Clinical trial NCT01305785: AMIS Plus - National Registry of Acute Myocardial Infarction in Switzerland
Official title: National Registry of Acute Myocardial Infarction in Switzerland
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acute Coronary Syndrome
Lead sponsor: Luzerner Kantonsspital
Sponsor class: OTHER
Collaborators: name: University of Zurich
name: University Hospital, Geneva
name: Insel Gruppe AG, University Hospital Bern
name: University Hospital, Basel, Switzerland
name: Triemli Hospital
name: Kantonsspital Baden
name: Cantonal Hospital of St. Gallen
name: University Hospital Freiburg
name: Cantonal Hospital, Frauenfeld
name: Hospital Centre Biel/Bienne
name: Spital Lachen AG
name: Cardiocentro Ticino
First posted: 2011-03-01
Enrollment: 60000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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. 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:

1. 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
2. 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.

Eligibility criteria: 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Zurich
country: Switzerland
facility: University of Zurich
Study officials:
affiliation: AMIS Plus Data Center
name: Paul Erne, MD
role: STUDY_DIRECTOR
References:
citation: 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.
citation: Roberto 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.
citation: Bruggmann 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.
citation: Radovanovic 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.
citation: Bertel 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.
citation: Schoenenberger 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.
citation: Erne 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.
citation: Wildi 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.
citation: Radovanovic 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.