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

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ClinicalTrials.gov Identifier: NCT01257282
Recruitment Status : Unknown
Verified December 2010 by Uppsala University.
Recruitment status was:  Recruiting
First Posted : December 9, 2010
Last Update Posted : December 9, 2010
Sponsor:
Information provided by:

Study Description
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.

Condition or disease
Stable Angina Pectoris

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 Design

Study Type : Observational
Estimated Enrollment : 275 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.
Study Start Date : September 2007
Estimated Primary Completion Date : March 2013
Estimated Study Completion Date : March 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts


Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Presence of unrecognized myocardial infarction [ Time Frame: Baseline ]
  2. Size and localisation of unrecognized myocardial infarction [ Time Frame: Baseline ]
  3. Degree and localization of artherosclerotic lesions at a coronary angiogram [ Time Frame: Baseline ]
  4. Procedure related acute myocardial infarction [ Time Frame: 5 years ]
  5. Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data [ Time Frame: Baseline ]
  6. Long-term mortality, cardiac mortality and incidence of acute myocardial infarction [ Time Frame: 5 years ]

Biospecimen Retention:   Samples With DNA
Plasma samples for biochemical markers. Whole blood samples for extraction of DNA for genetic analysis.

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients with stable coronary artery disease without previously known myocardial infarction or coronary intervention
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.
Contacts and Locations

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01257282


Contacts
Contact: Bertil Lindahl, professor +46 18 611 95 05 bertil.lindahl@ucr.uu.se

Locations
Sweden
Falu Hospital Recruiting
Falun, Sweden, SE - 791 82
Contact: Pär-Lennart Ågren    +46 23 492 000    par-lennart.agren@ltdalarna.se   
Principal Investigator: Pär-Lennart Ågren         
Gävle Hospital Recruiting
Gävle, Sweden, SE - 801 82
Contact: Lars Svennberg    +46 26 154 000    lars.svennberg@lg.se   
Principal Investigator: Lars Svennberg         
Linköping University Hospital Not yet recruiting
Linköping, Sweden, SE - 581 85
Contact: Peter Wodlin    +46 10 183 00 00    peter.wodlin@lio.se   
Principal Investigator: Peter Wodlin         
Danderyds Hospital Not yet recruiting
Stockholm, Sweden, SE - 182 88
Contact: Pia Lundman    +46 8 65 55 000    pia.lundman@ds.se   
Principal Investigator: Pia Lundman         
Uppsala University Hospital Recruiting
Uppsala, Sweden, SE-751 85
Contact: Bertil Lindahl    +46 18 611 95 05    bertil.lindahl@ucr.uu.se   
Principal Investigator: Bertil Lindahl, professor         
Örebro University Hospital Recruiting
Örebro, Sweden, SE-701 85
Contact: Stella Cizinsky    +46 19 602 10 00    stella.cizinsky@orebroll.se   
Principal Investigator: Stella Cizinsky         
Sponsors and Collaborators
Uppsala University
Investigators
Principal Investigator: Bertil Lindahl, professor Uppsala University
More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: professor Bertil Lindahl, Uppsala Clinical Research Centre
ClinicalTrials.gov Identifier: NCT01257282     History of Changes
Other Study ID Numbers: U-07-001
First Posted: December 9, 2010    Key Record Dates
Last Update Posted: December 9, 2010
Last Verified: December 2010

Additional relevant MeSH terms:
Coronary Artery Disease
Myocardial Ischemia
Coronary Disease
Angina Pectoris
Angina, Stable
Heart Diseases
Cardiovascular Diseases
Arteriosclerosis
Arterial Occlusive Diseases
Vascular Diseases
Chest Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms