Acute Myocardial InfarctionPhase 3NCT00430885
Effect of Intravenous Immunglobulin (IVIG) After Myocardial Infarction
A Phase 3 study testing Octagam (IVIG) in people with Acute Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 18 years
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- Octagam (IVIG)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 siteNorway
- Study dates
- Feb 2007to May 2010
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 18 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Phase III Study of Intravenous Immunglobulin (IVIG) in Patients With Heart Failure After Myocardial Infarction
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.
Read the detailed description
This double-blind placebo-controlled study represents a new approach to cardiovascular disease. The project deals with unresolved issues in the intersection between cardiology, immunology and molecular biology.
IVIG/placebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months. Change in left ventricular remodeling will be assessed at baseline, and 6 and 12 months with MRI and echocardiography.
The objectives are:
- The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function: LV remodeling will be evaluated with magnetic resonance imaging (MRI) which offers an unsurpassed precision in the measurements of heart volumes and function. End points will be LV-end systolic and diastolic volume (LVESV, LVEDV), regional wall motion score index (WMSI), and LV-ejection fraction (LV-EF).
- The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide (BNP). BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20.
- The tertiary objective of this study is to evaluate the effect on IVIG on:
- Quality of life. b. Effect on New York Heart Association (NYHA) functional class. c. Effect on immunological variables. i. Inflammatory cytokines such as TNF-alpha, IL-6, IL-18. ii. Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii. Chemokines such as monocyte chemoattractant protein 1, IL-8 and CCL21. iv. Regulators of hypertrophy such as matrix metalloproteinases, their endogenous inhibitors (i.e., TIMPs) and procollagen III N-terminal.
- Effect on neurohormones. e. Withdrawals. f. Side effects.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Octagam (IVIG)
- Keywords
- Heart failure, Myocardial infarction, Patients with acute myocardial infarction
- Medical subject headings
- Heart Failure, Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Octagam (IVIG)Drug
Also called Intravenous immunoglobulin 0.4 g/kg given as infusion
Intravenous immunoglobulin 0.4 g/kg given as infusion
| Study group | Role | What they receive |
|---|---|---|
| Saline | Placebo comparator | Not described Receives: Drug: Octagam (IVIG) |
| Octagam (IVIG) | Experimental | Octagam (IVIg) is intravenous immunglobulin Receives: Drug: Octagam (IVIG) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI
Measured: 2009
Secondary outcomes (1)
2. Effect on IVIG on B-Type Natriuretic Peptide (BNP).
Measured: 2009
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2007 (estimated)
- Study startFeb 2007
- Primary completionMay 2009
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Acute Myocardial InfarctionStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Stavanger HF
- Responsible party
- Principal investigator, Lars Gullestad, Oslo University Hospital
- Investigators
- Lars Gullestad, MD, PhD, Principal investigator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430885
- Sponsor's protocol ID
- 175464/V50
- Other IDs
- NFR 175464/V50
- Status last verified
- Jan 2014
- First submitted
- 1 Feb 2007
- Last updated
- 27 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 23046599
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase III Study of Intravenous Immunglobulin (IVIG) in Patients With Heart Failure After Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00430885
- Acronym / sponsor ID
- 175464/V50
- Conditions
- Acute Myocardial Infarction
- Keywords
- Heart failure, Myocardial infarction, Patients with acute myocardial infarction
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 62 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Stavanger HF
- Study start
- Feb 2007
- Primary completion
- May 2009 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 2 Feb 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This double-blind placebo-controlled study represents a new approach to cardiovascular disease. The project deals with unresolved issues in the intersection between cardiology, immunology and molecular biology.
IVIG/placebo will be given as an induction therapy for 5 days and thereafter as monthly infusions for 5 months. Change in left ventricular remodeling will be assessed at baseline, and 6 and 12 months with MRI and echocardiography.
The objectives are:
- The primary objective of this study is to evaluate the effect on IVIG on LV remodeling and function: LV remodeling will be evaluated with magnetic resonance imaging (MRI) which offers an unsurpassed precision in the measurements of heart volumes and function. End points will be LV-end systolic and diastolic volume (LVESV, LVEDV), regional wall motion score index (WMSI), and LV-ejection fraction (LV-EF).
- The secondary objective of this study is to evaluate the effect on IVIG on the myocardial marker B-Type Natriuretic Peptide (BNP). BNP is a sensitive marker of the degree of HF besides being a prognostic indicator 18-20.
- The tertiary objective of this study is to evaluate the effect on IVIG on:
- Quality of life. b. Effect on New York Heart Association (NYHA) functional class. c. Effect on immunological variables. i. Inflammatory cytokines such as TNF-alpha, IL-6, IL-18. ii. Anti-inflammatory cytokines such as IL-10 and transforming growth factor beta iii. Chemokines such as monocyte chemoattractant protein 1, IL-8 and CCL21. iv. Regulators of hypertrophy such as matrix metalloproteinases, their endogenous inhibitors (i.e., TIMPs) and procollagen III N-terminal.
- Effect on neurohormones. e. Withdrawals. f. Side effects.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Saline | Placebo comparator | Drug: Octagam (IVIG) |
| Octagam (IVIG) | Experimental | Drug: Octagam (IVIG)Octagam (IVIg) is intravenous immunglobulin |
Who may qualify
- Ages
- 18 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Octagam (IVIG)Also: Intravenous immunoglobulin 0.4 g/kg given as infusionIntravenous immunoglobulin 0.4 g/kg given as infusion | Drug | Octagam (IVIG), Saline |
Primary outcome
1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI
Time frame: 2009
1 secondary outcome
2. Effect on IVIG on B-Type Natriuretic Peptide (BNP).
Time frame: 2009
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2014.
- Derived from this study: PubMed 23046599Gullestad 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lars Gullestad, MD, PhD principal investigator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Octagam (IVIG) in people with Acute Myocardial Infarction, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. The effect on IVIG on LV remodeling (volume and ejection fraction) and function as assessed by MRI (time frame: 2009). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00430885, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2014.