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ENROLLING BY INVITATION
NCT06811194

PRIor Myocardial Infarction Identification on Electrocardiogram

Sponsor: The Third People's Hospital of Chengdu

View on ClinicalTrials.gov

Summary

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.

Official title: Prospective Cohort Study of Prior Myocardial Infarction Identification on Electrocardiogram: the PRIME Cohort Study

Key Details

Gender

All

Age Range

35 Years - 85 Years

Study Type

OBSERVATIONAL

Enrollment

12000

Start Date

2025-02-20

Completion Date

2031-02-20

Last Updated

2025-02-06

Healthy Volunteers

Yes

Locations (1)

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China