AMIS Plus - National Registry of Acute Myocardial Infarction in Switzerland

This study is currently recruiting participants. (see Contacts and Locations)
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
  Purpose

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.


Condition
Acute Coronary Syndrome

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: National Registry of Acute Myocardial Infarction in Switzerland

Resource links provided by NLM:


Further study details as provided by Luzerner Kantonsspital:

Estimated Enrollment: 60000
Study Start Date: January 1997
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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01305785

Contacts
Contact: Paul Erne, MD ++41 41 205 51 06 Paul.Erne@luks.ch

Locations
Switzerland
University of Zurich Recruiting
Zurich, Switzerland
Contact: Dragana Radovanovic         
Sponsors and Collaborators
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
Investigators
Study Director: Paul Erne, MD AMIS Plus Data Center
  More Information

Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Prof. Paul Erne, AMIS Plus Steering Committee President, Luzerner Kantonsspital
ClinicalTrials.gov Identifier: NCT01305785     History of Changes
Other Study ID Numbers: AMIS Plus
Study First Received: February 28, 2011
Last Updated: April 16, 2013
Health Authority: Swiss Society of Cardiology, Medicine and Intensive Care: 'Switzerland'

Additional relevant MeSH terms:
Infarction
Myocardial Infarction
Acute Coronary Syndrome
Ischemia
Pathologic Processes
Necrosis
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases
Angina Pectoris
Chest Pain
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on July 26, 2014