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Kerndatensatz Herzinsuffizienz DZHI (Core data set heart failure CHFC) - Untersuchung Herzinsuffizienz (Examination heart failure)

- 3/24/20 - 1 form, 5 itemgroups, 90 items, 2 languages
Itemgroups: Logistics , Physical examination, ECG, 6MWT, Echocardiography
Core data set on heart failure, developed by the Comprehensive Heart Failure Center (CHFC). The CHFC researches and treats the complex disease heart failure and its comorbidities in a comprehensive approach. This form contains information about the examination of an heart failure Kerndatensatz zu Herzinsuffizienz, entwickelt vom Deutschen Zentrum für Herzinsuffizienz (DZHI). Das DZHI erforscht und therapiert in einem ganzheitlichen Ansatz die Systemerkrankung Herzinsuffizienz samt ihrer Begleit- und Folgeerkrankungen. Dieses Formular enthält Informationen über die Untersuchung einer Herzinsuffizienz.

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Baseline Visit

- 11/14/17 - 1 form, 10 itemgroups, 71 items, 2 languages
Itemgroups: Physical Examination / Medical History taking, Signs and Symptoms of heart failure, Cardiovascular Diseases, Comorbidities, Current medication, Cardiovascular interventions, Implantation of a cardiac device, Hematology, ECG, Baseline visit
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Baseline Visit (BV-Form)

CEC - MI GSK study Chronic Coronary Heart Disease NCT00799903

- 1/11/18 - 1 form, 3 itemgroups, 28 items, 1 language
Itemgroups: CEC - MI, Myocardial infarction - CEC Section, CEC STATUS
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: CEC - MI Repeating form (Scheduled visits)

Vital signs GSK study Chronic Coronary Heart Disease NCT00799903

- 12/20/17 - 1 form, 2 itemgroups, 13 items, 1 language
Itemgroups: Vital signs, Additional vital signs
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Vital signs

Anaphylaxis diagnosis Repeating form GSK study Chronic Coronary Heart Disease NCT00799903

- 1/1/18 - 1 form, 1 itemgroup, 16 items, 1 language
Itemgroup: Anaphylaxis diagnosis
Study ID: 100601 Clinical Study ID: LPL100601 Study Title: LPL100601, A Clinical Outcomes Study of Darapladib versus Placebo in Subjects with Chronic Coronary Heart Disease to Compare the Incidence of Major Adverse Cardiovascular Events (MACE) Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Clinicaltrials.gov Identifier: NCT00799903 Sponsor: GlaxoSmithKline Collaborators: N/A Phase: phase 3 Study Recruitment Status: Completed Generic Name: darapladib Trade Name: darapladib Study Indication: Atherosclerosis Study part: Anaphylaxis diagnosis - Repeating form (Scheduled visits)

Telemedical Interventional Management in Heart Failure II (TIM-HF II) NCT01878630 - Patient visit

- 11/14/17 - 1 form, 7 itemgroups, 43 items, 2 languages
Itemgroups: Patient visit, Physical Examination / Medical History taking, Signs and Symptoms of heart failure, ECG, Utilisation of health care resources since last visit, Hematology, Current medication
Short title: TIM-HF II Permission to publish granted by: Prof. Dr. Friedrich Köhler, FESC Charité - Universitätsmedizin Berlin Further study details on: https://www.clinicaltrials.gov/ct2/show/NCT01878630 Patient visit (Z-form)

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

- 9/2/16 - 1 form, 10 itemgroups, 84 items, 1 language
Itemgroups: 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

Ankle-Arm Index CARLA

- 9/17/21 - 1 form, 11 itemgroups, 42 items, 2 languages
Itemgroups: General information, Circumference measurement, BP measurement I, BP measurement II, BP measurement II: No. 1, BP measurement II: No. 2, BP measurement III, BP measurement III: No. 1, BP measurement III: No. 2, Further information, Data entry
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Blood pressure measurement CARLA Follow-up

- 9/17/21 - 1 form, 5 itemgroups, 30 items, 2 languages
Itemgroups: General information, After 5 min. (Measurement I), After 3 min. (Measurement II), After 3 min. (Measurement III), Data entry
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Blood pressure measurement CARLA - Blood pressure measurement CARLA

- 9/17/21 - 1 form, 5 itemgroups, 26 items, 2 languages
Itemgroups: General information, After 5 min. (Measurement I), After 3 min. (Measurement II), After 3 min. (Measurement III), Data entry
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Ankle-Arm Index CARLA Follow-up

- 9/17/21 - 1 form, 12 itemgroups, 44 items, 2 languages
Itemgroups: General information, Circumference measurement, Pulse of anterior tibial artery, BP measurement I, BP measurement II, BP measurement II: No. 1, BP measurement II: No. 2, BP measurement III, BP measurement III: No. 1, BP measurement III: No. 2, Further information, Data entry
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

Anthropometry Record CARLA Follow-up

- 2/6/18 - 1 form, 4 itemgroups, 16 items, 2 languages
Itemgroups: General information, Anthropometry, Transition to AAI measurement and ECG, Data entry
Greiser KH, Kluttig A, Schumann B, Swenne CA, Kors JA, Kuss O, Haerting J, Schmidt H, Thiery J, Werdan K. Cardiovascular diseases, risk factors and short-term heart rate variability in an elderly general population: the CARLA study 2002-2006. Eur J Epidemiol. 2009;24(3):123-42 http://www.ncbi.nlm.nih.gov/pubmed/19199053 "Cross-sectional data of a population-based cohort including 1,779 women and men aged 45-83 years were used to analyse associations of time and frequency domain measures of HRV (derived from 5-min ECG segments) with age, behavioural and biomedical risk factors and disease in the whole sample and in a "healthy" subgroup." publication granted by Dr. rer. medic. Alexander Kluttig, MPH Leiter des Studienzentrums Halle der Nationalen Kohorte Institut für Medizinische Epidemiologie, Biometrie und Informatik Martin-Luther-Universität Halle-Wittenberg Magdeburger Str. 8 D-06097 Halle/Saale

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