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Not yet recruiting NCT06716177

Clinical Features and Linked mEchanisms in Acute Risk-free AMI

Observational Actue Coronary Syndrome

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Actue Coronary Syndrome. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Incidence of Acute Myocardial Infarction (AMI) Without Traditional Cardiovascular Risk Factors [Time frame: 5 years]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Center list to be confirmed — check the primary protocol.

Publications

  • Shamaki GR, Safiriyu I, Kesiena O, Mbachi C, Anyanwu M, Zahid S, Rai D, Bob-Manuel T, Corteville D, Alweis R, Batchelor WB. Prevalence and Outcomes in STEMI Patients Without Standard Modifiable Cardiovascular Risk Factors: A National Inpatient Sample Analysis. Curr Probl Cardiol. 2022 Nov;47(11):101343. doi: 10.1016/j.cpcardiol.2022.101343. Epub 2022 Aug 5. PMID 35934021
  • Vernon ST, Coffey S, D'Souza M, Chow CK, Kilian J, Hyun K, Shaw JA, Adams M, Roberts-Thomson P, Brieger D, Figtree GA. ST-Segment-Elevation Myocardial Infarction (STEMI) Patients Without Standard Modifiable Cardiovascular Risk Factors-How Common Are They, and What Are Their Outcomes? J Am Heart Assoc. 2019 Nov 5;8(21):e013296. doi: 10.1161/JAHA.119.013296. Epub 2019 Nov 1. PMID 31672080
  • Anderson JL, Knight S, May HT, Le VT, Almajed J, Bair TL, Knowlton KU, Muhlestein JB. Cardiovascular Outcomes of ST-Elevation Myocardial Infarction (STEMI) Patients without Standard Modifiable Risk Factors (SMuRF-Less): The Intermountain Healthcare Experience. J Clin Med. 2022 Dec 22;12(1):75. doi: 10.3390/jcm12010075. PMID 36614876
  • Chandrashekhar Y, Alexander T, Mullasari A, Kumbhani DJ, Alam S, Alexanderson E, Bachani D, Wilhelmus Badenhorst JC, Baliga R, Bax JJ, Bhatt DL, Bossone E, Botelho R, Chakraborthy RN, Chazal RA, Dhaliwal RS, Gamra H, Harikrishnan SP, Jeilan M, Kettles DI, Mehta S, Mohanan PP, Kurt Naber C, Naik N, Ntsekhe M, Otieno HA, Pais P, Pineiro DJ, Prabhakaran D, Reddy KS, Redha M, Roy A, Sharma M, Shor R, PMID 32539609
  • Roth GA, Mensah GA, Johnson CO, Addolorato G, Ammirati E, Baddour LM, Barengo NC, Beaton AZ, Benjamin EJ, Benziger CP, Bonny A, Brauer M, Brodmann M, Cahill TJ, Carapetis J, Catapano AL, Chugh SS, Cooper LT, Coresh J, Criqui M, DeCleene N, Eagle KA, Emmons-Bell S, Feigin VL, Fernandez-Sola J, Fowkes G, Gakidou E, Grundy SM, He FJ, Howard G, Hu F, Inker L, Karthikeyan G, Kassebaum N, Koroshetz W, L PMID 33309175

Identifiers

NCT: NCT06716177 · KS2024119

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗