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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified December 2010 by Uppsala University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01257282
First received: December 6, 2010
Last updated: December 8, 2010
Last verified: December 2010

December 6, 2010
December 8, 2010
September 2007
March 2013   (final data collection date for primary outcome 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. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01257282 on ClinicalTrials.gov Archive Site
  • Presence of unrecognized myocardial infarction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Size and localisation of unrecognized myocardial infarction [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Degree and localization of artherosclerotic lesions at a coronary angiogram [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Procedure related acute myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
  • Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data [ Time Frame: Baseline ] [ Designated as safety issue: No ]
  • Long-term mortality, cardiac mortality and incidence of acute myocardial infarction [ Time Frame: 5 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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).

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Plasma samples for biochemical markers. Whole blood samples for extraction of DNA for genetic analysis.

Non-Probability Sample

Patients with stable coronary artery disease without previously known myocardial infarction or coronary intervention

Stable Angina Pectoris
Not Provided
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
275
March 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
Not Provided
No
Contact: Bertil Lindahl, professor +46 18 611 95 05 bertil.lindahl@ucr.uu.se
Sweden
 
NCT01257282
U-07-001
No
professor Bertil Lindahl, Uppsala Clinical Research Centre
Uppsala University
Not Provided
Principal Investigator: Bertil Lindahl, professor Uppsala University
Uppsala University
December 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP