Clinical trial NCT06716177: Clinical Features and Linked MEchanisms in Acute Risk-free AMI
Official title: Clinical Features and Mechanisms of Acute Myocardial Infarction in Patients Without Traditional Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Actue Coronary Syndrome
Keywords: Acute Coronary Syndromes
Risk factor
Multi-omics analysis
Lead sponsor: Beijing Anzhen Hospital
Sponsor class: OTHER
First posted: 2024-12-04
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population includes patients diagnosed with acute myocardial infarction (AMI) who lack traditional cardiovascular risk factors such as hypertension, diabetes, dyslipidemia, smoking, and obesity. These patients are recruited from a single-center or multicenter setting, such as hospitals with advanced cardiac care facilities.

The population represents a unique subset of AMI patients, often underexplored in existing research. Comprehensive data, including demographic information, clinical presentations, imaging findings, laboratory biomarkers, and genetic profiles, will be collected to investigate novel risk factors and pathophysiological mechanisms contributing to AMI in this group. The study seeks to provide a detailed understanding of the characteristics and etiology of AMI in this nontraditional population.

Brief summary: 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

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Incidence of Acute Myocardial Infarction (AMI) Without Traditional Cardiovascular Risk Factors
timeFrame: 5 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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