Abstract Background: Chronic myocardial infarction (MI) is a serious cardiovascular disease associated with high mortality rates, making early diagnosis and timely intervention essential for improving patient outcomes. However, some patients may present without clear symptoms or relevant medical histories, complicating the diagnostic process. Currently, diagnosis predominantly relies on electrocardiograms (ECGs) and imaging tests. Although cardiac magnetic resonance imaging (MRI) is regarded as the gold standard, its high cost and complexity hinder its clinical application. Consequently, there is an urgent need for new ECG diagnostic criteria to mitigate the risks of misdiagnosis and missed diagnoses. Objective: This study aims to explore new diagnostic criteria to enhance the accuracy of ECG diagnoses for chronic MI. Methods: This research is a prospective, multicenter cohort study designed to assess the impact of newly developed ECG diagnostic criteria on the accuracy of chronic myocardial infarction (MI) diagnoses. The study spans a 60-month period, including a 12-month patient enrollment phase. Participants will comprise individuals aged 35 to 85 who meet the inclusion criteria: those diagnosed with chronic myocardial infarction via ECG, those with a definitive history of MI (≥3 months), or individuals clinically suspected of having coronary artery disease with at least two coronary risk factors. Data collection will include clinical symptoms, signs, ECG findings, and cardiac magnetic resonance (CMR) findings, the latter serving as a primary endpoint. Follow-up will focus on changes in patients' symptoms and ECG assessments. Statistical analysis software will be employed to evaluate the influence of the new diagnostic criteria on rates of missed and misdiagnosis.
Abstract Background: Chronic myocardial infarction (MI) is a serious cardiovascular disease associated with high mortality rates, making early diagnosis and timely intervention essential for improving patient outcomes. However, some patients may present without clear symptoms or relevant medical histories, complicating the diagnostic process. Currently, diagnosis predominantly relies on electrocardiograms (ECGs) and imaging tests. Although cardiac magnetic resonance imaging (MRI) is regarded as the gold standard, its high cost and complexity hinder its clinical application. Consequently, there is an urgent need for new ECG diagnostic criteria to mitigate the risks of misdiagnosis and missed diagnoses. Objective: This study aims to explore new diagnostic criteria to enhance the accuracy of ECG diagnoses for chronic MI. Methods: This research is a prospective, multicenter cohort study designed to assess the impact of newly developed ECG diagnostic criteria on the accuracy of chronic myocardial infarction (MI) diagnoses. The study spans a 60-month period, including a 12-month patient enrollment phase. Participants will comprise individuals aged 35 to 85 who meet the inclusion criteria: those diagnosed with chronic myocardial infarction via ECG, those with a definitive history of MI (≥3 months), or individuals clinically suspected of having coronary artery disease with at least two coronary risk factors. Data collection will include clinical symptoms, signs, ECG findings, and cardiac magnetic resonance (CMR) findings, the latter serving as a primary endpoint. Follow-up will focus on changes in patients' symptoms and ECG assessments. Statistical analysis software will be employed to evaluate the influence of the new diagnostic criteria on rates of missed and misdiagnosis.
Study Type
OBSERVATIONAL
Enrollment
12,000
The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
Cardiovascular death or nonfatal MI.
Primary outcome: cardiovascular death or nonfatal MI occurred during the 60-month follow-up after enrollment.
Time frame: 60 Months after Enrollment
A composite of cardiovascular death, nonfatal MI, hospitalization for unstable angina or congestive heart failure, and late unplanned CABG.
Secondary outcome was defined by a composite of cardiovascular death, nonfatal MI, hospitalization for unstable angina or congestive heart failure, and late unplanned CABG.
Time frame: 60 Months after Enrollment
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