Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)

• Conditions: Stable Angina Pectoris

• Registration Number: NCT01257282
• Lead Sponsor: Uppsala University

Brief Summary

This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognized myocardial damage and its prognostic implication.

Detailed Description

A substantial portion of all myocardial infarctions are not clinically recognized, but the myocardial damage can be recognized afterwards e g by magnetic resonance imaging (MRI). This study includes patients with stable coronary artery disease without previously known myocardial infarction, and investigates the prevalence of clinically unrecognised myocardial damage (UMI), and the prognostic value of UMI regarding new cardiac events.

In a subset of the patients, the biologic intra-individual variability of troponin and other biochemical markers will be investigated (substudy protocol).

Study Timeline

• Study Start: 2007-09
• Status Verified: 2010-12
• Study First Submitted: 2010-12-06
• Study First Submitted QC: 2010-12-08
• Last Update Submitted: 2010-12-08
• Study First Posted: 2010-12-09
• Last Update Posted: 2010-12-09
• Primary Completion: 2013-03
• Study Completion: 2013-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 275

Inclusion Criteria

• symptoms of stable angina pectoris according to the treating physician
• scheduled for coronary angiography
• written informed consent

Exclusion Criteria

• pathological Q-wave in the 12-lead resting ECG
• known previous myocardial infarction
• previous PCI (percutaneous coronary intervention) or CABG (coronary artery bypass graft)
• history of congestive heart failure
• anything that contraindicates a MRI investigation (e.g. pacemaker, claustrophobia, intracranial clips)
• lack of suitability for participation in the trial, for any reason, as judged by the Investigator.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina.	24 months

Secondary Outcome Measures

Name	Time	Method
Presence of unrecognized myocardial infarction	Baseline
Size and localisation of unrecognized myocardial infarction	Baseline
Procedure related acute myocardial infarction	5 years
Degree and localization of artherosclerotic lesions at a coronary angiogram	Baseline
Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data	Baseline
Long-term mortality, cardiac mortality and incidence of acute myocardial infarction	5 years

Trial Locations

Locations (6)

Falu Hospital; 🇸🇪 Falun, Sweden

Gävle Hospital; 🇸🇪 Gävle, Sweden

Uppsala University Hospital; 🇸🇪 Uppsala, Sweden

Danderyds Hospital; 🇸🇪 Stockholm, Sweden

Linköping University Hospital; 🇸🇪 Linköping, Sweden

Örebro University Hospital; 🇸🇪 Örebro, Sweden