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

NCT ID: NCT01257282

Last Updated: 2010-12-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

275 participants

Study Classification

OBSERVATIONAL

Study Start Date

2007-09-30

Study Completion Date

2013-03-31

Brief Summary

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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

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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).

Conditions

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Stable Angina Pectoris

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Uppsala University

OTHER

Sponsor Role lead

Responsible Party

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Uppsala Clinical Research Centre

Principal Investigators

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Bertil Lindahl, professor

Role: PRINCIPAL_INVESTIGATOR

Uppsala University

Locations

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Falu Hospital

Falun, , Sweden

Site Status RECRUITING

Gävle Hospital

Gävle, , Sweden

Site Status RECRUITING

Linköping University Hospital

Linköping, , Sweden

Site Status NOT_YET_RECRUITING

Örebro University Hospital

Örebro, , Sweden

Site Status RECRUITING

Danderyds Hospital

Stockholm, , Sweden

Site Status NOT_YET_RECRUITING

Uppsala University Hospital

Uppsala, , Sweden

Site Status RECRUITING

Countries

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Sweden

Central Contacts

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Bertil Lindahl, professor

Role: CONTACT

Phone: +46 18 611 95 05

Email: [email protected]

Facility Contacts

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Pär-Lennart Ågren

Role: primary

Lars Svennberg

Role: primary

Peter Wodlin

Role: primary

Stella Cizinsky

Role: primary

Pia Lundman

Role: primary

Bertil Lindahl

Role: primary

References

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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.

Reference Type DERIVED
PMID: 26885831 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26828531 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26585508 (View on PubMed)

Other Identifiers

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U-07-001

Identifier Type: -

Identifier Source: org_study_id