A MAajor RAdiation-based PCI Study in STEMI and NSTEMI
MARAA
The Impact of Radiation Delivered to the Patient and the Amount of Iodinated Contrast Medium Injected in Complex Versus Noncomplex Percutaneous Coronary Intervention.
1 other identifier
observational
15,630
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Mar 2025
Shorter than P25 for all trials
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 11, 2024
CompletedFirst Posted
Study publicly available on registry
August 22, 2024
CompletedStudy Start
First participant enrolled
March 1, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2025
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2025
CompletedDecember 27, 2024
December 1, 2024
4 months
August 11, 2024
December 21, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (19)
Death
The primary end point of the study is the rate of death
30 days
Death
The primary end point of the study is the rate of death
1 year
Death
The primary end point of the study is the rate of death
5 years
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
30 days
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
1 year
Myocardial Infarction
The primary end point of the study is the rate of myocardial infarction
5 years
Stent Thrombosis
The primary end point of the study is the rate of stent thrombosis
30 days
Stent Thrombosis
The primary end point of the study is the rate of stent thrombosis
1 year
Stent Thrombosis
The primary end point of the study is the rate of stent thrombosis
5 years
Acute Kidney Injury
The primary end point of the study is the rate of acute kidney injury
30 days
Acute Kidney Injury
The primary end point of the study is the rate of acute kidney injury
1 years
Coronary Obstruction Requiring Intervention
The primary end point of the study is the rate of coronary obstruction requiring intervention
30 days
Coronary Obstruction Requiring Intervention
The primary end point of the study is the rate of coronary obstruction requiring intervention
1 year
Coronary Obstruction Requiring Intervention
The primary end point of the study is the rate of coronary obstruction requiring intervention
5 years
Increase in Tnl and Tnt Levels
The primary end point of the study is the rate in increase of Tnl and Tnt levels
30 days
Increase in Tnl and Tnt Levels
The primary end point of the study is the rate in increase of Tnl and Tnt levels
1 year
Rehospitalization
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
30 days
Rehospitalization
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
1 year
Rehospitalization
The primary end point of the study is the rate of rehospitalization (coronary-related or procedure-related, including heart failure)
5 years
Secondary Outcomes (4)
Target Vessel Revascularization
1 year
Target Vessel Revascularization
5 years
Target Lesion Revascularization
1 year
Target Lesion Revascularization
5 years
Study Arms (2)
Non Complex PCI
The objective of this study is to examine the efficacy of percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES) in patients diagnosed with ST-Elevation Myocardial Infarction (STEMI) or Non-ST-Elevation Myocardial Infarction (NSTEMI).
Complex PCI
This study focuses on patients diagnosed with either STEMI or NSTEMI who have undergone complex percutaneous coronary intervention (PCI) with the use of drug-eluting stents (DES).The following criteria were used to distinguish between complex and very complex angioplasty cases: The following procedures have been identified as complex or very complex: * Unprotected Left Coronary Common Trunk Angioplasty (UT-PCI) * Angioplasty with Rotablator Rotary Atherectomy (ARota-PCI) * Angioplasty of Chronic Coronary Occlusion (CCO-PCI)
Interventions
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).
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 chronic coronary occlusion (CCO-PCI), or the angioplasty of a bifurcation lesion (CBL-PCI).The highly intricate angioplasty procedure was conducted on patients who met at least two criteria indicative of complexity.
Eligibility Criteria
* 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.
You may qualify if:
- The patient presents with a STEMI or NSTEMI requiring either a non-complex or complex PCI.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Cardiologique du Nordlead
- Clinica Mediterraneacollaborator
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Francesco Nappi, MD
Centre Cardiologique du Nord
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 5 Years
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Consultan
Study Record Dates
First Submitted
August 11, 2024
First Posted
August 22, 2024
Study Start
March 1, 2025
Primary Completion
July 1, 2025
Study Completion
December 31, 2025
Last Updated
December 27, 2024
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will not share