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

Uppsala University275 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

275

Conditions

Stable Angina Pectoris

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (6)

Falu Hospital

Falun, Sweden

RECRUITING

Gävle Hospital

Gävle, Sweden

RECRUITING

Linköping University Hospital

Linköping, Sweden

Outcomes

Primary Outcomes

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

Time frame: 24 months

Secondary Outcomes

Presence of unrecognized myocardial infarction

Time frame: Baseline

Size and localisation of unrecognized myocardial infarction

Time frame: Baseline

Degree and localization of artherosclerotic lesions at a coronary angiogram

Time frame: Baseline

Procedure related acute myocardial infarction

Time frame: 5 years

Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data

Time frame: Baseline

Long-term mortality, cardiac mortality and incidence of acute myocardial infarction

Time frame: 5 years

Central Contacts

Bertil Lindahl, professor

CONTACT

+46 18 611 95 05 bertil.lindahl@ucr.uu.se

Data from ClinicalTrials.gov

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