascularization [Time frame: 1 year]
  • Target Vessel Revascularization [Time frame: 5 years]
  • Target Lesion Revascularization [Time frame: 1 year]
  • Target Lesion Revascularization [Time frame: 5 years]

Eligibility criteria

Inclusion criteria

  • The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.

Exclusion criteria

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Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06565793 · ID: CN-08-24

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗