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

Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01257282
Acronym
PUMI
Enrollment
275
Registered
2010-12-09
Start date
2007-09-30
Completion date
2013-03-31
Last updated
2010-12-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stable Angina Pectoris

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).

Interventions

None listed

Sponsors

Uppsala University
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Presence of unrecognized myocardial infarctionBaseline
Size and localisation of unrecognized myocardial infarctionBaseline
Degree and localization of artherosclerotic lesions at a coronary angiogramBaseline
Procedure related acute myocardial infarction5 years
Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric dataBaseline
Long-term mortality, cardiac mortality and incidence of acute myocardial infarction5 years

Countries

Sweden

Contacts

Primary ContactBertil Lindahl, professor
bertil.lindahl@ucr.uu.se+46 18 611 95 05

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 15, 2026