AMIS Plus - National Registry of Acute Myocardial Infarction in Switzerland

This study is currently recruiting participants.
Verified April 2013 by Luzerner Kantonsspital
Sponsor:
Collaborators:
University of Zurich
University Hospital, Geneva
University Hospital Inselspital, Berne
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
Information provided by (Responsible Party):
Prof. Paul Erne, Luzerner Kantonsspital
ClinicalTrials.gov Identifier:
NCT01305785
First received: February 28, 2011
Last updated: April 16, 2013
Last verified: April 2013

February 28, 2011
April 16, 2013
January 1997
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Complete list of historical versions of study NCT01305785 on ClinicalTrials.gov Archive Site
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AMIS Plus - National Registry of Acute Myocardial Infarction in Switzerland
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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
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Probability Sample

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.
Acute Coronary Syndrome
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
60000
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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.

Both
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Contact: Paul Erne, MD ++41 41 205 51 06 Paul.Erne@luks.ch
Switzerland
 
NCT01305785
AMIS Plus
No
Prof. Paul Erne, Luzerner Kantonsspital
Luzerner Kantonsspital
  • University of Zurich
  • University Hospital, Geneva
  • University Hospital Inselspital, Berne
  • 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 Director: Paul Erne, MD AMIS Plus Data Center
Luzerner Kantonsspital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP