Clinical trial NCT06565793: A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
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.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Myocardial Infarction (MI)
Radiation Toxicity
Coronary Stenosis
Coronary Thrombosis
Coronary Artery Calcification
Coronary Occlusion
Coronary Syndrome
Coronary Artery Disease
Keywords: PCI,DES, Radiation
Lead sponsor: Centre Cardiologique du Nord
Sponsor class: OTHER
Collaborators: name: Clinica Mediterranea
First posted: 2024-08-22
Enrollment: 15630
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * 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.

Brief summary: 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: Death
timeFrame: 30 days
measure: Death
timeFrame: 1 year
measure: Death
timeFrame: 5 years
measure: Myocardial Infarction
timeFrame: 30 days
measure: Myocardial Infarction
timeFrame: 1 year
measure: Myocardial Infarction
timeFrame: 5 years
measure: Stent Thrombosis
timeFrame: 30 days
measure: Stent Thrombosis
timeFrame: 1 year
measure: Stent Thrombosis
timeFrame: 5 years
measure: Acute Kidney Injury
timeFrame: 30 days
measure: Acute Kidney Injury
timeFrame: 1 years
measure: Coronary Obstruction Requiring Intervention
timeFrame: 30 days
measure: Coronary Obstruction Requiring Intervention
timeFrame: 1 year
measure: Coronary Obstruction Requiring Intervention
timeFrame: 5 years
measure: Increase in Tnl and Tnt Levels
timeFrame: 30 days
measure: Increase in Tnl and Tnt Levels
timeFrame: 1 year
measure: Rehospitalization
timeFrame: 30 days
measure: Rehospitalization
timeFrame: 1 year
measure: Rehospitalization
timeFrame: 5 years
Secondary outcomes:
measure: Target Vessel Revascularization
timeFrame: 1 year
measure: Target Vessel Revascularization
timeFrame: 5 years
measure: Target Lesion Revascularization
timeFrame: 1 year
measure: Target Lesion Revascularization
timeFrame: 5 years
Other outcomes:
Locations:
Study officials:
affiliation: Centre Cardiologique du Nord
name: Francesco Nappi, MD
role: PRINCIPAL_INVESTIGATOR
References: