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Acute coronary syndrome (clinical) DSS 2013- Metadata Online Registry (METeOR)

- 02/09/2016 - 1 Formulaire, 10 Groupes Item, 84 Eléments de données, 1 Langue

Groupes Item: Acute coronary syndrome clinical event cluster, Emergency department stay, Episode of admitted patient care, Episode of care, Establishment, Health service event, Laboratory standard, Non-admitted patient emergency department service episode, Person with acute coronary syndrome, Person

Health sector data set specifications from METeOR, Australia's repository for national metadata standards, developed by the Australian Institute of Health and Welfare (http://meteor.aihw.gov.au/content/index.phtml/itemId/345165) Acute coronary syndrome (clinical) DSS 2013- The Acute coronary syndrome (ACS) data set specification is not mandated for collection but is recommended as best practice if ACS data are to be collected. This data set specification enables individual hospitals or health service areas to develop collection methods and policies appropriate for their service. The scope for the ACS data set specification is to collect data on the period between when a person with ACS symptoms was first referred to a hospital or directly presented at a hospital, and when a person leaves the hospital, either from the emergency department or is discharged from the hospital. Some of the data relevant to the management of patients attending hospital with ACS symptoms is specified for collection at follow-up visits with a specialist or as a non-admitted patient. Acute coronary syndromes reflect the spectrum of coronary artery disease resulting in acute myocardial ischaemia, and span unstable angina, non-ST segment elevation myocardial infarction (NSTEMI) and ST-segment elevation myocardial infarction (STEMI). Clinically these diagnoses encompass a wide variation in risk, require complex and time urgent risk stratification and represent a large social and economic burden. The definitions used in this data set specification are designed to underpin the data collected by health professionals in their day-to-day acute care practice. They relate to the realities of an acute clinical consultation for patients presenting with chest pain/discomfort and the need to correctly identify, evaluate and manage patients at increased risk of a coronary event. The data elements specified in this metadata set provide a framework for: • promoting the delivery of evidenced-based acute coronary syndrome management care to patients; • facilitating the ongoing improvement in the quality and safety of acute coronary syndrome management in acute care settings in Australia and New Zealand; • improving the epidemiological and public health understanding of this syndrome; and • supporting acute care services as they develop information systems to complement the above. This is particularly important, as the scientific evidence supporting the development of the data elements within the ACS data set specification indicate that accurate identification of the evolving myocardial infarction patient or the high/intermediate risk patient leading to the implementation of the appropriate management pathway impacts on the patient's outcome. Having a nationally recognised set of definitions in relation to defining a patient's diagnosis, risk status and outcomes is a prerequisite to achieving the above aims. The ACS data set specification is based on the American College of Cardiology (ACC) Data Set for Acute Coronary Syndrome as published in the Journal of the American College of Cardiology in December 2001 (38:2114-30) as well as more recent scientific evidence around the diagnosis of myocardial infarction presented in the National Heart Foundation of Australia/Cardiac Society of Australia and New Zealand Guidelines for the management of acute coronary syndromes (MJA 2006;184;S1-S32). The data elements are alphabetically listed and grouped in a similar manner to the American College of Cardiology's data set format. These features of the Australian ACS data set should ensure that the data is internationally comparable. Many of the data elements in this data set specification may also be used in the collection of other cardiovascular clinical information. Where appropriate, it may be useful if the data definitions in this data set specification were also used to address data definition needs in non-clinical environments such as public health surveys etc. This could allow for qualitative comparisons between data collected in, and aggregated from, clinical settings (i.e. using application of the ACS data set specification), with that collected through other means (e.g. public health surveys, reports). A set of ACS data elements and standardised definitions can inform the development and conduct of future registries at both the national and local level. The working group formed under the National Heart Foundation of Australia (Heart Foundation) and the Cardiac Society of Australia and New Zealand (CSANZ) initiative was diverse and included representation from the following organisations: the Heart Foundation, the CSANZ, the Australasian College of Emergency Medicine, the Australian Institute of Health and Welfare, the Australasian Society of Cardiac & Thoracic Surgeons, Royal Australian College of Physicians (RACP), RACP - Towards a Safer Culture, National Centre for Classification in Health (Brisbane), the NSW Aboriginal Health & Medical Research Council, the George Institute for International Health, the School of Population Health at the University of Western Australia and the National Cardiovascular Monitoring System Advisory Committee. To ensure the broad acceptance of the data set specification, the working group also sought consultation from the heads of cardiology departments, other specialist professional bodies and regional key opinion leaders in the field of acute coronary syndromes. Metadata and Classifications Unit Australian Institute of Health and Welfare GPO Box 570 Canberra ACT 2601

Global registry of acute coronary events (GRACE) - GRACE Initial Form v3.5

- 25/11/2015 - 1 Formulaire, 17 Groupes Item, 193 Eléments de données, 1 Langue

Groupes Item: General information, Enrollment, Demographics, Medical History, Presentation, ECG Findings, Laboratory, Procedures, Cardiac Cath/Interventions, LVEF, Thrombolytics, Antiplatelets/Antithrombins/Anticoagulants, Other Medications, Medication Contraindications, Lifestyle interventions, In-hospital Events: After Presentation, Discharge status

GRACE is an international observational database of outcomes for patients who are hospitalized with an acute coronary syndrome (ACS). GRACE includes over 200 hospitals in 28 countries that enroll a total of more than 10,000 patients per year. Participating physicians receive confidential quarterly reports showing ther outcomes side-by-side with the aggregate outcomes of all participating hospitals. (http://www.outcomes-umassmed.org/GRACE/overview.aspx)

Eligibility Chest Pain Diagnostic Acute Coronary Syndrome NCT01035047 - Eligibility Criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 22 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion criteria

Clinical decision units (CDUs) improve resource utilization and are a recommended care option by the American College of Cardiology / American Heart Association, but are underutilized in non-low risk chest pain patients due to weaknesses of traditional cardiac testing. Cardiac magnetic resonance imaging (CMR) is sensitive and specific for ischemia, can simultaneously assess cardiac function and myocardial perfusion, and could revolutionize the diagnostic process for intermediate risk patients with chest pain. The primary objective of this trial is to measure the efficiency and safety of a combined CDU-CMR care pathway compared to inpatient care among patients with non-low risk acute chest pain. https://clinicaltrials.gov/ct2/show/NCT01035047

Eligibility RE-DEEM Acute Coronary Syndrome NCT00621855 - Eligibility criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 10 Eléments de données, 1 Langue

Groupes Item: Inclusion criteria, Exclusion criteria

The purpose of this trial is to evaluate the safety and indicators of efficacy of up to 4 doses of orally administered dabigatran etexilate, administered twice daily, compared to placebo when given in addition to dual antiplatelet treatment in patients with an index event (MI) at high risk for new ischaemic cardiovascular events. https://www.clinicaltrials.gov/ct2/show/NCT00621855

Eligibility Ticagrelor Versus Clopidogrel Acute Coronary Syndrome NCT01294462 - Eligibility criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 7 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion criteria

The purpose of the study is to assess the efficacy (prevention of vascular events) and safety (especially bleedings) of Ticagrelor (AZD6140) compared with Clopidogrel, both given on top of low dose aspirin, in Asian/Japanese patients with acute coronary syndrome and a planned percutaneous coronary intervention (PCI). https://clinicaltrials.gov/ct2/show/NCT01294462

Eligibility Vorapaxar Acute Coronary Syndrome NCT00684203 - Eligibility criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 28 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

The study is designed to assess safety and effects of vorapaxar, when added to standard of care (aspirin and clopidigrel), in Japanese subjects with acute coronary syndrome. The study may also provide information about the effect of vorapaxar on preventing heart attack and stroke in this subject population. https://clinicaltrials.gov/ct2/show/NCT00684203

Eligibility Prasugrel vs Clopidogrel Acute Coronary Syndrome NCT00385944 - Eligiblity Criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 15 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

This is a multicenter, randomized, double-blind, cross-over study to compare the pharmacodynamic response in subjects with Acute Coronary Syndrome receiving a 10-mg maintenance dose (MD) of prasugrel compared with a 150-mg maintenance dose of clopidogrel, following a 900-mg loading dose (LD) of clopidogrel. https://clinicaltrials.gov/ct2/show/NCT00385944

Eligibility SWITCHIII Acute Coronary Syndrome NCT00464087 - Eligibility Criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 36 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion criteria

The primary objective of this clinical trial is to evaluate safety of switching from fondaparinux to either unfractionated heparin or bivalirudin for patients experiencing acute coronary syndrome undergoing percutaneous coronary angioplasty. https://clinicaltrials.gov/ct2/show/NCT00464087

Eligibility CHAMPION PHOENIX Acute Coronary Syndrome NCT01156571 - Eligibility Criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 24 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

The study is designed to compare the efficacy and safety profile of cangrelor to standard of care in patients require percutaneous coronary intervention (PCI). https://clinicaltrials.gov/ct2/show/NCT01156571

Eligibility HouYi Acute Coronary Syndrome NCT01864005 - Eligibility criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 16 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

The purpose of this study is to test the hypothesis that the onset of the antiplatelet effect of ticagrelor is more rapid and greater than clopidogrel in Chinese patients with ACS. https://clinicaltrials.gov/ct2/show/NCT01864005

Eligibility Rosuvastatin Acute Coronary Syndrome NCT01241903 - Eligibility Critera

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 20 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion criteria

The central hypothesis for this work is that platelet - leukocyte interactions play a critical role in the pathogenesis of acute ischemic events. The primary objective of the study is to determine if early, high-dose administration of the HMG-CoA reductase inhibitor rosuvastatin in the setting of acute coronary syndrome and percutaneous coronary intervention exerts beneficial vascular effects by reducing platelet - leukocyte interactions. https://clinicaltrials.gov/ct2/show/NCT01241903

Eligibility TIMACS Acute Coronary Syndrome NCT00552513 - Eligibility Criteria

- 21/11/2015 - 1 Formulaire, 2 Groupes Item, 10 Eléments de données, 1 Langue

Groupes Item: Inclusion Criteria, Exclusion Criteria

The timing of intervention study is a prospective, randomized, international, multicentre comparison of the relative efficacy, safety, and cost effectiveness of a management strategy of coronary angiography and intervention performed within 24 hours of randomization versus delayed coronary angiography and intervention in patients after 36 hours with acute coronary syndromes (ACS). https://clinicaltrials.gov/ct2/show/NCT00552513

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