Clinical trial NCT01257282: Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)
Official title: Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Stable Angina Pectoris
Lead sponsor: Uppsala University
Sponsor class: OTHER
First posted: 2010-12-09
Enrollment: 275
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with stable coronary artery disease without previously known myocardial infarction or coronary intervention

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina.
timeFrame: 24 months
Secondary outcomes:
measure: Presence of unrecognized myocardial infarction
timeFrame: Baseline
measure: Size and localisation of unrecognized myocardial infarction
timeFrame: Baseline
measure: Degree and localization of artherosclerotic lesions at a coronary angiogram
timeFrame: Baseline
measure: Procedure related acute myocardial infarction
timeFrame: 5 years
measure: Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data
timeFrame: Baseline
measure: Long-term mortality, cardiac mortality and incidence of acute myocardial infarction
timeFrame: 5 years
Other outcomes:
Locations:
city: Falun
country: Sweden
facility: Falu Hospital
city: Gävle
country: Sweden
facility: Gävle Hospital
city: Linköping
country: Sweden
facility: Linköping University Hospital
city: Stockholm
country: Sweden
facility: Danderyds Hospital
city: Uppsala
country: Sweden
facility: Uppsala University Hospital
city: Örebro
country: Sweden
facility: Örebro University Hospital
Study officials:
affiliation: Uppsala University
name: Bertil Lindahl, professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: Nordenskjold AM, Hammar P, Ahlstrom H, Bjerner T, Duvernoy O, Eggers KM, Frobert O, Hadziosmanovic N, Lindahl B. Unrecognized Myocardial Infarction Assessed by Cardiac Magnetic Resonance Imaging--Prognostic Implications. PLoS One. 2016 Feb 17;11(2):e0148803. doi: 10.1371/journal.pone.0148803. eCollection 2016.
citation: Nordenskjold AM, Hammar P, Ahlstrom H, Bjerner T, Duvernoy O, Eggers KM, Frobert O, Hadziosmanovic N, Lindahl B. Unrecognized myocardial infarctions detected by cardiac magnetic resonance imaging are associated with cardiac troponin I levels. Clin Chim Acta. 2016 Apr 1;455:189-94. doi: 10.1016/j.cca.2016.01.029. Epub 2016 Jan 29.
citation: Hammar P, Nordenskjold AM, Lindahl B, Duvernoy O, Ahlstrom H, Johansson L, Hadziosmanovic N, Bjerner T. Unrecognized myocardial infarctions assessed by cardiovascular magnetic resonance are associated with the severity of the stenosis in the supplying coronary artery. J Cardiovasc Magn Reson. 2015 Nov 19;17:98. doi: 10.1186/s12968-015-0202-5.