Acute Myocardial InfarctionPhase 2NCT00260416
Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
A Phase 2 study testing Primary angioplasty with stent and abciximab in people with Acute Myocardial Infarction, run by Aarhus University Hospital Skejby at 1 site in Denmark.
Trial summary
Background: Acute balloon angioplasty is beneficial in patients with acute myocardial infarction. However, presently this treatment is not offered to patients with symptom duration above 12 hours. Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom duration above 12 hours. 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?
- Primary angioplasty with stent and abciximab
- Type of treatment
- Surgery or procedure
- How many people
- 60 participants
- Where
- 1 siteDenmark
- Study dates
- May 2005to Dec 2007
- Phase
- Phase 2
- 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
- Acute myocardial infarction with ST-segment elevation;
- Symptom duration 12 hours to 72 hours.
Who cannot join
- Age below 18 years;
- Bleeding disorders or anaemia or low levels of thrombocytes;
- Thrombolysis used during the present admission;
- Expected survival less than 1 year due to other diseases;
- Previous acute myocardial infarction or coronary by-pass surgery;
- Major operation within last 30 days;
- Heamorrhaghic stroke within last 3 months.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Departments of Cardiology and Nuclear Medicine at Skejby Hospital
Aarhus, DK-8200 N
About this study
Background: Acute balloon angioplasty is beneficial in patients with acute myocardial infarction. However, presently this treatment is not offered to patients with symptom duration above 12 hours.
Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom duration above 12 hours.
Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long symptom duration.
Read the detailed description
Methods: On arrival at our angioplasty laboratory, patients are informed about the study. If they accept to participate, we infuse 600 MBq of Sestamibi i.v. This binds in a first passage fashion without later redistribution to perfused myocardium. Non-perfused myocardium does not bind sestamibi. Primary angioplasty with stent and abciximab is then performed followed by myocardial scintigraphy to illustrate the non-perfused myocardial area that was at risk of infarction before the coronary artery was opened. Echocardiography is also performed. At 1 month, myocardial scintigraphy is repeated to evaluate infarct size. The difference between the myocardial area at risk of infarction before angioplasty and the myocardial infarct size 1 month later is defined as "salvage". Scintigraphy is repeated at 6 month and echocardiography is also repeated at 1 month and 6 months. The primary endpoint is "salvage". Accordingly, the aim is to demonstrate that salvage can be achieved with primary angioplasty for acute myocardial infarction despite symptom duration above 12 hours. Clinical endpoints are death and reinfarction. The results are compared with results in 200 patients with symptom duration below 12 hours. These patients are treated and examined according to the exact same protocol. By this comparison, it can be evaluated whether it is relevant that the current guidelines recommend acute balloon angioplasty only to patients with less than 12 hours of symptom duration.
- Conditions
- Acute Myocardial Infarction
- Being tested
- Primary angioplasty with stent and abciximab
- Keywords
- Acute myocardial infarction, Symptom duration, Primary angioplasty, Infarct size, Myocardial scintigraphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary angioplasty with stent and abciximabProcedure or surgery
What is being measured
The primary outcome is the main question the study is designed to answer.
Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).
Secondary outcomes (6)
Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
Death at 1 month and 6 months.
Reinfarction at 1 month and 6 months.
Ejection fraction at 1 day, 1 month and 6 months.
Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
Brain Natriuretic Peptide levels at 1 day, 1 month and 6 months.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2005 (estimated)
- Study startMay 2005
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aarhus University Hospital Skejby
- Sponsor type
- University, hospital or other
- Collaborators
- Danish Heart Foundation
- Investigators
- Steen D. Kristensen, MD, Study director, Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00260416
- Sponsor's protocol ID
- STEMI-12
- Status last verified
- May 2008
- First submitted
- 30 Nov 2005
- Last updated
- 22 May 2008
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Primary Angioplasty for Acute Myocardial Infarction in Patients With Symptom Duration Above 12 Hours
- ClinicalTrials.gov ID
- NCT00260416
- Acronym / sponsor ID
- STEMI-12
- Conditions
- Acute Myocardial Infarction
- Keywords
- Acute myocardial infarction, Symptom duration, Primary angioplasty, Infarct size, Myocardial scintigraphy
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Aarhus University Hospital SkejbyUniversity, hospital or other
- Collaborators
- Danish Heart Foundation
- Study start
- May 2005
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 1 Dec 2005 (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.
Background: Acute balloon angioplasty is beneficial in patients with acute myocardial infarction. However, presently this treatment is not offered to patients with symptom duration above 12 hours.
Hypothesis: Acute balloon angioplasty for myocardial infarction is beneficial despite symptom duration above 12 hours.
Methods: In 60 patients with myocardial infarction and symptom duration above 12 hours, the proportion of non-perfused myocardium before acute angioplasty and 1 month after angioplasty is compared to evaluate if myocardial tissue can be saved by acute angioplasty despite long symptom duration.
Detailed description
Methods: On arrival at our angioplasty laboratory, patients are informed about the study. If they accept to participate, we infuse 600 MBq of Sestamibi i.v. This binds in a first passage fashion without later redistribution to perfused myocardium. Non-perfused myocardium does not bind sestamibi. Primary angioplasty with stent and abciximab is then performed followed by myocardial scintigraphy to illustrate the non-perfused myocardial area that was at risk of infarction before the coronary artery was opened. Echocardiography is also performed. At 1 month, myocardial scintigraphy is repeated to evaluate infarct size. The difference between the myocardial area at risk of infarction before angioplasty and the myocardial infarct size 1 month later is defined as "salvage". Scintigraphy is repeated at 6 month and echocardiography is also repeated at 1 month and 6 months. The primary endpoint is "salvage". Accordingly, the aim is to demonstrate that salvage can be achieved with primary angioplasty for acute myocardial infarction despite symptom duration above 12 hours. Clinical endpoints are death and reinfarction. The results are compared with results in 200 patients with symptom duration below 12 hours. These patients are treated and examined according to the exact same protocol. By this comparison, it can be evaluated whether it is relevant that the current guidelines recommend acute balloon angioplasty only to patients with less than 12 hours of symptom duration.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Acute myocardial infarction with ST-segment elevation;
- Symptom duration 12 hours to 72 hours.
Key exclusion criteria (7 listed)
- Age below 18 years;
- Bleeding disorders or anaemia or low levels of thrombocytes;
- Thrombolysis used during the present admission;
- Expected survival less than 1 year due to other diseases;
- Previous acute myocardial infarction or coronary by-pass 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 |
|---|---|---|
| Primary angioplasty with stent and abciximab | Procedure or surgery | – |
Primary outcome
Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).
6 secondary outcomes
Infarct size by myocardial scintigraphy at 1 month and 6 months after primary angioplasty.
Death at 1 month and 6 months.
Reinfarction at 1 month and 6 months.
Ejection fraction at 1 day, 1 month and 6 months.
Left ventricular end diastolic volume at 1 day, 1 month and 6 months.
Brain Natriuretic Peptide levels at 1 day, 1 month and 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 22 May 2008.
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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.
Steen D. Kristensen, MD study director
Dept. of Cardiology, Skejby Hospital, AarhusUniversity Hospital, DK-8200 Aarhus N, Denmark, Europe
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Primary angioplasty with stent and abciximab in people with Acute Myocardial Infarction, run by Aarhus University Hospital Skejby at 1 site in Denmark.
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 2 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 22 May 2008. 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 Denmark. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Myocardial salvage as evaluated by repeat myocardial scintigraphy(= area at risk of infarction before primary angioplasty - infarct size at 1 month).. 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 22 May 2008; AzTrials last refreshed its copy on 8 Nov 2026.