Clinical trial NCT06811194: PRIor Myocardial Infarction Identification on Electrocardiogram
Official title: Prospective Cohort Study of Prior Myocardial Infarction Identification on Electrocardiogram: the PRIME Cohort Study
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Prior Myocardial Infarction
Lead sponsor: The Third People's Hospital of Chengdu
Sponsor class: OTHER
First posted: 2025-02-06
Enrollment: 12000
Sex: ALL
Minimum age (years): 35
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: An old MI is a condition in which the patient has experienced a myocardial infarction in the past, but no acute symptoms are present at this time. This condition usually manifests as scarring of the heart muscle tissue, resulting in a partial loss of heart muscle function. Patients may experience complications such as heart failure and arrhythmia, and although the symptoms may be mild, it is still necessary to regularly monitor the function and status of the heart. Early detection and management can effectively prevent further cardiovascular events, so regular medical check-ups and following medical advice are particularly important. For patients who have had an old heart attack, lifestyle adjustments and medication are also important components of restoring and maintaining heart health

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.

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.

Primary outcomes:
measure: Cardiovascular death or nonfatal MI.
timeFrame: 60 Months after Enrollment
Secondary outcomes:
measure: A composite of cardiovascular death, nonfatal MI, hospitalization for unstable angina or congestive heart failure, and late unplanned CABG.
timeFrame: 60 Months after Enrollment
Other outcomes:
Locations:
city: Chengdu
country: China
facility: The Third People's Hospital of Chengdu
state: Sichuan
Study officials:
References: