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

November 29, 2024 updated by: Jiayi Yi, Beijing Anzhen Hospital

Clinical Features and Mechanisms of Acute Myocardial Infarction in Patients Without Traditional Cardiovascular Risk Factors

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

Study Overview

Status

Not yet recruiting

Conditions

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.

Study Type

Observational

Enrollment (Estimated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients Without Traditional Cardiovascular Risk Factors Experiencing AMI

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of Acute Myocardial Infarction (AMI) Without Traditional Cardiovascular Risk Factors
Time Frame: 5 years
The primary outcome measure is the identification and characterization of acute myocardial infarction (AMI) cases occurring in patients who lack traditional cardiovascular risk factors, such as hypertension, diabetes, dyslipidemia, smoking, or obesity. The outcome will be evaluated by analyzing clinical presentation, laboratory biomarkers, imaging findings, and other diagnostic criteria to confirm the occurrence of AMI and its distinct features in this unique patient population. This will be assessed at the time of diagnosis and through follow-up evaluations during the study period.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Beijing Anzhen Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

January 1, 2025

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

January 1, 2030

Study Registration Dates

First Submitted

November 29, 2024

First Submitted That Met QC Criteria

November 29, 2024

First Posted (Estimated)

December 4, 2024

Study Record Updates

Last Update Posted (Estimated)

December 4, 2024

Last Update Submitted That Met QC Criteria

November 29, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KS2024119

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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