Prior Myocardial InfarctionPRIMENCT06811194
PRIor Myocardial Infarction Identification on Electrocardiogram
An observational study of Prior Myocardial Infarction, run by The Third People's Hospital of Chengdu at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 35 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Prior Myocardial Infarction
- How many people
- 12,000 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2025to 20 Feb 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prospective Cohort Study of Prior Myocardial Infarction Identification on Electrocardiogram: the PRIME Cohort Study
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.
Read the 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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiovascular death or nonfatal MI.
Primary outcome: cardiovascular death or nonfatal MI occurred during the 60-month follow-up after enrollment.
Measured: 60 Months after Enrollment
Secondary outcomes (1)
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.
Measured: 60 Months after Enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2025
- Study start20 Feb 2025 (estimated)
- Primary completion20 Feb 2026 (estimated)
- Study completion20 Feb 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prior Myocardial InfarctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 12,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Third People's Hospital of Chengdu
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hanxiong Liu, The Third People's Hospital of Chengdu
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06811194
- Sponsor's protocol ID
- Third Hospital Chengdu
- Acronym
- PRIME
- Status last verified
- Feb 2025
- First submitted
- 22 Jan 2025
- Last updated
- 6 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Cohort Study of Prior Myocardial Infarction Identification on Electrocardiogram: the PRIME Cohort Study
- ClinicalTrials.gov ID
- NCT06811194
- Acronym / sponsor ID
- PRIME / Third Hospital Chengdu
- Conditions
- Prior Myocardial Infarction
- Study type
- Observational
- Recruitment status
- Enrolling by invitation
- Enrolment
- 12,000 participants (estimated)
- Lead sponsor
- The Third People's Hospital of ChengduUniversity, hospital or other
- Study start
- 20 Feb 2025 (estimated)
- Primary completion
- 20 Feb 2026 (estimated)
- Study completion
- 20 Feb 2031 (estimated)
- First posted
- 6 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 35 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (7 listed)
- Aged between 35 and 85 years.
- Patients must meet at least one of the following conditions:
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Cardiovascular death or nonfatal MI.
Time frame: 60 Months after Enrollment
Primary outcome: cardiovascular death or nonfatal MI occurred during the 60-month follow-up after enrollment.
1 secondary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prior Myocardial Infarction, run by The Third People's Hospital of Chengdu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 6 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiovascular death or nonfatal MI. (time frame: 60 Months after Enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2025.