NCT01257282

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
275

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Sep 2007

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2007

Completed
3.3 years until next milestone

First Submitted

Initial submission to the registry

December 6, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 9, 2010

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

December 9, 2010

Status Verified

December 1, 2010

Enrollment Period

5.5 years

First QC Date

December 6, 2010

Last Update Submit

December 8, 2010

Conditions

Stable Angina Pectoris

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (6)

  • Presence of unrecognized myocardial infarction

    Baseline

  • Size and localisation of unrecognized myocardial infarction

    Baseline

  • Degree and localization of artherosclerotic lesions at a coronary angiogram

    Baseline

  • Procedure related acute myocardial infarction

    5 years

  • Left ventricular mass and dimensions, levels of troponin and other biochemical markers, electrocardiography (ECG), anthropometric data

    Baseline

  • +1 more secondary outcomes

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • symptoms of stable angina pectoris according to the treating physician
  • scheduled for coronary angiography
  • written informed consent

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Falu Hospital

Falun, SE - 791 82, Sweden

RECRUITING

Gävle Hospital

Gävle, SE - 801 82, Sweden

RECRUITING

Linköping University Hospital

Linköping, SE - 581 85, Sweden

NOT YET RECRUITING

Örebro University Hospital

Örebro, SE-701 85, Sweden

RECRUITING

Danderyds Hospital

Stockholm, SE - 182 88, Sweden

NOT YET RECRUITING

Uppsala University Hospital

Uppsala, SE-751 85, Sweden

RECRUITING

Related Publications (3)

  • 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.

    PMID: 26885831DERIVED

  • 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.

    PMID: 26828531DERIVED

  • 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.

    PMID: 26585508DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Plasma samples for biochemical markers. Whole blood samples for extraction of DNA for genetic analysis.

MeSH Terms

Conditions

Angina, Stable

Condition Hierarchy (Ancestors)

Angina PectorisMyocardial IschemiaHeart DiseasesCardiovascular DiseasesVascular DiseasesChest PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Bertil Lindahl, professor

    Uppsala University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Bertil Lindahl, professor

CONTACT

+46 18 611 95 05bertil.lindahl@ucr.uu.se

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 6, 2010

First Posted

December 9, 2010

Study Start

September 1, 2007

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

December 9, 2010

Record last verified: 2010-12

Locations

SE(6)