The Third People's Hospital of Chengdu
Chengdu, Sichuan, China
NCT Number: NCT06811194
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.
Interested in participating?
Request Info35 year–85 year
All sexes
Observational
Chengdu, Sichuan, China
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Male age >50 years or female age >60 years. Diabetes mellitus. Hypertension. Hypercholesterolemia requiring medication. Family history of premature CAD (first-degree relatives: male ≤55 years, female ≤65 years).
Body mass index (BMI) ≥30 kg/m². History of peripheral vascular disease. History of coronary artery intervention or bypass surgery. Informed consent obtained
Exclusion criteria
Time frame: 60 Months after Enrollment
Primary outcome: cardiovascular death or nonfatal MI occurred during the 60-month follow-up after enrollment.
Time frame: 60 Months after Enrollment
Secondary outcome was defined by a composite of cardiovascular death, nonfatal MI, hospitalization for unstable angina or congestive heart failure, and late unplanned CABG.
The Third People's Hospital of Chengdu
Other
Prospective Cohort Study of Prior Myocardial Infarction Identification on Electrocardiogram: the PRIME Cohort Study
Acronym: PRIME
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