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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT01305785
Other study ID # AMIS Plus
Secondary ID
Status Recruiting
Phase N/A
First received February 28, 2011
Last updated April 16, 2013
Start date January 1997

Study information

Verified date April 2013
Source Luzerner Kantonsspital
Contact Paul Erne, MD
Phone ++41 41 205 51 06
Email Paul.Erne@luks.ch
Is FDA regulated No
Health authority Swiss Society of Cardiology, Medicine and Intensive Care: 'Switzerland'
Study type Observational

Clinical 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. 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 60000
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
Switzerland University of Zurich Zurich

Sponsors (13)

Lead Sponsor Collaborator
Luzerner Kantonsspital Cantonal Hospital of St. Gallen, Cantonal Hospital, Frauenfeld, Cardiocentro Ticino, Hospital Centre Biel/Bienne, Kantonsspital Baden, Spital Lachen AG, Triemli Hospital, University Hospital Freiburg, University Hospital Inselspital, Berne, University Hospital, Basel, Switzerland, University Hospital, Geneva, University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

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. — View Citation

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