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MR, Myocardial Infarct and Heart Failure (KoMPiS)

This study has been completed.
Sponsor:
Collaborators:
Helse Vest
Norwegian Foundation for Health and Rehabilitation
Norwegian Heart and Lung Patient Organization
Sparebank 1 SR-Bank Gavefond
Amersham Health
Information provided by:
Helse Stavanger HF
ClinicalTrials.gov Identifier:
NCT00465868
First received: April 24, 2007
Last updated: July 21, 2010
Last verified: June 2008
History of Changes
  Purpose

KoMPiS is a contrast aided cardiac magnetic resonance study of microvascular obstruction and left ventricular remodelling following acute revascularised anterior myocardial infarction. The study will monitor the included patients for 12 months following the acute myocardial infarct and collect data from MR scans and blood samples. The study is designed to demonstrate that obstruction of blood flow in the peripheral (small) vessels of the cardiac muscle is an important factor in the post-MI development of left ventricle dysfunction that occurs in many patients, despite of a successful re-opening of the occluded coronary artery that caused the MI.


Condition Intervention
Heart Failure, Congestive
 Procedure: PCI (percutaneous coronary intervention)

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Magnetic Resonance Imaging, Myocardial Infarction and Development of Heart Failure.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Helse Stavanger HF:

Biospecimen Retention:   Samples Without DNA

collagen markers, inflammatory markers and heart failure markers


Enrollment: 44
Study Start Date: December 2004
Study Completion Date: May 2007
Intervention Details:
    Procedure: PCI (percutaneous coronary intervention)
    Outcome of PCI following AMI
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Patients admited with AMi and rescue PCI.

Criteria

Inclusion Criteria:

  • Men or women > 18 years of age, non-child bearing potential
  • First time acute myocardial infarction, as determined by evidence of transmural ischemia in the ECG and a rise in cardiac-Troponin-T (TNT) > 0,1 (μg/l), followed by
  • A successful acute PCI of a single vessel disease with a proximal/mid left anterior descent artery (LAD), circumflex artery (RCX) or right coronary artery (RCA) lesion (the index PCI).

Exclusion Criteria:

  • Extensive cardiopulmonary resuscitation.
  • Haemodynamically unstable patients, unable to leave the coronary care unit for the CMR examination.
  • Use of fibrinolytics immediately prior to the index PCI.
  • Significant primary valve disease,
  • Autoimmune disease causing an increase in collagen turnover
  • Active cancer disease
  • Need for immunosuppressive treatment,
  • Significantly reduced liver function
  • Contraindications for performing a cardiac MRI-scan (claustrophobia, and implanted ferromagnetic devices, known allergic reactions to Omniscan™).
  • Inability to understand the consent form or cooperate during the 1 year follow up.
  • Comorbidity with poor prognosis.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00465868

Locations
Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011
Sponsors and Collaborators
Helse Stavanger HF
Helse Vest
Norwegian Foundation for Health and Rehabilitation
Norwegian Heart and Lung Patient Organization
Sparebank 1 SR-Bank Gavefond
Amersham Health
Investigators
Study Chair: Kenneth Dickstein, PhD Universiy of Bergen, Norway
  More Information

No publications provided by Helse Stavanger HF

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Kenneth Dickstein, professor, Stavanger University Hopital
ClinicalTrials.gov Identifier: NCT00465868     History of Changes
Other Study ID Numbers: StaHF461301
Study First Received: April 24, 2007
Last Updated: July 21, 2010
Health Authority: Norway:National Committee for Medical and Health Research Ethics
Norway: Directorate of Health

Keywords provided by Helse Stavanger HF:
Acute Myocardial Infarction
Coronary Revascularization
Microvascular Obstruction
 Cardiac MR
Collagen Turnover
Heart failure, post-mi

Additional relevant MeSH terms:
Heart Failure
Myocardial Infarction
Heart Diseases
 Cardiovascular Diseases
Myocardial Ischemia
Vascular Diseases

ClinicalTrials.gov processed this record on May 19, 2013