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CompletedNCT00338156Updated Jul 28, 2015

Observational Study of the Remodelling Process Following Myocardial Infarct

An observational study in Heart Failure and Myocardial Infarct, sponsored by Helse Stavanger HF. Completed at 1 site in Norway. Per ClinicalTrials.gov, last updated 2015-07-28.

Sponsored by Helse Stavanger HF · Observational

Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
119
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Heart Failure
  • Myocardial Infarct

Keywords

  • Left Ventricle Remodelling
  • Collagen markers
  • Neurohormones
  • Cardiac MRI
03

In context

Myocardial Infarction

2,744 studies on the registry are indexed under Myocardial Infarction; 418 are open to participants now.

This study's enrollment of 119 is below the median of 500 across 983 observational studies indexed under Myocardial Infarction.

Browse Myocardial Infarction studies →

Lead sponsor

Helse Stavanger HF is the lead sponsor of 93 studies on the registry; 17 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Patients with risk of heart failure secondary to myocardial infarct.

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

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.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
119 participants (actual)
Biospecimen retention
Samples without dna
06

Study locations

1 site
  • Stavanger University Hospital
    Stavanger, NO-4011, Norway
07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00338156
Lead sponsor
Helse Stavanger HF
Collaborators
Helse Vest, Amersham Buchler, GmbH & Co KG
Responsible party
Sponsor
First posted
Jun 20, 2006
Start date
Aug 2003
Primary completion
Sep 2003
Completion
Sep 2003
Last update
Jul 28, 2015

Study contacts

Kenneth Dickstein, PhD
principal investigator · Helse Stavanger HF

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2010. You cannot join it, but the record below documents what was studied.

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