Observational Study of the Remodelling Process Following Myocardial Infarct - Full Text View

Sponsors and Collaborators:	Stavanger Health Research Helse Vest Amersham
Information provided by:	Stavanger Health Research
ClinicalTrials.gov Identifier:	NCT00338156

Purpose

This study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in patients 3 years following a myocardial infarction.

Condition
Heart Failure Myocardial Infarct

MedlinePlus related topics: Heart Attack Heart Failure Scars

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective/Prospective Study
Official Title:	Assessment of the Relationship Between Collagen Turnover, Left Ventricular Remodelling and Myocardial Scarring Assessed by Cardiac Magnetic Resonance and Neurohumoral Activation in Patients With Previous Myocardial Infarction

Further study details as provided by Stavanger Health Research:

Estimated Enrollment:	119
Study Start Date:	August 2003
Estimated Study Completion Date:	September 2003

Detailed Description:

A multinational trial compared losartan vs. captopril in 5477 postinfarction patients with symptoms of heart failure and/or evidence of left ventricular dysfunction. The trial was terminated in 2002 and the results of the main trial have been published. In this trial, a collagen and neurohumoral substudy was performed to assess the importance of collagen turnover in this population. A total of 235 patients were included from 18 centres. Blood was taken at randomisation, 1 month, 1 year and 2 years.

The present study will recruit surviving patients among the 119 individuals that were randomised to the neurohumoral substudy at the Stavanger University Hospital. The study will assess the relationship between collagen turnover, neurohormonal activation, scarring and left ventricle remodelling in these patients about 3 years following the index myocardial infarction.

The data collected at the 3-year follow-up visit will be compared to data from the initial study.

Eligibility

Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Participation in the previous neurohormonal substudy of the OPTIMAAL trial
Willingness to participate in the present study and ability to understand and sign the written informed consent

Exclusion Criteria:

Myocardial infarction within 3 months of visit 1.
Significant primary valve disease, confirmed by ECHO cardiography,
Autoimmune disease likely to cause an increase in collagen turnover
Active cancer disease
Immunosuppressive treatment,
Significantly reduced liver function
Contraindications for performing a cardiac MRI scan (including claustrophobia, implanted ferromagnetic devices or known allergic reactions to Omniscan™).
Inability to cooperate during the 1 month follow up period.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00338156

Locations

Norway
Stavanger University Hospital
Stavanger, Norway, NO-4011

Sponsors and Collaborators

Stavanger Health Research

Helse Vest

Amersham

Investigators

Principal Investigator:

Kenneth Dickstein, PhD

Stavanger University Hospital

More Information

Study ID Numbers:	StaHF461302, Helse Vest 911017
Study First Received:	June 16, 2006
Last Updated:	February 26, 2007
ClinicalTrials.gov Identifier:	NCT00338156
Health Authority:	Norway: Norwegian Medicines Agency

Keywords provided by Stavanger Health Research:

Left Ventricle Remodelling
Collagen markers
Neurohormones
Cardiac MRI

Study placed in the following topic categories:

Heart Failure
Heart Diseases
Myocardial Ischemia
Vascular Diseases

Ischemia
Infarction
Myocardial Infarction
Cicatrix

Additional relevant MeSH terms:

Cardiovascular Diseases

ClinicalTrials.gov processed this record on January 14, 2009