Acute Myocardial InfarctionPhase 4SIAMIIINCT01124890
Southwest German Interventional Study in Acute Myocardial Infarction III
A Phase 4 study testing early percutaneous coronary intervention and late percutaneous coronary intervention in people with Acute Myocardial Infarction, run by University Hospital, Saarland at 1 site in Germany.
Trial summary
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Myocardial Infarction
- What is being tested?
- early percutaneous coronary intervention and late percutaneous coronary intervention
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 197 participants
- Where
- 1 siteGermany
- Study dates
- Jul 1998to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms of MI present for 12 h
- ST segment elevation of at least 1 mm in two or more limb leads,
- ST segment elevation of at least 2 mm in the precordial leads,
- or new bundlebranch block
- Patients eligible for thrombolysis
- Informed consent for participation
Who cannot join
- Secondary or iatrogenic infarction
- Chronic renal insufficiency requiring dialysis
- Coronary anatomy unsuitable for stent placement
- Anticipated indication for surgical coronary revascularization within 6 months
- Previous MI in the area of the infarct related vessel
- Infarct related lesion not clearly defined
Trial locations and contacts
1 site in 1 country.
Germany1 site
University Hospital, Klinik fuer Innere Medizin III
Homburg/Saar, 66421
About this study
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis.
Read the detailed description
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. All patients received reteplase, aspirin in combination with ticlopidin, and heparin. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis. In total 197 patients were included, 163 were treated by PCI. The primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.
- Conditions
- Acute Myocardial Infarction
- Being tested
- early percutaneous coronary intervention, late percutaneous coronary intervention
- Keywords
- acute myocardial infarction, thrombolysis, percutaneous coronary interention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
early percutaneous coronary interventionDevice
late percutaneous coronary interventionDevice
| Study group | Role | What they receive |
|---|---|---|
| Conservative | Placebo comparator | no transfer for early percutaneous coronary intervention after thrombolysis Receives: Device: late percutaneous coronary intervention |
| early PCI | Active comparator | transfer for early percutaneous coronary intervention after thrombolysis Receives: Device: early percutaneous coronary intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Adverse Cardiovascular Events
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
Measured: 6 months
Secondary outcomes (4)
Death
Total mortality as well as cardiac and noncardiac deaths were counted.
Measured: 6 months
Reinfarction
Reinfarction was defined as two or more of the following criteria: chest pain lasting for more than 30 minutes; a new significant ST-elevation; and a rise in the serum creatine kinase level to more than >3x upper normal limit.
Measured: 6 months
Ischemic Events
Ischemic events included unplanned hospitalization and / or unplanned angiography due to postinfarction angina, recurrent angina pectoris lasting for more than 15 minutes despite the administration of nitrates, or being accompanied by electrocardiogram changes, pulmonary edema, or hypotension.
Measured: 6 months
Target Vessel Revascularization
Target vessel revascularization was defined as any repeated percutaneous coronary intervention or coronary artery bypass graft surgery involving the infarct related lesion.
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 posted17 May 2010 (estimated)
- Study startJul 1998
- Primary completionOct 2001
- Study completionOct 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 197 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Saarland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Bruno Scheller, MD, Principal investigator, University of Saarland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01124890
- Sponsor's protocol ID
- BS S3
- Acronym
- SIAMIII
- Status last verified
- Apr 2023
- First submitted
- 11 May 2010
- Last updated
- 27 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Scheller B, Hennen B, Hammer B, Walle J, Hofer C, Hilpert V, Winter H, Nickenig G, Bohm M; SIAM III Study Group. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. J Am Coll Cardiol. 2003 Aug 20;42(4):634-41. doi: 10.1016/s0735-1097(03)00763-0.
PubMed 12932593Clever YP, Cremers B, Link A, Bohm M, Scheller B. Long-term follow-up of early versus delayed invasive approach after fibrinolysis in acute myocardial infarction. Circ Cardiovasc Interv. 2011 Aug;4(4):342-8. doi: 10.1161/CIRCINTERVENTIONS.111.962316. Epub 2011 Jun 28.
PubMed 21712524
Study at a glance
From the registry record, last updated by the sponsor on 27 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Southwest German Interventional Study in Acute Myocardial Infarction III
- ClinicalTrials.gov ID
- NCT01124890
- Acronym / sponsor ID
- SIAMIII / BS S3
- Conditions
- Acute Myocardial Infarction
- Keywords
- acute myocardial infarction, thrombolysis, percutaneous coronary interention
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 197 participants (actual)
- Lead sponsor
- University Hospital, SaarlandUniversity, hospital or other
- Study start
- Jul 1998
- Primary completion
- Oct 2001 (actual)
- Study completion
- Oct 2009 (actual)
- First posted
- 17 May 2010 (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.
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis.
Detailed description
SIAM III was a multicenter, randomized, prospective, controlled trial in patients with ST-elevation myocardial infarction receiving fibrinolysis <12 hours after onset of symptoms. All patients received reteplase, aspirin in combination with ticlopidin, and heparin. Patients of the early PCI group were transferred within 6 hours after fibrinolysis for PCI. The conservative group received elective PCI two weeks after fibrinolysis. In total 197 patients were included, 163 were treated by PCI. The primary end point was the composite of ischemic events, death, reinfarction, and target lesion revascularization.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conservative | Placebo comparator | Device: late percutaneous coronary interventionno transfer for early percutaneous coronary intervention after thrombolysis |
| early PCI | Active comparator | Device: early percutaneous coronary interventiontransfer for early percutaneous coronary intervention after thrombolysis |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Symptoms of MI present for 12 h
- ST segment elevation of at least 1 mm in two or more limb leads,
- ST segment elevation of at least 2 mm in the precordial leads,
- or new bundlebranch block
- Patients eligible for thrombolysis
Key exclusion criteria (6 listed)
- Secondary or iatrogenic infarction
- Chronic renal insufficiency requiring dialysis
- Coronary anatomy unsuitable for stent placement
- Anticipated indication for surgical coronary revascularization within 6 months
- Previous MI in the area of the infarct related vessel
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 |
|---|---|---|
| early percutaneous coronary intervention | Device | early PCI |
| late percutaneous coronary intervention | Device | Conservative |
Primary outcome
Major Adverse Cardiovascular Events
Time frame: 6 months
The primary endpoint was a combined endpoint consisting of death, reinfarction, ischemic events, and target vessel revascularization.
4 secondary outcomes
Death
Time frame: 6 months
Reinfarction
Time frame: 6 months
Ischemic Events
Time frame: 6 months
Target Vessel Revascularization
Time frame: 6 months
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 Apr 2023.
- Results publication: PubMed 12932593Scheller B, Hennen B, Hammer B, Walle J, Hofer C, Hilpert V, Winter H, Nickenig G, Bohm M; SIAM III Study Group. Beneficial effects of immediate stenting after thrombolysis in acute myocardial infarction. J Am Coll Cardiol. 2003 Aug 20;42(4):634-41. doi: 10.1016/s0735-1097(03)00763-0.
- Derived from this study: PubMed 21712524Clever YP, Cremers B, Link A, Bohm M, Scheller B. Long-term follow-up of early versus delayed invasive approach after fibrinolysis in acute myocardial infarction. Circ Cardiovasc Interv. 2011 Aug;4(4):342-8. doi: 10.1161/CIRCINTERVENTIONS.111.962316. Epub 2011 Jun 28.
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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.
Bruno Scheller, MD principal investigator
University of Saarland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing early percutaneous coronary intervention and late percutaneous coronary intervention in people with Acute Myocardial Infarction, run by University Hospital, Saarland 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 6 inclusion and 6 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 Apr 2023. 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. 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 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?
Major Adverse Cardiovascular Events (time frame: 6 months). 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 NCT01124890, which also lists 2 linked publications.
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 Apr 2023.