NCT00338156

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
119

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2003

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2003

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

June 16, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 20, 2006

Completed
Last Updated

July 28, 2015

Status Verified

July 1, 2010

Enrollment Period

1 month

First QC Date

June 16, 2006

Last Update Submit

July 27, 2015

Conditions

Heart FailureMyocardial Infarct

Keywords

Left Ventricle RemodellingCollagen markersNeurohormonesCardiac MRI

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with risk of heart failure secondary to myocardial infarct.

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Stavanger University Hospital

Stavanger, NO-4011, Norway

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum Plasma

MeSH Terms

Conditions

Heart FailureMyocardial Infarction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Study Officials

  • Kenneth Dickstein, PhD

    Helse Stavanger HF

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 16, 2006

First Posted

June 20, 2006

Study Start

August 1, 2003

Primary Completion

September 1, 2003

Study Completion

September 1, 2003

Last Updated

July 28, 2015

Record last verified: 2010-07

Locations

NO(1)