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

Stable Angina Pectoris Clinical Trial

— PUMI  

Official title:

Prevalence and Prognostic Value of Unrecognised Myocardial Injury in Stable Coronary Artery Disease (PUMI)- a Multicenter, Observational Cohort Study.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01257282
• Other study ID #: U-07-001
• Status: Recruiting
• Phase: N/A
• First received: December 6, 2010
• Last updated: December 8, 2010
• Start date: September 2007
• Est. completion date: March 2013

Study information

• Verified date: December 2010
• Source: Uppsala University
• Contact: Bertil Lindahl, professor
• Phone: +46 18 611 95 05
• Email: bertil.lindahl[@]ucr.uu.se
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Observational

Clinical 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 275
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Angina Pectoris
• Angina, Stable
• Coronary Artery Disease
• Coronary Disease
• Myocardial Ischemia
• Stable Angina Pectoris

Locations

Country	Name	City	State
Sweden	Falu Hospital	Falun
Sweden	Gävle Hospital	Gävle
Sweden	Linköping University Hospital	Linköping
Sweden	Örebro University Hospital	Örebro
Sweden	Danderyds Hospital	Stockholm
Sweden	Uppsala University Hospital	Uppsala

Sponsors (1)

Lead Sponsor	Collaborator
Uppsala University

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac events defined as a composite of death, resuscitated cardiac arrest, spontaneous acute myocardial infarction and hospitalisation for congestive heart failure or unstable angina.		24 months	No
Secondary	Presence of unrecognized myocardial infarction		Baseline	No
Secondary	Size and localisation of unrecognized myocardial infarction		Baseline	No
Secondary	Degree and localization of artherosclerotic lesions at a coronary angiogram		Baseline	No
Secondary	Procedure related acute myocardial infarction		5 years	No
Secondary	Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data		Baseline	No
Secondary	Long-term mortality, cardiac mortality and incidence of acute myocardial infarction		5 years	No