PRIor Myocardial Infarction Identification on Electrocardiogram

NCT ID: NCT06811194

Last Updated: 2025-02-06

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Total Enrollment: 12000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-02-20
• Study Completion Date: 2031-02-20

Brief 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.

Detailed Description

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.

Conditions

Prior Myocardial Infarction

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Multicenter Cohort Study of Prior Myocardial Infarction

Myocardial infarction is a disease that affects the heart muscle, leading to a reduction in its function. When a patient has experienced a myocardial infarction in the past but no longer exhibits acute symptoms, it is referred to as an old myocardial infarction. This condition is typically characterized by the scarring of heart muscle tissue, resulting in partial loss of cardiac function. Patients may develop complications such as heart failure and arrhythmias. Although the symptoms may be mild, regular monitoring of cardiac function and status is essential. Early detection and management can effectively prevent further cardiovascular events. Therefore, regular medical check-ups and adherence to medical advice are crucial. For patients with a history of myocardial infarction, lifestyle modifications and pharmacological therapy are also important components in the recovery and maintenance of cardiac health.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Aged between 35 and 85 years.
• Patients must meet at least one of the following conditions:

• Diagnosis of prior MI based on ECG (as per the fourth universal definition of MI).
• History of prior MI (≥3 months post-MI).
• Any clinical suspicion of coronary artery disease (CAD) with at least two of the following risk factors:

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

• Life expectancy <1 year due to non-cardiovascular diseases.
• Contraindications to cardiac MRI or inability to complete the examination.
• History of non-ischemic cardiomyopathy.
• History of heart transplantation.
• Acute MI within the past 30 days.
• During pregnancy.

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 85 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

The Third People's Hospital of Chengdu

OTHER

Sponsor Role: lead

Responsible Party

Hanxiong Liu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

The Third People's Hospital of Chengdu

Chengdu, Sichuan, China

Countries

China

Other Identifiers

Third Hospital Chengdu

Identifier Type: -

Identifier Source: org_study_id