ST-elevation Myocardial InfarctionPhase 3AIDA STEMINCT00712101
Abciximab i.v. Versus i.c. in ST-elevation Myocardial Infarction
A Phase 3 study testing abciximab intracoronary and abciximab intravenously in people with ST-elevation Myocardial Infarction, run by University of Leipzig at 11 sites in Germany.
Trial summary
The purpose of this study is to examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- ST-elevation Myocardial Infarction
- What is being tested?
- abciximab intracoronary and abciximab intravenously
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,912 participants
- Where
- 11 sitesGermany
- Study dates
- Jul 2008to Apr 2011
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Clinical symptoms:
- Angina pectoris < 12 hours and
- Persistent angina > 30 minutes
- ECG-criteria for ST-elevation myocardial infarction in 12-lead ECG:
- ST-segment elevation > 1mm in ≥ 2 extremity leads and/or
- ST-segment elevation > 2mm in ≥ 2 adjacent precordial leads
- Informed consent
Who cannot join
- No informed consent
- Pregnancy
- Known allergy to abciximab, ASA or heparin
- Active peptic ulcus ventriculi or duodeni
- Active, non-superficial bleeding
- History of major surgery (including intracranial or intraspinal) <4 weeks
Show all 15Show fewer
- active internal bleeding
- Cerebrovascular complications < 2 years
- Known coagulation defect or thrombocytopenia
- Arteriovenous malformations or aneurysm
- Severe liver insufficiency, renal insufficiency requiring dialysis
- Uncontrolled hypertension, hypertensive retinopathy
- Vaskulitis
- Thrombolysis < 12 h
- Participation in another trial
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Germany11 sites
Zentralklinik Bad Berka
Bad Berka, 99437
Herz- und Gefäß-KLinik Bad Neustadt
Bad Neustadt an der Saale, 97616
Herz und Diabeteszentrum Bad Oeynhausen
Bad Oeynhausen, 32545
Klinikum Links der Weser - Bremen
Bremen, 28277
Klinikum Coburg
Coburg, 96450
University of Leipzig - Heart Center
Leipzig, 04289
Carl-von-Basedow-Klinikum Merseburg
Merseburg, 06217
Klinikum Pirna
Pirna, 01796
Krankenhaus der Barmherzigen Brüder
Regensburg, 93049
Jochen Wöhrle
Ulm, 89081
Klinikum der Stadt Villingen-Schwenningen
Villingen-Schwenningen, 78045
About this study
Official title: Prospective Randomized Controlled Clinical Study to Compare Abciximab-bolus i.v. Versus i.c. in Primary PCI in Patients With Acute ST-elevation Myocardial Infarction
The purpose of this study is to examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure.
Read the detailed description
In patients with acute ST-elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI) is the preferred reperfusion regimen, if performed by experienced operators in a timely manner. Nevertheless, myocardial damage is not immediately terminated after successful epicardial reperfusion by primary PCI. Current strategies are directed to improve myocardial tissue perfusion, which is impaired in approximately 50% of patients and which has prognostic impact. Adjunctive intravenous abciximab administration is an established therapy to improve coronary microcirculation and reduce major cardiac adverse events.5-10 In randomized clinical trials intravenous abciximab administration has been studied. Clinical trials have shown that earlier administration results in higher preinterventional TIMI-flow with subsequent improved perfusion post PCI. However, in a pooled analysis there was no effect on mortality. As door-to-balloon-times getting shorter in current trials, earlier abciximab administration requires treatment in the prehospital setting, which poses substantial logistic obstacles. Another option might be intracoronary abciximab bolus administration which results in very high local platelet inhibitor concentrations. This might be favorable in dissolution of thrombi and microemboli with subsequent improved myocardial microcirculation, reduction of no-reflow, and infarct size. Currently, there is only limited clinical experience on the efficacy of intracoronary abciximab administration mainly restricted to case reports, retrospective registries or small randomized trials. In a recently published randomized clinical trial, we were able to show that intracoronary versus intravenous abciximab bolus administration has beneficial effects on the occurrence of no-reflow and infarct size assessed by contrast-enhancement magnetic resonance imaging. This led to a trend towards improved clinical outcome. The composite major adverse cardiac event rate, defined as death, reinfarction, target vessel revascularization, and new congestive heart failure, at 30 day follow-up was 15.6% after intravenous and 5.2% after intracoronary abciximab administration (relative risk 3.00; 95% confidence intervals 0.94-10.80; p=0.06).
Currently, there is no adequately powered clinical trial to assess the effects of intracoronary bolus in comparison to standard intravenous abciximab administration. Due to its general availability and its ease of intracoronary administration this treatment has overwhelming potential in clinical practice, which is much easier to achieve than a logistically cumbersome prehospital or interhospital transfer administration.
In the era of evidence-based medicine, such a trial is of paramount importance to achieve a break-through in abciximab use and a reduction of the high associated morbidity and mortality of STEMI patients.
- Conditions
- ST-elevation Myocardial Infarction
- Being tested
- abciximab intracoronary, abciximab intravenously
- Keywords
- infarction, intervention, stent, abciximab, platelets
- Medical subject headings
- ST Elevation Myocardial Infarction, Infarction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
abciximab intracoronaryDrug
administer abciximab bolus intracoronary during primary percutaneous coronary intervention
abciximab intravenouslyDrug
administer abciximab bolus intravenously during primary percutaneous coronary intervention
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Abciximab bolus administration intracoronary Receives: Drug: abciximab intracoronary |
| 2 | Active comparator | Abciximab bolus intravenously Receives: Drug: abciximab intravenously |
What is being measured
The primary outcome is the main question the study is designed to answer.
Combined clinical endpoint: death, reinfarction, new congestive heart failure
Measured: 90 days
Secondary outcomes (1)
ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionApr 2011
- Study completionApr 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (27)Papers the sponsor has linked to this study.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,912 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Leipzig
- Sponsor type
- University, hospital or other
- Investigators
- Holger Thiele, MD, PhD, Study chair, Heart Center Leipzig - University HospitalGerhard Schuler, MD, PhD, Study director, Heart Center Leipzig - University HospitalJochen Woehrle, MD, PhD, Principal investigator, University of Ulm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00712101
- Sponsor's protocol ID
- Final version 1.1
- Acronym
- AIDA STEMI
- Status last verified
- Aug 2009
- First submitted
- 3 Jul 2008
- Last updated
- 20 Apr 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.
PubMed 18559698Lange T, Backhaus SJ, Schulz A, Evertz R, Kowallick JT, Bigalke B, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Cardiovascular magnetic resonance-derived left atrioventricular coupling index and major adverse cardiac events in patients following acute myocardial infarction. J Cardiovasc Magn Reson. 2023 Apr 13;25(1):24. doi: 10.1186/s12968-023-00929-w.
PubMed 37046343Backhaus SJ, Rosel SF, Stiermaier T, Schmidt-Rimpler J, Evertz R, Schulz A, Lange T, Kowallick JT, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I, Schuster A. Left-atrial long-axis shortening allows effective quantification of atrial function and optimized risk prediction following acute myocardial infarction. Eur Heart J Open. 2022 Aug 12;2(5):oeac053. doi: 10.1093/ehjopen/oeac053. eCollection 2022 Sep.
PubMed 36268539Backhaus SJ, Aldehayat H, Kowallick JT, Evertz R, Lange T, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Artificial intelligence fully automated myocardial strain quantification for risk stratification following acute myocardial infarction. Sci Rep. 2022 Jul 18;12(1):12220. doi: 10.1038/s41598-022-16228-w.
PubMed 35851282Jensch PJ, Stiermaier T, Reinstadler SJ, Feistritzer HJ, Desch S, Fuernau G, de Waha-Thiele S, Thiele H, Eitel I. Prognostic relevance of peri-infarct zone measured by cardiovascular magnetic resonance in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2022 Jan 15;347:83-88. doi: 10.1016/j.ijcard.2021.11.017. Epub 2021 Nov 10.
PubMed 34767896Lange T, Stiermaier T, Backhaus SJ, Boom PC, Kowallick JT, de Waha-Thiele S, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Desch S, Hasenfuss G, Thiele H, Eitel I, Schuster A. Functional and prognostic implications of cardiac magnetic resonance feature tracking-derived remote myocardial strain analyses in patients following acute myocardial infarction. Clin Res Cardiol. 2021 Feb;110(2):270-280. doi: 10.1007/s00392-020-01747-1. Epub 2020 Oct 20.
PubMed 33083869Schuster A, Lange T, Backhaus SJ, Strohmeyer C, Boom PC, Matz J, Kowallick JT, Lotz J, Steinmetz M, Kutty S, Bigalke B, Gutberlet M, de Waha-Thiele S, Desch S, Hasenfuss G, Thiele H, Stiermaier T, Eitel I. Fully Automated Cardiac Assessment for Diagnostic and Prognostic Stratification Following Myocardial Infarction. J Am Heart Assoc. 2020 Sep 15;9(18):e016612. doi: 10.1161/JAHA.120.016612. Epub 2020 Sep 2.
PubMed 32873121Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Navarra JL, Koschalka A, Evertz R, Lotz J, Kutty S, Hasenfuss G, Gutberlet M, Thiele H, Eitel I, Schuster A. Cardiac Magnetic Resonance Myocardial Feature Tracking for Optimized Risk Assessment After Acute Myocardial Infarction in Patients With Type 2 Diabetes. Diabetes. 2020 Jul;69(7):1540-1548. doi: 10.2337/db20-0001. Epub 2020 Apr 24.
PubMed 32335515Schuster A, Backhaus SJ, Stiermaier T, Kowallick JT, Stulle A, Koschalka A, Lotz J, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I. Fast manual long-axis strain assessment provides optimized cardiovascular event prediction following myocardial infarction. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1262-1270. doi: 10.1093/ehjci/jez077.
PubMed 31329854Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Koschalka A, Navarra JL, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Hasenfuss G, Thiele H, Schuster A, Eitel I. Culprit vessel-related myocardial mechanics and prognostic implications following acute myocardial infarction. Clin Res Cardiol. 2020 Mar;109(3):339-349. doi: 10.1007/s00392-019-01514-x. Epub 2019 Jul 5.
PubMed 31278521Reinstadler SJ, Stiermaier T, Eitel C, Fuernau G, Saad M, Poss J, de Waha S, Mende M, Desch S, Metzler B, Thiele H, Eitel I. Impact of Atrial Fibrillation During ST-Segment-Elevation Myocardial Infarction on Infarct Characteristics and Prognosis. Circ Cardiovasc Imaging. 2018 Feb;11(2):e006955. doi: 10.1161/CIRCIMAGING.117.006955.
PubMed 29391346Stiermaier T, Jobs A, de Waha S, Fuernau G, Poss J, Desch S, Thiele H, Eitel I. Optimized Prognosis Assessment in ST-Segment-Elevation Myocardial Infarction Using a Cardiac Magnetic Resonance Imaging Risk Score. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006774. doi: 10.1161/CIRCIMAGING.117.006774.
PubMed 29122844Reinstadler SJ, Stiermaier T, Eitel C, Metzler B, de Waha S, Fuernau G, Desch S, Thiele H, Eitel I. Relationship between diabetes and ischaemic injury among patients with revascularized ST-elevation myocardial infarction. Diabetes Obes Metab. 2017 Dec;19(12):1706-1713. doi: 10.1111/dom.13002. Epub 2017 Jul 25.
PubMed 28474817Reinstadler SJ, Stiermaier T, Eitel C, Saad M, Metzler B, de Waha S, Fuernau G, Desch S, Thiele H, Eitel I. Antecedent hypertension and myocardial injury in patients with reperfused ST-elevation myocardial infarction. J Cardiovasc Magn Reson. 2016 Nov 11;18(1):80. doi: 10.1186/s12968-016-0299-1.
PubMed 27832796de Waha S, Eitel I, Desch S, Fuernau G, Poss J, Schuler G, Thiele H. Impact of multivessel coronary artery disease on reperfusion success in patients with ST-elevation myocardial infarction: A substudy of the AIDA STEMI trial. Eur Heart J Acute Cardiovasc Care. 2017 Oct;6(7):592-600. doi: 10.1177/2048872615624240. Epub 2015 Dec 21.
PubMed 26691729
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Randomized Controlled Clinical Study to Compare Abciximab-bolus i.v. Versus i.c. in Primary PCI in Patients With Acute ST-elevation Myocardial Infarction
- ClinicalTrials.gov ID
- NCT00712101
- Acronym / sponsor ID
- AIDA STEMI / Final version 1.1
- Conditions
- ST-elevation Myocardial Infarction
- Keywords
- infarction, intervention, stent, abciximab, platelets
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,912 participants (estimated)
- Lead sponsor
- University of LeipzigUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Apr 2011 (actual)
- Study completion
- Apr 2011 (actual)
- First posted
- 9 Jul 2008 (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 purpose of this study is to examine whether intracoronary abciximab bolus application with subsequent 12 hour intravenous infusion in addition to primary percutaneous coronary intervention is beneficial for patients with STEMI in comparison to standard i.v. bolus application with respect to 90-day mortality, reinfarction and new congestive heart failure.
Detailed description
In patients with acute ST-elevation myocardial infarction (STEMI) primary percutaneous coronary intervention (PCI) is the preferred reperfusion regimen, if performed by experienced operators in a timely manner. Nevertheless, myocardial damage is not immediately terminated after successful epicardial reperfusion by primary PCI. Current strategies are directed to improve myocardial tissue perfusion, which is impaired in approximately 50% of patients and which has prognostic impact. Adjunctive intravenous abciximab administration is an established therapy to improve coronary microcirculation and reduce major cardiac adverse events.5-10 In randomized clinical trials intravenous abciximab administration has been studied. Clinical trials have shown that earlier administration results in higher preinterventional TIMI-flow with subsequent improved perfusion post PCI. However, in a pooled analysis there was no effect on mortality. As door-to-balloon-times getting shorter in current trials, earlier abciximab administration requires treatment in the prehospital setting, which poses substantial logistic obstacles. Another option might be intracoronary abciximab bolus administration which results in very high local platelet inhibitor concentrations. This might be favorable in dissolution of thrombi and microemboli with subsequent improved myocardial microcirculation, reduction of no-reflow, and infarct size. Currently, there is only limited clinical experience on the efficacy of intracoronary abciximab administration mainly restricted to case reports, retrospective registries or small randomized trials. In a recently published randomized clinical trial, we were able to show that intracoronary versus intravenous abciximab bolus administration has beneficial effects on the occurrence of no-reflow and infarct size assessed by contrast-enhancement magnetic resonance imaging. This led to a trend towards improved clinical outcome. The composite major adverse cardiac event rate, defined as death, reinfarction, target vessel revascularization, and new congestive heart failure, at 30 day follow-up was 15.6% after intravenous and 5.2% after intracoronary abciximab administration (relative risk 3.00; 95% confidence intervals 0.94-10.80; p=0.06).
Currently, there is no adequately powered clinical trial to assess the effects of intracoronary bolus in comparison to standard intravenous abciximab administration. Due to its general availability and its ease of intracoronary administration this treatment has overwhelming potential in clinical practice, which is much easier to achieve than a logistically cumbersome prehospital or interhospital transfer administration.
In the era of evidence-based medicine, such a trial is of paramount importance to achieve a break-through in abciximab use and a reduction of the high associated morbidity and mortality of STEMI patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: abciximab intracoronaryAbciximab bolus administration intracoronary |
| 2 | Active comparator | Drug: abciximab intravenouslyAbciximab bolus intravenously |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Clinical symptoms:
- ECG-criteria for ST-elevation myocardial infarction in 12-lead ECG:
- Informed consent
Key exclusion criteria (15 listed)
- No informed consent
- Pregnancy
- Known allergy to abciximab, ASA or heparin
- Active peptic ulcus ventriculi or duodeni
- Active, non-superficial bleeding
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 |
|---|---|---|
| abciximab intracoronaryadminister abciximab bolus intracoronary during primary percutaneous coronary intervention | Drug | 1 |
| abciximab intravenouslyadminister abciximab bolus intravenously during primary percutaneous coronary intervention | Drug | 2 |
Primary outcome
Combined clinical endpoint: death, reinfarction, new congestive heart failure
Time frame: 90 days
1 secondary outcome
ST-segment resolution 90 minute ECG TIMI-flow post PCI indirect infarct size by enzyme release individual clinical endpoints
Time frame: 90 days
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 20 Apr 2011.
- Background: PubMed 18559698Thiele H, Schindler K, Friedenberger J, Eitel I, Furnau G, Grebe E, Erbs S, Linke A, Mobius-Winkler S, Kivelitz D, Schuler G. Intracoronary compared with intravenous bolus abciximab application in patients with ST-elevation myocardial infarction undergoing primary percutaneous coronary intervention: the randomized Leipzig immediate percutaneous coronary intervention abciximab IV versus IC in ST-elevation myocardial infarction trial. Circulation. 2008 Jul 1;118(1):49-57. doi: 10.1161/CIRCULATIONAHA.107.747642. Epub 2008 Jun 16.
- Derived from this study: PubMed 37046343Lange T, Backhaus SJ, Schulz A, Evertz R, Kowallick JT, Bigalke B, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Cardiovascular magnetic resonance-derived left atrioventricular coupling index and major adverse cardiac events in patients following acute myocardial infarction. J Cardiovasc Magn Reson. 2023 Apr 13;25(1):24. doi: 10.1186/s12968-023-00929-w.
- Derived from this study: PubMed 36268539Backhaus SJ, Rosel SF, Stiermaier T, Schmidt-Rimpler J, Evertz R, Schulz A, Lange T, Kowallick JT, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I, Schuster A. Left-atrial long-axis shortening allows effective quantification of atrial function and optimized risk prediction following acute myocardial infarction. Eur Heart J Open. 2022 Aug 12;2(5):oeac053. doi: 10.1093/ehjopen/oeac053. eCollection 2022 Sep.
- Derived from this study: PubMed 35851282Backhaus SJ, Aldehayat H, Kowallick JT, Evertz R, Lange T, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Stiermaier T, Eitel I, Schuster A. Artificial intelligence fully automated myocardial strain quantification for risk stratification following acute myocardial infarction. Sci Rep. 2022 Jul 18;12(1):12220. doi: 10.1038/s41598-022-16228-w.
- Derived from this study: PubMed 34767896Jensch PJ, Stiermaier T, Reinstadler SJ, Feistritzer HJ, Desch S, Fuernau G, de Waha-Thiele S, Thiele H, Eitel I. Prognostic relevance of peri-infarct zone measured by cardiovascular magnetic resonance in patients with ST-segment elevation myocardial infarction. Int J Cardiol. 2022 Jan 15;347:83-88. doi: 10.1016/j.ijcard.2021.11.017. Epub 2021 Nov 10.
- Derived from this study: PubMed 33083869Lange T, Stiermaier T, Backhaus SJ, Boom PC, Kowallick JT, de Waha-Thiele S, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Desch S, Hasenfuss G, Thiele H, Eitel I, Schuster A. Functional and prognostic implications of cardiac magnetic resonance feature tracking-derived remote myocardial strain analyses in patients following acute myocardial infarction. Clin Res Cardiol. 2021 Feb;110(2):270-280. doi: 10.1007/s00392-020-01747-1. Epub 2020 Oct 20.
- Derived from this study: PubMed 32873121Schuster A, Lange T, Backhaus SJ, Strohmeyer C, Boom PC, Matz J, Kowallick JT, Lotz J, Steinmetz M, Kutty S, Bigalke B, Gutberlet M, de Waha-Thiele S, Desch S, Hasenfuss G, Thiele H, Stiermaier T, Eitel I. Fully Automated Cardiac Assessment for Diagnostic and Prognostic Stratification Following Myocardial Infarction. J Am Heart Assoc. 2020 Sep 15;9(18):e016612. doi: 10.1161/JAHA.120.016612. Epub 2020 Sep 2.
- Derived from this study: PubMed 32335515Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Navarra JL, Koschalka A, Evertz R, Lotz J, Kutty S, Hasenfuss G, Gutberlet M, Thiele H, Eitel I, Schuster A. Cardiac Magnetic Resonance Myocardial Feature Tracking for Optimized Risk Assessment After Acute Myocardial Infarction in Patients With Type 2 Diabetes. Diabetes. 2020 Jul;69(7):1540-1548. doi: 10.2337/db20-0001. Epub 2020 Apr 24.
- Derived from this study: PubMed 31329854Schuster A, Backhaus SJ, Stiermaier T, Kowallick JT, Stulle A, Koschalka A, Lotz J, Kutty S, Bigalke B, Gutberlet M, Hasenfuss G, Thiele H, Eitel I. Fast manual long-axis strain assessment provides optimized cardiovascular event prediction following myocardial infarction. Eur Heart J Cardiovasc Imaging. 2019 Nov 1;20(11):1262-1270. doi: 10.1093/ehjci/jez077.
- Derived from this study: PubMed 31278521Backhaus SJ, Kowallick JT, Stiermaier T, Lange T, Koschalka A, Navarra JL, Lotz J, Kutty S, Bigalke B, Gutberlet M, Feistritzer HJ, Hasenfuss G, Thiele H, Schuster A, Eitel I. Culprit vessel-related myocardial mechanics and prognostic implications following acute myocardial infarction. Clin Res Cardiol. 2020 Mar;109(3):339-349. doi: 10.1007/s00392-019-01514-x. Epub 2019 Jul 5.
- Derived from this study: PubMed 29391346Reinstadler SJ, Stiermaier T, Eitel C, Fuernau G, Saad M, Poss J, de Waha S, Mende M, Desch S, Metzler B, Thiele H, Eitel I. Impact of Atrial Fibrillation During ST-Segment-Elevation Myocardial Infarction on Infarct Characteristics and Prognosis. Circ Cardiovasc Imaging. 2018 Feb;11(2):e006955. doi: 10.1161/CIRCIMAGING.117.006955.
- Derived from this study: PubMed 29122844Stiermaier T, Jobs A, de Waha S, Fuernau G, Poss J, Desch S, Thiele H, Eitel I. Optimized Prognosis Assessment in ST-Segment-Elevation Myocardial Infarction Using a Cardiac Magnetic Resonance Imaging Risk Score. Circ Cardiovasc Imaging. 2017 Nov;10(11):e006774. doi: 10.1161/CIRCIMAGING.117.006774.
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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, PhD study chair
Heart Center Leipzig - University Hospital
Gerhard Schuler, MD, PhD study director
Heart Center Leipzig - University Hospital
Jochen Woehrle, MD, PhD principal investigator
University of Ulm
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing abciximab intracoronary and abciximab intravenously in people with ST-elevation Myocardial Infarction, run by University of Leipzig at 11 sites 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 7 inclusion and 15 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 20 Apr 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites 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.
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?
Combined clinical endpoint: death, reinfarction, new congestive heart failure (time frame: 90 days). 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 NCT00712101, which also lists 27 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 20 Apr 2011.