NCT00430885

Brief Summary

The instigators hypothesize that IVIG, given in the acute phase following MI in patients at risk for developing HF, will improve cardiac performance, and by attenuating cardiac remodeling in this phase, such therapy will prevent the development of chronic HF resulting in long term beneficial effect also after the therapy has been stopped.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Feb 2007

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

February 1, 2007

Completed
Same day until next milestone

Study Start

First participant enrolled

February 1, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 2, 2007

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2010

Completed
Last Updated

January 27, 2014

Status Verified

January 1, 2014

Enrollment Period

2.2 years

First QC Date

February 1, 2007

Last Update Submit

January 24, 2014

Conditions

Acute Myocardial Infarction

Keywords

Heart failureMyocardial infarctionPatients with acute myocardial infarction

Outcome Measures

Primary Outcomes (1)

  • 1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI

    2009

Secondary Outcomes (1)

  • 2. Effect on IVIG on B-Type Natriuretic Peptide (BNP).

    2009

Study Arms (2)

Saline

PLACEBO COMPARATOR
Drug: Octagam (IVIG)

Octagam (IVIG)

EXPERIMENTAL

Octagam (IVIg) is intravenous immunglobulin

Drug: Octagam (IVIG)

Interventions

Octagam (IVIG)DRUG

Intravenous immunoglobulin 0.4 g/kg given as infusion

Also known as: Intravenous immunoglobulin 0.4 g/kg given as infusion
Octagam (IVIG)Saline

Eligibility Criteria

Age18 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Age of 18-80 years
  • Have a recent MI (\<5days)
  • Have ASAT \>100 U/L or CKMB \> 50 U/L.
  • Have LVEF \<40%.
  • Are on optimal medical treatment and considered unsuitable for surgical intervention.

You may not qualify if:

  • Evidence of unstable disease, concomitant ischemia or unstable angina during the hospitalization.
  • Significant concomitant disease such as infections, pulmonary disease or connective tissue disease.
  • Participating in other studies.
  • Inability to participate.
  • Diseases that require surgery.
  • Planned revascularisation.
  • Known hypersensitivity to IVIG.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Rikshospitalet University Hospital

Oslo, Norway

Location

Related Publications (1)

  • Gullestad L, Orn S, Dickstein K, Eek C, Edvardsen T, Aakhus S, Askevold ET, Michelsen A, Bendz B, Skardal R, Smith HJ, Yndestad A, Ueland T, Aukrust P. Intravenous immunoglobulin does not reduce left ventricular remodeling in patients with myocardial dysfunction during hospitalization after acute myocardial infarction. Int J Cardiol. 2013 Sep 20;168(1):212-8. doi: 10.1016/j.ijcard.2012.09.092. Epub 2012 Oct 6.

    PMID: 23046599DERIVED

MeSH Terms

Conditions

Heart FailureMyocardial Infarction

Interventions

OctagamImmunoglobulins, Intravenous

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesMyocardial IschemiaVascular DiseasesInfarctionIschemiaPathologic ProcessesPathological Conditions, Signs and SymptomsNecrosis

Intervention Hierarchy (Ancestors)

Immunoglobulin GImmunoglobulin IsotypesAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lars Gullestad, MD, PhD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

February 1, 2007

First Posted

February 2, 2007

Study Start

February 1, 2007

Primary Completion

May 1, 2009

Study Completion

May 1, 2010

Last Updated

January 27, 2014

Record last verified: 2014-01

Locations

NO(1)