Acute Coronary SyndromeAMIS PlusNCT01305785
AMIS Plus - National Registry of Acute Myocardial Infarction in Switzerland
An observational study of Acute Coronary Syndrome, run by Luzerner Kantonsspital at 1 site in Switzerland.
Trial summary
The AMIS Plus national registry collects and analyzes data on patients with acute myocardial infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and treatment of acute coronary syndrome. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acute Coronary Syndrome
- How many people
- 60,000 participants
- Where
- 1 siteSwitzerland
- Study dates
- Jan 1997to not given
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Acute myocardial infarction definition: 1. Characteristic ischemic symptoms 2. ECG changes indicating new ischemia (ST-T changes or new left bundle branch block) or developing pathological Q-waves 3. A dynamic increase or decrease in biomarker or troponin (I or T) levels above the individual hospital cut-off for MI. The internationally accepted guidelines for troponin levels are set at least one value above the 99th percentile of the upper reference limit (URL). Cut-off levels for either total creatine kinase (CK) or creatine kinase MB fraction (CK-MB) at least twice the upper limit of normal.
Inclusion Criteria: Patients who had symptoms within the last 48 hours at hospital admission with a discharge clinical diagnosis of acute myocardial infarction or patients who suffered an acute myocardial infarction in hospital during a hospitalization for other reasons.
Exclusion Criteria: Since January 2012, patients with unstable angina are no longer included.
Trial locations and contacts
1 site in 1 country.
Switzerland1 site, 1 recruiting
- Recruiting
University of Zurich
Zurich
Dragana Radovanovic
About this study
Official title: National Registry of Acute Myocardial Infarction in Switzerland
The AMIS Plus national registry collects and analyzes data on patients with acute myocardial infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and treatment of acute coronary syndrome. The AMIS Plus data gathered are important for assessing guidelines, improving compliance with guidelines in clinical practice, investigating patient groups not extensively studied in large randomized trials, quality assurance as well as the continuous improvement of therapeutic strategies based on a large database.
Read the detailed description
The AMIS Plus project has two main goals:
- To Maintain a Nationwide Registry
- An ongoing nationwide registry (databank) of acute coronary syndromes
- Description of the patient population with acute coronary syndromes
- Description of characteristics of treatment and hospitalization
- Description of outcomes 3- and 12-months after admission for ACS
- Epidemiological studies, e.g. definition of risk factors of patients with acute coronary syndromes, hospital mortality, time and cost-effective strategies as well as outcome measures
- Quality Control
- Evaluation of compliance with guidelines for the medical care of acute coronary syndromes
- Internal quality control through regular feedback and benchmarking
Methods
All Swiss hospitals admitting patients with acute coronary syndrome are eligible. Data are collected on demographics, risk factors, symptoms, laboratory results, invasive therapy, complications and medication.
Since the start in January 1997, the method of data collection has continuously improved in order to suit the different needs and technological advancements of the participating hospitals. Participants can either complete paper questionnaires and send them directly to the AMIS Plus Data Center at the Institute of Social and Preventive Medicine in Zurich where these questionnaires are then checked and entered online or they can enter data directly online (AMIS online questionnaire). Data security has a high priority. Participant identification (code for hospital and physician) and a password are required to access the data entry form and send data.
- Conditions
- Acute Coronary Syndrome
- Medical subject headings
- Acute Coronary Syndrome
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2011 (estimated)
- Study startJan 1997
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Acute Coronary SyndromeStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luzerner Kantonsspital
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zurich, University Hospital, Geneva, Insel Gruppe AG, University Hospital Bern, University Hospital, Basel, Switzerland, Triemli Hospital, Kantonsspital Baden, Cantonal Hospital of St. Gallen, University Hospital Freiburg, Cantonal Hospital, Frauenfeld, Hospital Centre Biel/Bienne, Spital Lachen AG, Cardiocentro Ticino
- Responsible party
- Principal investigator, Prof. Paul Erne, Luzerner Kantonsspital
- Investigators
- Paul Erne, MD, Study director, AMIS Plus Data Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01305785
- Sponsor's protocol ID
- AMIS Plus
- Acronym
- AMIS Plus
- Status last verified
- Apr 2013
- First submitted
- 28 Feb 2011
- Last updated
- 17 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Radovanovic D, Erne P. AMIS Plus: Swiss registry of acute coronary syndrome. Heart. 2010 Jun;96(12):917-21. doi: 10.1136/hrt.2009.192302.
PubMed 20538666Schoenenberger-Berzins R, Messerli FH, Schoenenberger AW, Foster-Witassek F, Rickli H, Pedrazzini G, Roffi M, Puhan M, Radovanovic D. Management of Acute Coronary Syndromes: Is the Yentl Syndrome Vanishing? J Am Heart Assoc. 2026 Aug 20:e049890. doi: 10.1161/JAHA.125.049890. Online ahead of print.
PubMed 42622111Roberto M, Hoepli A, Cattaneo M, Radovanovic D, Rickli H, Erne P, Pedrazzini GB, Moccetti M. Patients With AMI and Severely Reduced LVEF, a Well-Defined, Still Extremely Vulnerable Population (Insights from AMIS Plus Registry). Am J Cardiol. 2023 Aug 1;200:190-201. doi: 10.1016/j.amjcard.2023.05.027. Epub 2023 Jun 20.
PubMed 37348272Roberto M, Radovanovic D, Butta C, Tersalvi G, Krull J, Erne P, Rickli H, Pedrazzini GB, Moccetti M. Dual antiplatelet therapy is under-prescribed in patients with surgically treated acute myocardial infarction. Interact Cardiovasc Thorac Surg. 2021 Oct 29;33(5):687-694. doi: 10.1093/icvts/ivab159.
PubMed 34171919Bruggmann C, Iglesias JF, Gex-Fabry M, Fesselet R, Vogt P, Sadeghipour F, Voirol P. Long-Term Quality of Prescription for ST-Segment Elevation Myocardial Infarction (STEMI) Patients: A Real World 1-Year Follow-Up Study. Am J Cardiovasc Drugs. 2020 Feb;20(1):105-115. doi: 10.1007/s40256-019-00361-5.
PubMed 31300969Radovanovic D, Seifert B, Roffi M, Urban P, Rickli H, Pedrazzini G, Erne P. Gender differences in the decrease of in-hospital mortality in patients with acute myocardial infarction during the last 20 years in Switzerland. Open Heart. 2017 Nov 14;4(2):e000689. doi: 10.1136/openhrt-2017-000689. eCollection 2017.
PubMed 29177059Bertel N, Witassek F, Puhan M, Erne P, Rickli H, Naegeli B, Pedrazzini G, Stauffer JC, Radovanovic D. Management and outcome of patients with acute myocardial infarction presenting with pacemaker rhythm. Int J Cardiol. 2017 Mar 1;230:604-609. doi: 10.1016/j.ijcard.2016.12.047. Epub 2016 Dec 20.
PubMed 28040280Schoenenberger AW, Radovanovic D, Windecker S, Iglesias JF, Pedrazzini G, Stuck AE, Erne P; AMIS Plus Investigators. Temporal trends in the treatment and outcomes of elderly patients with acute coronary syndrome. Eur Heart J. 2016 Apr 21;37(16):1304-11. doi: 10.1093/eurheartj/ehv698. Epub 2016 Jan 12.
PubMed 26757786Erne P, Radovanovic D, Seifert B, Bertel O, Urban P; AMIS Plus Investigators. Outcome of patients admitted with acute coronary syndrome on palliative treatment: insights from the nationwide AMIS Plus Registry 1997-2014. BMJ Open. 2015 Mar 2;5(3):e006218. doi: 10.1136/bmjopen-2014-006218.
PubMed 25732032Wildi K, Cuculi F, Twerenbold R, Marxer T, Rubini Gimenez M, Reichlin T, Haaf P, Monsch R, Marsch S, Hunziker P, Bingisser R, Osswald S, Erne P, Mueller C. Incidence and timing of serious arrhythmias after early revascularization in non ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2015 Aug;4(4):359-64. doi: 10.1177/2048872614557230. Epub 2014 Oct 27.
PubMed 25348273Radovanovic D, Seifert B, Urban P, Eberli FR, Rickli H, Bertel O, Puhan MA, Erne P; AMIS Plus Investigators. Validity of Charlson Comorbidity Index in patients hospitalised with acute coronary syndrome. Insights from the nationwide AMIS Plus registry 2002-2012. Heart. 2014 Feb;100(4):288-94. doi: 10.1136/heartjnl-2013-304588. Epub 2013 Nov 1.
PubMed 24186563
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- National Registry of Acute Myocardial Infarction in Switzerland
- ClinicalTrials.gov ID
- NCT01305785
- Acronym / sponsor ID
- AMIS Plus / AMIS Plus
- Conditions
- Acute Coronary Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60,000 participants (estimated)
- Lead sponsor
- Luzerner KantonsspitalUniversity, hospital or other
- Collaborators
- University of Zurich, University Hospital, Geneva, Insel Gruppe AG, University Hospital Bern, University Hospital, Basel, Switzerland, Triemli Hospital, Kantonsspital Baden, Cantonal Hospital of St. Gallen, University Hospital Freiburg, Cantonal Hospital, Frauenfeld, Hospital Centre Biel/Bienne, Spital Lachen AG, Cardiocentro Ticino
- Study start
- Jan 1997
- First posted
- 1 Mar 2011 (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 AMIS Plus national registry collects and analyzes data on patients with acute myocardial infarction in Switzerland in the pre-admission, hospital and follow-up phases. Emphasis is placed on the evaluation of risk factors, diagnostics, urgent therapy strategies and treatment of acute coronary syndrome. The AMIS Plus data gathered are important for assessing guidelines, improving compliance with guidelines in clinical practice, investigating patient groups not extensively studied in large randomized trials, quality assurance as well as the continuous improvement of therapeutic strategies based on a large database.
Detailed description
The AMIS Plus project has two main goals:
- To Maintain a Nationwide Registry
- An ongoing nationwide registry (databank) of acute coronary syndromes
- Description of the patient population with acute coronary syndromes
- Description of characteristics of treatment and hospitalization
- Description of outcomes 3- and 12-months after admission for ACS
- Epidemiological studies, e.g. definition of risk factors of patients with acute coronary syndromes, hospital mortality, time and cost-effective strategies as well as outcome measures
- Quality Control
- Evaluation of compliance with guidelines for the medical care of acute coronary syndromes
- Internal quality control through regular feedback and benchmarking
Methods
All Swiss hospitals admitting patients with acute coronary syndrome are eligible. Data are collected on demographics, risk factors, symptoms, laboratory results, invasive therapy, complications and medication.
Since the start in January 1997, the method of data collection has continuously improved in order to suit the different needs and technological advancements of the participating hospitals. Participants can either complete paper questionnaires and send them directly to the AMIS Plus Data Center at the Institute of Social and Preventive Medicine in Zurich where these questionnaires are then checked and entered online or they can enter data directly online (AMIS online questionnaire). Data security has a high priority. Participant identification (code for hospital and physician) and a password are required to access the data entry form and send data.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Acute myocardial infarction definition: 1. Characteristic ischemic symptoms 2. ECG changes indicating new ischemia (ST-T changes or new left bundle branch block) or developing pathological Q-waves 3. A dynamic increase or decrease in biomarker or troponin (I or T) levels above the individual hospital cut-off for MI. The internationally accepted guidelines for troponin levels are set at least one value above the 99th percentile of the upper reference limit (URL). Cut-off levels for either total creatine kinase (CK) or creatine kinase MB fraction (CK-MB) at least twice the upper limit of normal.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Not reported in the source record.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2013.
- Results publication: PubMed 20538666Radovanovic D, Erne P. AMIS Plus: Swiss registry of acute coronary syndrome. Heart. 2010 Jun;96(12):917-21. doi: 10.1136/hrt.2009.192302.
- Derived from this study: PubMed 42622111Schoenenberger-Berzins R, Messerli FH, Schoenenberger AW, Foster-Witassek F, Rickli H, Pedrazzini G, Roffi M, Puhan M, Radovanovic D. Management of Acute Coronary Syndromes: Is the Yentl Syndrome Vanishing? J Am Heart Assoc. 2026 Aug 20:e049890. doi: 10.1161/JAHA.125.049890. Online ahead of print.
- Derived from this study: PubMed 37348272Roberto M, Hoepli A, Cattaneo M, Radovanovic D, Rickli H, Erne P, Pedrazzini GB, Moccetti M. Patients With AMI and Severely Reduced LVEF, a Well-Defined, Still Extremely Vulnerable Population (Insights from AMIS Plus Registry). Am J Cardiol. 2023 Aug 1;200:190-201. doi: 10.1016/j.amjcard.2023.05.027. Epub 2023 Jun 20.
- Derived from this study: PubMed 34171919Roberto M, Radovanovic D, Butta C, Tersalvi G, Krull J, Erne P, Rickli H, Pedrazzini GB, Moccetti M. Dual antiplatelet therapy is under-prescribed in patients with surgically treated acute myocardial infarction. Interact Cardiovasc Thorac Surg. 2021 Oct 29;33(5):687-694. doi: 10.1093/icvts/ivab159.
- Derived from this study: PubMed 31300969Bruggmann C, Iglesias JF, Gex-Fabry M, Fesselet R, Vogt P, Sadeghipour F, Voirol P. Long-Term Quality of Prescription for ST-Segment Elevation Myocardial Infarction (STEMI) Patients: A Real World 1-Year Follow-Up Study. Am J Cardiovasc Drugs. 2020 Feb;20(1):105-115. doi: 10.1007/s40256-019-00361-5.
- Derived from this study: PubMed 29177059Radovanovic D, Seifert B, Roffi M, Urban P, Rickli H, Pedrazzini G, Erne P. Gender differences in the decrease of in-hospital mortality in patients with acute myocardial infarction during the last 20 years in Switzerland. Open Heart. 2017 Nov 14;4(2):e000689. doi: 10.1136/openhrt-2017-000689. eCollection 2017.
- Derived from this study: PubMed 28040280Bertel N, Witassek F, Puhan M, Erne P, Rickli H, Naegeli B, Pedrazzini G, Stauffer JC, Radovanovic D. Management and outcome of patients with acute myocardial infarction presenting with pacemaker rhythm. Int J Cardiol. 2017 Mar 1;230:604-609. doi: 10.1016/j.ijcard.2016.12.047. Epub 2016 Dec 20.
- Derived from this study: PubMed 26757786Schoenenberger AW, Radovanovic D, Windecker S, Iglesias JF, Pedrazzini G, Stuck AE, Erne P; AMIS Plus Investigators. Temporal trends in the treatment and outcomes of elderly patients with acute coronary syndrome. Eur Heart J. 2016 Apr 21;37(16):1304-11. doi: 10.1093/eurheartj/ehv698. Epub 2016 Jan 12.
- Derived from this study: PubMed 25732032Erne P, Radovanovic D, Seifert B, Bertel O, Urban P; AMIS Plus Investigators. Outcome of patients admitted with acute coronary syndrome on palliative treatment: insights from the nationwide AMIS Plus Registry 1997-2014. BMJ Open. 2015 Mar 2;5(3):e006218. doi: 10.1136/bmjopen-2014-006218.
- Derived from this study: PubMed 25348273Wildi K, Cuculi F, Twerenbold R, Marxer T, Rubini Gimenez M, Reichlin T, Haaf P, Monsch R, Marsch S, Hunziker P, Bingisser R, Osswald S, Erne P, Mueller C. Incidence and timing of serious arrhythmias after early revascularization in non ST-elevation myocardial infarction. Eur Heart J Acute Cardiovasc Care. 2015 Aug;4(4):359-64. doi: 10.1177/2048872614557230. Epub 2014 Oct 27.
- Derived from this study: PubMed 24186563Radovanovic D, Seifert B, Urban P, Eberli FR, Rickli H, Bertel O, Puhan MA, Erne P; AMIS Plus Investigators. Validity of Charlson Comorbidity Index in patients hospitalised with acute coronary syndrome. Insights from the nationwide AMIS Plus registry 2002-2012. Heart. 2014 Feb;100(4):288-94. doi: 10.1136/heartjnl-2013-304588. Epub 2013 Nov 1.
- AMIS Plus RegistryLink provided by the sponsor.
Related trials for Acute Coronary Syndrome
Recruiting
CT Stress Myocardial Perfusion, Fractional Flow Reserve and Angiography in Patients With Stable Chest Pain Syndromes
Coronary Artery Disease, Chest Syndrome
Recruiting
WIN Ratio Analysis to Determine a Strategy of Non- Invasive SUpport for Respiratory Failure in the EmeRgency Department
Acute Hypoxic Respiratory Failure, Acute Respiratory Distress Syndrome (ARDS)
RecruitingPhase 4
Early Single Antiplatelet Therapy After IVUS-Guided PCI in Acute Coronary Syndrome
Acute Coronary Syndromes, STEMI
Recruiting
AI-Assisted Interpretation of Cardiac CT in the Emergency Department
Chest Pain, Acute Coronary Syndrome
Enrolling by invitation
Optical Coherence Tomography in Acute Vessel Evaluation
Ischemic Heart Disease, Ischemic Coronary Artery Disease
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.
Paul Erne, MD study director
AMIS Plus Data Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Coronary Syndrome, run by Luzerner Kantonsspital at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 17 Apr 2013. 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 Switzerland. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paul Erne, MD (++41 41 205 51 06, Paul.Erne@luks.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01305785, which also lists 11 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 17 Apr 2013.