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
Recruitment status was Recruiting
Sponsor:
Uppsala University
Information provided by:
Uppsala University
ClinicalTrials.gov Identifier:
NCT01257282
First received: December 6, 2010
Last updated: December 8, 2010
Last verified: December 2010
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Purpose
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 |
|---|
|
Stable Angina Pectoris |
| Study Type: | Observational |
| Study Design: | 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. |
Resource links provided by NLM:
Further study details as provided by Uppsala University:
Primary Outcome Measures:
- 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 ]
Secondary Outcome Measures:
- 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 ]
Biospecimen Retention: Samples With DNA
Plasma samples for biochemical markers. Whole blood samples for extraction of DNA for genetic analysis.
| Estimated Enrollment: | 275 |
| Study Start Date: | September 2007 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | March 2013 (Final data collection date for primary outcome measure) |
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| Genders Eligible for Study: | Both |
| 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
Please refer to this study by its ClinicalTrials.gov identifier: 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
No publications provided
| Responsible Party: | professor Bertil Lindahl, Uppsala Clinical Research Centre |
| ClinicalTrials.gov Identifier: | NCT01257282 History of Changes |
| Other Study ID Numbers: | U-07-001 |
| Study First Received: | December 6, 2010 |
| Last Updated: | December 8, 2010 |
| Health Authority: | Sweden: Regional Ethical Review Board |
Additional relevant MeSH terms:
|
Angina Pectoris Coronary Artery Disease Myocardial Ischemia Coronary Disease Heart Diseases Cardiovascular Diseases |
Vascular Diseases Chest Pain Pain Signs and Symptoms Arteriosclerosis Arterial Occlusive Diseases |
ClinicalTrials.gov processed this record on May 22, 2013