MR, Myocardial Infarct and Heart Failure - Full Text View

MR, Myocardial Infarct and Heart Failure (KoMPiS)

This study has been completed.

Sponsors and Collaborators:	Stavanger Health Research Stavanger University Hospital Helse Vest RHF Norwegian Foundation for Health and Rehabilitation The Norwegian Association of Heart and Lung Patients SR-Bank Gavefond Amersham
Information provided by:	Stavanger Health Research
ClinicalTrials.gov Identifier:	NCT00465868

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)

MedlinePlus related topics: Heart Attack Heart Failure MRI Scans

Drug Information available for: Acetylsalicylic acid

U.S. FDA Resources

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

Further study details as provided by Stavanger Health Research:

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

collagen markers, inflammatory markers and heart failure markers

Enrollment:	44
Study Start Date:	December 2004
Study Completion Date:	May 2007

Intervention Details:

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

Stavanger Health Research

Stavanger University Hospital

Helse Vest RHF

Norwegian Foundation for Health and Rehabilitation

The Norwegian Association of Heart and Lung Patients

SR-Bank Gavefond

Amersham

Investigators

Study Chair:

Kenneth Dickstein, PhD

Universiy of Bergen, Norway

More Information

Responsible Party:	Stavanger University Hopital ( Kenneth Dickstein, professor )
Study ID Numbers:	StaHF461301
Study First Received:	April 24, 2007
Last Updated:	June 9, 2008
ClinicalTrials.gov Identifier:	NCT00465868
Health Authority:	Norway: The National Committees for Research Ethics in Norway; Norway: Directorate for Health and Social Affairs

Keywords provided by Stavanger Health Research:

Acute Myocardial Infarction
Coronary Revascularization
Microvascular Obstruction

Cardiac MR
Collagen Turnover
Heart failure, post-mi

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Aspirin
Myocardial Ischemia

Vascular Diseases
Ischemia
Infarction
Myocardial Infarction

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 16, 2009