Skip to main content
OpenTrials
Completed

NCT Number: NCT00338156

Observational Study of the Remodelling Process Following Myocardial Infarct

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

Completed

Looking for future studies?

Notify Me

Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

Stavanger University Hospital

Stavanger, NO-4011, Norway

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Sponsors and collaborators

Lead sponsor

Helse Stavanger HF

Other Gov

Collaborators

  • Amersham Buchler, GmbH & Co KG
  • Helse Vest

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2003
Study completion
2003
First posted
Jun 20, 2006
Registry last updated
Jul 28, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.