Stable Angina PectorisPUMINCT01257282
Prevalence and Prognostic Value of Unrecognized Myocardial Injury in Stable Coronary Artery Disease (PUMI)
An observational study of Stable Angina Pectoris, run by Uppsala University at 6 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Stable Angina Pectoris
- How many people
- 275 participants
- Where
- 6 sitesSweden
- Study dates
- Sep 2007to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with stable coronary artery disease without previously known myocardial infarction or coronary intervention
Who may be able to join
- symptoms of stable angina pectoris according to the treating physician
- scheduled for coronary angiography
- written informed consent
Who cannot join
- 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.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Sweden6 sites, 6 recruiting
- Recruiting
Falu Hospital
Falun, SE - 791 82
Pär-Lennart Ågren, +46 23 492 000, par-lennart.agren@ltdalarna.se
Pär-Lennart Ågren
- Recruiting
Gävle Hospital
Gävle, SE - 801 82
Lars Svennberg, +46 26 154 000, lars.svennberg@lg.se
Lars Svennberg
- Not yet recruiting
Linköping University Hospital
Linköping, SE - 581 85
Peter Wodlin, +46 10 183 00 00, peter.wodlin@lio.se
Peter Wodlin
- Recruiting
Örebro University Hospital
Örebro, SE-701 85
Stella Cizinsky, +46 19 602 10 00, stella.cizinsky@orebroll.se
Stella Cizinsky
- Not yet recruiting
Danderyds Hospital
Stockholm, SE - 182 88
Pia Lundman, +46 8 65 55 000, pia.lundman@ds.se
Pia Lundman
- Recruiting
Uppsala University Hospital
Uppsala, SE-751 85
Bertil Lindahl, +46 18 611 95 05, bertil.lindahl@ucr.uu.se
Bertil Lindahl, professor
About this study
Official title: 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.
Read the 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).
- Conditions
- Stable Angina Pectoris
- Medical subject headings
- Angina, Stable
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina.
Measured: 24 months
Secondary outcomes (6)
Presence of unrecognized myocardial infarction
Measured: Baseline
Size and localisation of unrecognized myocardial infarction
Measured: Baseline
Degree and localization of artherosclerotic lesions at a coronary angiogram
Measured: Baseline
Procedure related acute myocardial infarction
Measured: 5 years
Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data
Measured: Baseline
Long-term mortality, cardiac mortality and incidence of acute myocardial infarction
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2010 (estimated)
- Study startSep 2007
- Primary completionMar 2013 (estimated)
- Study completionMar 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Stable Angina PectorisStudies of the same condition, open and under way.
- More trials run by Uppsala UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 275 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Uppsala University
- Sponsor type
- University, hospital or other
- Investigators
- Bertil Lindahl, professor, Principal investigator, Uppsala University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01257282
- Sponsor's protocol ID
- U-07-001
- Acronym
- PUMI
- Status last verified
- Dec 2010
- First submitted
- 6 Dec 2010
- Last updated
- 9 Dec 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26885831Nordenskjold 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.
PubMed 26828531Hammar 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.
PubMed 26585508
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.
- ClinicalTrials.gov ID
- NCT01257282
- Acronym / sponsor ID
- PUMI / U-07-001
- Conditions
- Stable Angina Pectoris
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 275 participants (estimated)
- Lead sponsor
- Uppsala UniversityUniversity, hospital or other
- Study start
- Sep 2007
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Mar 2013 (estimated)
- First posted
- 9 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with stable coronary artery disease without previously known myocardial infarction or coronary intervention
Key inclusion criteria (3 listed)
- symptoms of stable angina pectoris according to the treating physician
- scheduled for coronary angiography
- written informed consent
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
6 secondary outcomes
Presence of unrecognized myocardial infarction
Time frame: Baseline
Size and localisation of unrecognized myocardial infarction
Time frame: Baseline
Degree and localization of artherosclerotic lesions at a coronary angiogram
Time frame: Baseline
Procedure related acute myocardial infarction
Time frame: 5 years
Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data
Time frame: Baseline
Long-term mortality, cardiac mortality and incidence of acute myocardial infarction
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2010.
- Derived from this study: PubMed 26885831Nordenskjold 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.
- Derived from this study: PubMed 26828531Nordenskjold 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.
- Derived from this study: PubMed 26585508Hammar 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bertil Lindahl, professor principal investigator
Uppsala University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Stable Angina Pectoris, run by Uppsala University at 6 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 9 Dec 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Bertil Lindahl, professor (+46 18 611 95 05, bertil.lindahl@ucr.uu.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01257282, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2010.