Non-ST-elevation Myocardial InfarctionIDEAL NSTEMINCT00954668
ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
A study testing immediate angiography and revascularization and early invasive angiography in people with Non-ST-elevation Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
Trial summary
Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Non-ST-elevation Myocardial Infarction
- What is being tested?
- immediate angiography and revascularization and early invasive angiography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteGermany
- Study dates
- 1 Jan 2009to 1 Jan 2009
- Phase
- Interventional
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- NSTEMI with
- ischemic symptoms >10 minutes within 24 h
- elevated troponin or creatine kinase above the upper limit of normal
- ST-segment depression or transient ST-segment elevation, T-wave inversion
- informed consent.
Who cannot join
- Age < 18 years
- Age > 90 years
- persistent angina
- hemodynamic instability
- overt congestive heart failure
- life-threatening arrhythmias
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- STEMI
- limited life-expectancy < 6 months
- chronic oral anticoagulation
- fibrinolysis < 48 hours
- PCI < 14 days
- contraindication for treatment with glycoprotein IIb/IIIa inhibitors, heparin, aspirin and clopidogrel
- recent major trauma or surgery
Trial locations and contacts
1 site in 1 country.
About this study
Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.
- Conditions
- Non-ST-elevation Myocardial Infarction
- Being tested
- immediate angiography and revascularization, early invasive angiography
- Keywords
- Non-ST-elevation myocardial infarction, angiography, percutaneous coronary intervention, timing
- Medical subject headings
- Non-ST Elevated Myocardial Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate angiography and revascularizationProcedure or surgery
immediate angiography < 2 hours after randomization
early invasive angiographyProcedure or surgery
early invasive angiography 12-72 h after randomization
| Study group | Role | What they receive |
|---|---|---|
| immediate angiography | Experimental | Immediate invasive angiography < 2 h after randomization Receives: Procedure: immediate angiography and revascularization |
| early invasive angiography | Active comparator | early invasive angiography 12-72 h after randomization Receives: Procedure: early invasive angiography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Death and non-fatal recurrent infarction
Measured: 6 months
Secondary outcomes (1)
Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2009 (estimated)
- Study start1 Jan 2009
- Primary completion1 Jan 2009
- Study completion1 Jan 2009
Why it stopped: No funding
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-ST-elevation Myocardial InfarctionStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Collaborators
- Stiftung Institut fuer Herzinfarktforschung
- Responsible party
- Principal investigator, Holger Thiele, University of Leipzig
- Investigators
- Holger Thiele, MD, Study chair, Heart Center Leipzig - University HospitalUwe Zeymer, MD, Study director, Institut für Herzinfarktforschung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00954668
- Sponsor's protocol ID
- IDEAL NSTEMI 1
- Acronym
- IDEAL NSTEMI
- Status last verified
- Jul 2018
- First submitted
- 6 Aug 2009
- Last updated
- 6 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ImmeDiate Versus EArLy Invasive Approach in Non-ST-Elevation Myocardial Infarction (IDEAL NSTEMI)
- ClinicalTrials.gov ID
- NCT00954668
- Acronym / sponsor ID
- IDEAL NSTEMI / IDEAL NSTEMI 1
- Conditions
- Non-ST-elevation Myocardial Infarction
- Keywords
- Non-ST-elevation myocardial infarction, angiography, percutaneous coronary intervention, timing
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No funding
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Collaborators
- Stiftung Institut fuer Herzinfarktforschung
- Study start
- 1 Jan 2009 (actual)
- Primary completion
- 1 Jan 2009 (actual)
- Study completion
- 1 Jan 2009 (actual)
- First posted
- 7 Aug 2009 (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.
Of estimated 140,000 cases of acute myocardial infarction admitted to hospitals in Germany per year, approximately 50% present with Non-ST-elevation myocardial infarction (NSTEMI). The currently available evidence led to current guideline recommendations that a systematic approach of immediate angiography in NSTEMI patients stabilized with contemporary antiplatelet treatment is not mandatory. However, this immediate invasive approach is appealing because it allows treating the underlying cause (the plaque rupture) as early as possible with subsequent reduction of death and recurrent myocardial infarction. In the IDEAL NSTEMI trial we test an immediate invasive approach (<2 h) with an approach 12-72 h according top guidelines with respect to 6 months death and mortality.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| immediate angiography | Experimental | Procedure: immediate angiography and revascularizationImmediate invasive angiography < 2 h after randomization |
| early invasive angiography | Active comparator | Procedure: early invasive angiographyearly invasive angiography 12-72 h after randomization |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- NSTEMI with
Key exclusion criteria (13 listed)
- Age < 18 years
- Age > 90 years
- persistent angina
- hemodynamic instability
- overt congestive heart failure
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 |
|---|---|---|
| immediate angiography and revascularizationimmediate angiography < 2 hours after randomization | Procedure or surgery | immediate angiography |
| early invasive angiographyearly invasive angiography 12-72 h after randomization | Procedure or surgery | early invasive angiography |
Primary outcome
Death and non-fatal recurrent infarction
Time frame: 6 months
1 secondary outcome
Composite of death, recurrent non-fatal myocardial infarction, refractory ischemia or target vessel re-vascularization
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Holger Thiele, MD study chair
Heart Center Leipzig - University Hospital
Uwe Zeymer, MD study director
Institut für Herzinfarktforschung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate angiography and revascularization and early invasive angiography in people with Non-ST-elevation Myocardial Infarction, run by University of Leipzig at 1 site in Germany.
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 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: withdrawn, as of the sponsor's last update on 6 Jul 2018. 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 Germany. 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.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Death and non-fatal recurrent infarction (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jul 2018.