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Clinical Trials/NCT06948240
NCT06948240CompletedNot Applicable

Atrial Fibrillation Long Term Outcomes

Fundacion Miguel Servet1 site in 1 country400 target enrollmentStarted: April 1, 2024Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
400
Locations
1
Primary Endpoint
Composite long-term outcome

Study Overview

Brief Summary

Introduction Coronary embolism (CE) is a relatively rare but significant cause of non-atherosclerotic acute myocardial infarction (AMI), representing about 3% of all AMI cases, though it is likely underdiagnosed. CE is associated with worse clinical outcomes than traditional atherosclerotic AMI, showing increased rates of cardiac death and cerebrovascular events. Atrial fibrillation (AF) is the primary underlying cause of CE, cited in 28%-73% of cases across large series. Despite AF's central role, comprehensive data detailing the clinical, biochemical, echocardiographic, angiographic characteristics, and outcomes of CE specifically linked to AF remains limited. This study aims to address this knowledge gap by retrospectively evaluating patients with AF-related CE (AF CE) and non-AF CE, characterizing their differences and identifying outcome predictors.

Methods From January 2008 to Dicember 2024, consecutive patients admitted to a tertiary care cardiology unit and meeting both the Fourth Universal Definition of AMI and either definite or probable CE per Shibata's criteria were retrospectively included. Shibata's classification involves major and minor angiographic and clinical criteria to establish the likelihood of CE. Definite CE is diagnosed with a combination of major and minor criteria, while probable CE requires fewer criteria. Cases with evidence of atherosclerotic thrombus, prior revascularization, coronary anomalies like ectasia, spontaneous coronary artery dissection, or stress cardiomyopathy were excluded.

Coronary Embolism Definition

The Shibata criteria define CE based on:

Major criteria: angiographic embolism signs unrelated to atherosclerosis, multisite CE, systemic embolism excluding left ventricular thrombus from STEMI.

Minor criteria: non-significant coronary stenosis (<25%), embolic source identified by imaging, and risk factors like AF, dilated cardiomyopathy, rheumatic valve disease, prosthetic valves, recent cardiac surgery, coagulation disorders, patent foramen ovale, or atrial septal defect.

Coronary Arteriography All patients underwent invasive coronary angiography, independently reviewed by two specialists. Stenoses were visually assessed according to recognized grading systems.

Echocardiography Transthoracic echocardiography was performed following contemporary guidelines, evaluating left atrial and ventricular size and function, and left atrial strain using speckle tracking with standardized software (Philips).

Cardiac Magnetic Resonance (CMR) CMR was performed in patients initially diagnosed with MINOCA (Myocardial Infarction with Non-Obstructive Coronary Arteries) based on standard protocols, evaluating for subendocardial or transmural late gadolinium enhancement and focal myocardial edema to support CE diagnosis.

Atrial Fibrillation Definition AF was diagnosed as per ESC guidelines, requiring over 30 seconds of rhythm without P waves and irregular RR intervals. Both history of AF and new-onset AF during hospitalization or follow-up qualified for classification into the AF CE group.

Outcomes

Two types of outcomes were evaluated:

In-hospital outcomes: composite of heart failure, cardiogenic shock, ventricular arrhythmias, stroke, or death.

Long-term outcomes: composite of reinfarction, systemic embolism, stroke, cardiac or all-cause mortality.

Ethics The study protocol was approved by an independent ethics committee, with a waiver of informed consent, justified under the principles of the Declaration of Helsinki (reference n° 3318-0000257).

Statistical Analysis Categorical variables were presented as frequencies and percentages, continuous variables as means ± standard deviations. AF CE and non-AF CE groups were compared using Chi-square or Fisher's exact tests for qualitative variables, and parametric or non-parametric tests for quantitative variables depending on distribution normality (Kolmogorov-Smirnov test). For in-hospital outcomes, univariable logistic regression was performed to identify associated variables, followed by multivariable stepwise forward logistic regression for variables with p < 0.1. Long-term outcomes were assessed using univariable Cox regression and multivariable stepwise forward Cox regression for significant variables. Kaplan-Meier survival analyses and log-rank tests evaluated long-term outcome differences. SPSS version 20 (IBM) was used, with p < 0.05 considered statistically significant.

Detailed Description

INTRODUCTION

Coronary embolism (CE) represents a distinct and under-recognized cause of acute myocardial infarction (AMI) that does not involve atherosclerotic processes. Despite its relatively low reported prevalence of around 3%, CE remains clinically significant due to its association with adverse cardiovascular outcomes, including a higher incidence of cardiac-related mortality and cerebrovascular accidents. A wide spectrum of conditions can precipitate CE events. Among these, atrial fibrillation (AF) stands out as the most frequently implicated, followed by other contributors such as infective endocarditis, dilated cardiomyopathy, intracardiac tumors, coagulation abnormalities, and anatomical defects like patent foramen ovale.

Two major retrospective series in the field have indicated that AF accounts for a substantial proportion of CE cases, ranging from approximately 28% to 73%. Yet, despite this established link, the specific clinical, imaging, and prognostic profiles of AF-related CE remain inadequately described. Traditional understanding has primarily focused on atherosclerotic AMI, while data delineating the behavior and outcomes of embolic events of cardiac origin, especially in the setting of AF, are sparse.

In this context, the study was undertaken to systematically characterize and compare CE associated with AF (AF CE) and CE from other causes (non-AF CE). The investigators aimed to comprehensively document demographic features, risk factor profiles, laboratory results, echocardiographic parameters, angiographic findings, and subsequent clinical outcomes for both groups. Through this approach, they intended not only to fill existing knowledge gaps but also to identify prognostic indicators that could influence management and improve outcomes in this challenging clinical scenario.

MATERIALS AND METHODS

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Retrospective

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •Consecutive patients admitted to a specialized cardiology care facility were retrospectively reviewed for inclusion in the study. Eligibility was contingent upon two primary criteria: fulfillment of the Fourth Universal Definition of AMI and classification as definite or probable CE according to the diagnostic framework proposed by Shibata et al. Patients satisfying these combined diagnostic benchmarks were incorporated into the final study cohort.

Exclusion Criteria

  • •Patients exhibiting angiographic or intracoronary imaging evidence of atherosclerotic thrombus, previous percutaneous coronary intervention or bypass grafting, coronary artery ectasia, plaque rupture or erosion, spontaneous coronary artery dissection, or coronary vasospasm were excluded. Likewise, patients with stress-induced cardiomyopathy were also excluded

Outcomes

Primary Outcomes

Composite long-term outcome

Time Frame: Since January 2008 to Dicember 2024

Composite of stroke, reinfarction, heart failure, cardiovascular death, all-cause death

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Fundacion Miguel Servet
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Alberto Vera Sainz

MD PHD Cardiology

Fundacion Miguel Servet

Study Sites (1)

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