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

December 8, 2010 updated by: Uppsala University

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

275

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Falun, Sweden, SE - 791 82
        • Recruiting
        • Falu Hospital
        • Contact:
        • Principal Investigator:
          • Pär-Lennart Ågren
      • Gävle, Sweden, SE - 801 82
        • Recruiting
        • Gävle Hospital
        • Contact:
        • Principal Investigator:
          • Lars Svennberg
      • Linköping, Sweden, SE - 581 85
        • Not yet recruiting
        • Linköping University Hospital
        • Contact:
        • Principal Investigator:
          • Peter Wodlin
      • Stockholm, Sweden, SE - 182 88
        • Not yet recruiting
        • Danderyds Hospital
        • Contact:
        • Principal Investigator:
          • Pia Lundman
      • Uppsala, Sweden, SE-751 85
        • Recruiting
        • Uppsala University Hospital
        • Contact:
        • Principal Investigator:
          • Bertil Lindahl, professor
      • Örebro, Sweden, SE-701 85
        • Recruiting
        • Örebro University Hospital
        • Contact:
        • Principal Investigator:
          • Stella Cizinsky

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time 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.
Time Frame: 24 months
24 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Investigators

  • Principal Investigator: Bertil Lindahl, professor, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2007

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

March 1, 2013

Study Registration Dates

First Submitted

December 6, 2010

First Submitted That Met QC Criteria

December 8, 2010

First Posted (Estimate)

December 9, 2010

Study Record Updates

Last Update Posted (Estimate)

December 9, 2010

Last Update Submitted That Met QC Criteria

December 8, 2010

Last Verified

December 1, 2010

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U-07-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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