Clinical Features and Linked MEchanisms in Acute Risk-free AMI (CLEAR-AMI)

Capital Medical University

Status: Not yet enrolling

Conditions: Actue Coronary Syndrome

Study type: Observational

Funder types: Other

Identifiers

NCT06716177

KS2024119

Details and patient eligibility

About

This study aims to investigate the clinical characteristics and underlying mechanisms of acute myocardial infarction (AMI) in patients without traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, or smoking history. By analyzing clinical data, imaging findings, and biomarkers, the research seeks to identify novel risk factors and mechanisms contributing to the pathogenesis of AMI in this unique population. The findings are expected to provide insights into improving diagnostic strategies and developing

Full description

Acute myocardial infarction (AMI) is a leading cause of morbidity and mortality worldwide, primarily associated with well-established cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, and obesity. However, a subset of AMI patients present without these traditional risk factors, posing a diagnostic and therapeutic challenge. This study focuses on the clinical characteristics, pathophysiological mechanisms, and potential novel risk factors associated with AMI in patients who lack conventional cardiovascular risk profiles.

The study will be conducted as a single-center observational analysis involving patients diagnosed with AMI but without a history of hypertension, diabetes, dyslipidemia, smoking, or significant family history of coronary artery disease. Key objectives include:

Characterizing Clinical Features: Analyzing demographic, clinical, and imaging data to identify patterns unique to this patient population.

Identifying Biomarkers: Exploring circulating biomarkers, including inflammatory markers, genetic predispositions, and coagulation abnormalities, that may contribute to AMI development.

Understanding Mechanisms: Investigating potential mechanisms such as microvascular dysfunction, endothelial injury, and autoimmune or hypercoagulable states.

The study will utilize advanced imaging techniques, including coronary computed tomography angiography (CTA) and cardiac magnetic resonance imaging (CMR), to assess coronary anatomy and myocardial tissue characteristics. Genomic and proteomic analyses will be performed to identify genetic and molecular contributors.

By elucidating the clinical and mechanistic profile of AMI in this unique population, the research aims to enhance the understanding of nontraditional pathways leading to AMI. These findings will pave the way for improved diagnostic tools, risk stratification models, and novel therapeutic interventions tailored to this underexplored patient group.

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

Patients diagnosed with acute myocardial infarction (AMI) based on standard clinical criteria (e.g., troponin elevation, ischemic symptoms, or imaging evidence of myocardial injury).

Absence of traditional cardiovascular risk factors, including hypertension, diabetes, dyslipidemia, smoking, or obesity (BMI < 30 kg/m²).

Aged 18 years or older. Willing and able to provide informed consent.

Exclusion criteria

Presence of any traditional cardiovascular risk factors as defined above. History of known congenital or structural heart disease. Severe systemic diseases that could independently contribute to AMI (e.g., severe infection, malignancy, or autoimmune disorders).

Recent history of major surgery or trauma within the last 3 months. Pregnancy or lactation. Inability to provide informed consent due to cognitive impairment or other reasons.

Participation in another interventional clinical trial that might interfere with study outcomes.

Trial design

300 participants in 1 patient group

Patients Without Traditional Cardiovascular Risk Factors Experiencing AMI

Description:

This cohort includes patients diagnosed with acute myocardial infarction (AMI) who do not exhibit traditional cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, or obesity. Participants will undergo comprehensive clinical assessments, including advanced imaging (coronary computed tomography angiography and cardiac magnetic resonance imaging), biomarker profiling, and genetic analyses. No direct therapeutic interventions will be applied as part of this study; instead, observational methods will be used to analyze clinical characteristics, identify novel biomarkers, and explore mechanisms contributing to AMI pathogenesis in this population. Data collected from this cohort will provide insights into the unique features and risk profiles of AMI patients without conventional risk factors, potentially informing future diagnostic and therapeutic strategies.