AzTrials
AzTrials

Acute Myocardial InfarctionPhase 4NCT00157768

IRIS : Use of Implantable Defibrillator in High-risk Patients Early After Acute Myocardial Infarction

A Phase 4 study testing Implantable cardioverter defibrillator in people with Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Acute Myocardial Infarction
What is being tested?
Implantable cardioverter defibrillator
Type of treatment
Medical device
How many people
900 participants
Where
1 siteNetherlands
Study dates
9 Jun 1999to 15 Oct 2007
Phase
Phase 4
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 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • acute myocardial infarction (5-31 days)
  • fulfill requirement I and/or II :
  • I first ECG heart rate >= 90 bpm (within day 1-2 post MI) and LVEF <= 40 % (within day 5-31 post-MI)
  • II >= 1 episode of non-sustained ventricular tachycardia >= 150 bpm (on Holter, within 5-31 days post-MI)

Who cannot join

  • Patients with ventricular arrhythmia, requiring clinical therapy, before the index infarction or more than 48 h later
  • Patients with therapy refractory heart failure (NYHA IV)
  • Myocardial infarction older than 31 days
  • First-ECG not available or was recorded more than 48 h after the symptom onset.
  • Patients with indication for CABG operation before inclusion
  • Patients with cerebral organic psycho syndrome
Show all 13Show fewer
  • Secondary diseases which clearly limit life expectancy
  • Patient with right sided artificial heart valve
  • Patients with poor compliance
  • Patients who are participating in another study
  • Unstable clinical condition
  • Pregnancy
  • No consent from patient

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Medtronic Bakken Research Center B.V.

    Maastricht

Other trials in Netherlands

About this study

Official title: IRIS - Immediate Risk-stratification Improves Survival - Joint Study of the German University Hospitals and German Society of Leading Cardiological Hospital Physicians (ALKK)

Of the patients who survive hospitalization after an acute myocardial infarction, ca. 10% die of sudden cardiac death in the following 2 years. The prognosis appears not improved by medication with antiarrhythmics (class I/III). A positive effect of beta-blockers (Metoprolol CR/Zok) on total mortality after myocardial infarction in patients with heart failure is well established. On the other hand, an implantable defibrillator (ICD) proved to be superior to medication when used for secondary prevention in patients after cardiac arrest. The question arises whether ICD therapy is also effective in primary prevention in high risk patients after acute myocardial infarction. This study determines if patients, who were defined as high risk patients in the early post infarction phase by means of noninvasive methods, benefit from primary prevention by means of an ICD. Special emphasis is put on an individual optimization of the infarction therapy, including beta-blockers.

Being tested
Implantable cardioverter defibrillator
Keywords
Acute myocardial infarction, Non-sustained ventricular tachycardia, Left ventricular dysfunction, Implantable cardioverter defibrillator, ICD, Risk-stratification
Medical subject headings
Ventricular Dysfunction, Left

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Implantable cardioverter defibrillatorDevice

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The null hypothesis is that all cause mortality in the treatment (Implantable cardioverter defibrillator =ICD) and control group is identical. The alternative hypothesis is that all cause mortality in the ICD group and control group is different.

Secondary outcomes (2)

  1. Type of death, Arrhythmic events, Serious cardiac and cerebral interventions,

  2. Device-related complications, Hospitalizations, Quality of life

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Sep 2005 (estimated)
  2. Study start9 Jun 1999
  3. Primary completion15 Oct 2007
  4. Study completion15 Oct 2007

Resources

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 4
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
900 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00157768
Sponsor's protocol ID
Medtronic_BRC_CRM_002
Status last verified
Oct 2018
First submitted
8 Sep 2005
Last updated
3 Jul 2025
Results posted
No

Publications

  • Steinbeck G, Andresen D, Seidl K, Brachmann J, Hoffmann E, Wojciechowski D, Kornacewicz-Jach Z, Sredniawa B, Lupkovics G, Hofgartner F, Lubinski A, Rosenqvist M, Habets A, Wegscheider K, Senges J; IRIS Investigators. Defibrillator implantation early after myocardial infarction. N Engl J Med. 2009 Oct 8;361(15):1427-36. doi: 10.1056/NEJMoa0901889.

    PubMed 19812399

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Implantable cardioverter defibrillator in people with Acute Myocardial Infarction, run by Medtronic Cardiac Rhythm and Heart Failure at 1 site in Netherlands.

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 4 inclusion and 13 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 3 Jul 2025. 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 Netherlands. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

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?

The null hypothesis is that all cause mortality in the treatment (Implantable cardioverter defibrillator =ICD) and control group is identical. The alternative hypothesis is that all cause mortality in the ICD group and control group is different.. 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 NCT00157768, 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 3 Jul 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in