Last reviewed · How we verify

NCT06811194: PRIME

PRIor Myocardial Infarction Identification on Electrocardiogram

ENROLLING BY INVITATION Last updated 6 February 2025
What this trial tests

trial in Prior Myocardial Infarction in 12,000 participants. Enrolling by invitation.

Timeline
20 February 2025
Primary endpoint
20 February 2026
20 February 2031

Quick facts

Lead sponsorThe Third People's Hospital of Chengdu
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment12,000
Start date20 February 2025
Primary completion20 February 2026
Estimated completion20 February 2031
Sites1 location across China

Conditions studied

Sponsor

The Third People's Hospital of Chengdu

Who can join

Adults 35 to 85, any sex, with Prior Myocardial Infarction. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own 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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

Verify or expand the search:

Other The Third People's Hospital of Chengdu trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06811194.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing