Physical Examination and Sociodemographic Data
Defined as the data which appears on the person’s identity card
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Defined as the data which appears on the person’s identity card. Timestamp with month and year.
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Height is measured in the standing position, without shoes and without head covering. Preferentially, measured data should be collected; only when this is not possible (e.g. in the case of bed-ridden patients) should one estimate the values or resort to information provided by the proband.
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Weight is measured in normal street clothing, without a jacket and without shoes. Preferentially, measured data should be collected; only when this is not possible (e.g. in the case of bed-ridden patients) should one estimate the values or resort to information provided by the proband.
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A person’s ethnic origin is defined by their ancestry in relation to a specific ethnic group. This can be determined biologically and/or geographically on the basis of membership of a certain settlement group.
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Accordingly, a person’s skin colour can also be broadly defined. The colour spectrum can be differentiated from light to dark skin colour.
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Defined as a medically diagnosed myocardial infarction or stroke in one or both biological parents, biological siblings (including half-siblings) or biological children, provided the female relative was under age 65, or the male relative under age 55 (when the myocardial infarction/stroke occurred).
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Cardiovascular risk factors
Defined as diabetes which has been diagnosed and/or treated by a doctor. The American Diabetes Association criteria are: - haemoglobin A1c ≥ 6.5 % or a fasting blood glucose level of ≥ 126 mg/dl or a - 2-hour blood glucose level of ≥ 200 mg/dl in the oral glucose tolerance test.
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Defined as a current or previous diagnosis of arterial hypertension which was diagnosed and/or is being treated by a doctor. Treatment can consist of e.g. dietary changes, physical activity and/or medication. Systolic blood pressure values ≥ 140 mmHg and/or diastolic blood pressure values ≥ 90mmHg measured by a doctor on at least two separate days after a 5-minute resting phase qualify for a diagnosis of arterial hypertension
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Defined as a current or previous diagnosis of dyslipidaemia which was diagnosed and/or is being treated by a doctor. One or more of the following criteria: - total cholesterol ≥ 200 mg/dl, - LDL cholesterol ≥ 130 mg/dl, - HDL cholesterol < 40 mg/dl (men) and < 50 mg/dl (women).
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Defined as current or previous use of cigarettes, cigars, pipes or smokeless tobacco. “Yes” for daily or occasional smoking (≥ 1x/month); “Ex-smoker“ for abstinence of more than 6 months; ex-smoker since …; “No“ for “never smoked“.
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Timestamp with year
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It is the product of the number of years of cigarette smoking multiplied by the average number of packs smoked per day. Example: A patient who has smoked 2 packets of cigarettes per day for 20 years has 40 pack years.
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This is the number of alcoholic drinks consumed per week. One drink is defined as e.g. 0.25 l of beer, 0.1 l of wine or 0.02 l of spirits. Example: A patient who drinks 0.5 l beer on average two times every week has 4 drinks per week.
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Defined as a current or previous diagnosis of alcoholism which was diagnosed and/or is being treated by a doctor.
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This includes all patients who exhibit reduced renal function.
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If known, the degree of renal dysfunction should be quantified by the estimated Glomerular Filtration Rate (eGFR). Different estimation methods exist; if available, the formula that follows the MDRD formula should be used.
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Defined as current regular, at least weekly, renal replacement therapy (including haemodialysis and peritoneal dialysis) within the last 30 days.
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Cardiac Diagnoses (Anamnesis and Previous Findings)
Defined as a current or previous diagnosis by a doctor with one or more of the following criteria: - coronary artery stenosis of ≥ 50 per cent (diagnosed by cardiac catheterization or another direct coronary artery imaging method), - prior coronary artery bypass operation, - prior percutaneous coronary intervention, - arteriosclerosis-induced myocardial infarction.
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Defined as a diagnosis of the disease by a doctor. Explanation: Acute myocardial infarction is defined as demonstrated evidence of myocardial necrosis in a clinical setting which is consistent with myocardial infarction. One or more of the following criteria must apply: Evidence of an increase or decrease of a cardiac biomarker (preferably troponin) with at least one value above the 99 % percentile of the upper reference limit and, additionally, at least one of the following factors: - symptoms of ischaemia, angina pectoris, - ECG changes indicative of new ischaemia, e.g. ST segment elevations or a new left bundle branch block, development of pathological Q waves in the ECG, - imaging studies show a loss of viable myocardial tissue or new regional wall motion abnormalities - angiographic evidence of stenosis/blood vessel blockage.
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Defined as a diagnosis by a doctor of a primary heart muscle disease. If the question is answered with “yes”, please complete the Cardiomyopathy Diagnostics form.
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Defined as a current or previous diagnosis and documentation by a doctor of heart failure, based on the following symptoms: shortness of breath with mild exertion, recurrent shortness of breath when sitting, fluid overload or pulmonary rales, distention of the neck veins, pulmonary oedema on physical examination or pulmonary oedema on chest x-rays. Documentation of reduced left ventricular function alone in the absence of clinical signs of heart failure does not meet the criteria for heart failure
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Status post decompensation is defined as any previous admission to a hospital with symptoms of heart failure (see above).
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Initial diagnosis of heart failure is defined as the time point when heart failure was diagnosed for the first time by a doctor. Hence it does not refer to the time point of first onset of symptoms, which is often much earlier. Timestamp with year.
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NYHA class
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Defined as a current or previous diagnosis by a doctor of atrial fibrillation or atrial flutter. It is defined as an episode of atrial fibrillation or atrial flutter lasting at least 30 seconds or atrial fibrillation with evidence on the surface ECG or during pacemaker interrogation.
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Defined as heart valve disease (incompetence or stenosis), which has been diagnosed and/or treated by a doctor.
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If at any time, currently or in their previous medical history, a patient has been diagnosed by a doctor with endocarditis (heart valve inflammation), it will be documented here.
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If a patient has a known congenital heart defect, it will be coded here. Congenital heart defects include shunt defects (e.g. ASD, VSD), congenital valvular heart diseases (e.g. pulmonary stenosis) and cardiomyopathies diagnosed in the first five years of life.
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Previous cardiovascular interventions
Defined as a percutaneously performed intervention on a coronary artery, e.g. PTCA, stent implantation, rotablation et cetera.
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Where applicable, the date of the last intervention should be entered. Timestamp with month and year.
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Defined as a percutaneously performed intervention on a peripheral artery (not including coronary arteries or bypass grafts) e.g. PTA, stent implantation, rotablation et cetera.
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Where applicable, the date of the last intervention should be entered. Timestamp with month and year.
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Defined as operative myocardial revascularization by means of a bypass graft (e.g. from the internal thoracic artery or using arterial/venous grafts). Where applicable, the date of the most recent operation should be entered.
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Where applicable, the date of the most recent operation should be entered. Timestamp with month and year.
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Defined as an operation of any kind on non-coronary blood vessels.
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Where applicable, the date of the most recent operation should be entered. Timestamp with month and year.
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Defined as a minimally invasive percutaneous (catheter-based) or open surgical procedure on a heart valve.
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Where applicable, the date of the most recent operation should be entered. Timestamp with month and year.
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The most recent event is to be coded according to type, whereby any transapical aortic valve replacements are to be coded as “catheter-based“.
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In addition, details of the surgical procedure should be given.
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If more than one procedure on one valve was performed, please provide details of the last Op (= current state)
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If more than one procedure on one valve was performed, please provide details of the last Op (= current state)
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If more than one procedure on one valve was performed, please provide details of the last Op (= current state)
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If more than one procedure on one valve was performed, please provide details of the last Op (= current state)
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If more than one procedure on one valve was performed, please provide details of the last Op (= current state)
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Defined as status post implantation of a cardiac pacemaker or intracardiac defibrillator.
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Type of cardiac implant
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Where applicable, the date of the most recent operation (implantation/exchange) is to be entered. Timestamp with month and year.
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In addition, the number of leads currently connected to the pacemaker power supply should be coded. A device with only one lead should be coded as a 1-chamber pacemaker, a device with an atrial and a ventricular lead should be coded as a 2-chamber pacemaker. Devices for cardiac resynchronization therapy, with 2 ventricular leads, should be coded as biventricular (CRT) pacemakers.
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Defined as other implantable devices for cardiac/vascular support. This includes devices for cardiac contractility modulation, for neuromodulation (e.g. vagus nerve stimulator, baroreceptor stimulator), intra-aortic balloon pumps and left ventricular cardiac assist devices.
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Cardiac contractility modulation
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Intra-aortic balloon pump
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Other implantable cardiac/cardiovascular devices
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Defined as status post bioptic removal of tissue from the heart muscle (e.g. during a right/left catheter examination or operation).
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Where applicable, the date of the most recent myocardial biopsy should be coded. Timestamp with month and year.
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Where applicable, the sampling site should be coded.
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Current secondary diagnoses
Defined as a current or previous diagnosis by a doctor of peripheral arterial occlusive disease (in the blood vessels of the pelvis and legs, or from the upper extremity of the subclavian artery to the distal extremity). Renal, coronary, cerebral and mesenteric blood vessels and aneurysms are excluded. Possible symptoms are: - intermittent claudication, - amputation due to severe arterial vascular insufficiency, - vascular reconstruction, bypass operation or percutaneous revascularization, - a positive non-invasive test (e.g. ankle-brachial index of ≤ 0.9, pathological TCPO2 measurement, evidence of 50 per cent or greater stenosis of a peripheral artery by Doppler/duplex sonography, CT, MRT, or angiography).
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Classification of the degree of severity is done according to the Fontaine classification: Stage I: Asymptomatic PAOD Stage II: Intermittent claudication with walking distances > 200 metres (Stage IIa) with walking distances < 200 metres (Stage IIb) Stage III: Pain at rest Stage IV: Necrosis, gangrene trophic disorder, dry necroses (Stage IVa) bacterial infection of the necrosis, wet gangrene (Stage IVb)
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Acute ischaemic occlusion describes a recent (in the last 30 days) occurrence of demonstrated acute ischaemic occlusion of a peripheral arterial vessel.
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Defined as a current or previous diagnosis by a doctor.
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Timestamp with month and year.
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Ischaemic stroke: Infarction of tissue of the central nervous system, either symptomatic or silent (asymptomatic). Transient ischaemic attack (TIA): A transient episode of neurological dysfunction caused by focal brain, spinal cord or retinal ischaemia without acute infarction which resolves completely within 24 hours. This definition is not met by chronic (non-vascular) neurological diseases or other acute neurological diseases such as metabolic or ischaemic encephalopathy resulting from general hypoxia (e.g. in the case of respiratory insufficiency, following a cardiac/circulatory arrest). Haemorrhagic stroke: Neurological dysfunction caused by intra-cranial bleeding. Stroke where there is uncertainty as to whether the cause was haemorrhagic or ischaemic.
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Ischaemic stroke: Infarction of tissue of the central nervous system, either symptomatic or silent (asymptomatic). Transient ischaemic attack (TIA): A transient episode of neurological dysfunction caused by focal brain, spinal cord or retinal ischaemia without acute infarction which resolves completely within 24 hours. This definition is not met by chronic (non-vascular) neurological diseases or other acute neurological diseases such as metabolic or ischaemic encephalopathy resulting from general hypoxia (e.g. in the case of respiratory insufficiency, following a cardiac/circulatory arrest). Haemorrhagic stroke: Neurological dysfunction caused by intra-cranial bleeding. Stroke where there is uncertainty as to whether the cause was haemorrhagic or ischaemic.
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A stroke is described as “minor“ when the neurological symptoms can be completely reversed within 30 days or the change in the NIH Stroke Scale (see Appendix 7.3 NIH Stroke Scale) amounts to less than 3 points in comparison with the NIH Stroke Scale before the stroke. A stroke is described as “major” when a neurological deficit can still be demonstrated 30 days after the event or the NIH Stroke Scale is at least 3 points higher than prior to the stroke.
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A stroke is described as “disabling” when more than 2 points are scored on modified Rankin Scale 90 days after the stroke. If the modified Rankin Scale score is 2 points or less 90 days after the stroke, the stroke is described as “non-disabling”. The modified Rankin Scale from 0 to 6 describes states from full health to death. 0 - No symptoms. 1 - No significant disability. Can perform day-to-day activities despite some symptoms. 2 - Slight disability. Is able to care for him or herself without assistance, but is restricted in day-to-day activities. 3 - Moderate disability. Requires assistance in daily life, but is able to walk without assistance. 4 - High level of disability. Requires assistance with personal hygiene; is not able to walk without assistance. 5 - Severe disability. Confined to bed, incontinent, requires constant nursing care. 6 – Death caused by apoplexy.
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Defined as a diagnosis by a doctor of a chronic lung disease (e.g. COPD, chronic bronchitis, pulmonary fibrosis) and/or their pharmacological treatment, for example, with inhalable or oral pharmaceuticals.
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Defined as a diagnosis and/or treatment by a doctor of primary pulmonary hypertension.
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defined as a current or previous diagnosis by a doctor. The administration of antidepressants alone does not qualify for a diagnosis of depression. If the response to this question is “yes”, please complete the “Depression” form.
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Defined as a current or previous diagnosis of a malignant cancer. Basal cell carcinoma does not belong to malignancy.
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Defined as malignant cancer diagnosed by a doctor less than 5 years ago. Basal cell carcinoma is not counted as a malignancy.
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Anamnestic questions for women only
Menopause is defined as the time point of the last spontaneous menstrual period in the life of a woman after which no further bleeding from the uterus induced by the ovaries occurs for at least 12 months. The year in which the menopause began is to be coded.
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Timestamp with year
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The day on which the last menstrual period began is required only for perimenopausal women. Timestamp with year, month and day.
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Blood pressure after 5 minutes at rest
The systolic blood pressure should be measured using a blood pressure monitor that is serviced and calibrated on a regular basis. Where possible, tested devices (e.g. Omron 705 IT) should be used for epidemiological trials. Blood pressure measurement begins after the patient has been at rest for at least 5 minutes. Three readings are taken at intervals of 2 minutes; the average values of the second and third readings are entered.
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Blood pressure measurement begins after the patient has been at rest for at least 5 minutes. Three readings are taken at intervals of 2 minutes; the average values of the second and third readings are entered.
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Heart rate after sitting down for 5 minutes
Measurement of the heart rate begins after the patient has been sitting down for at least 5 minutes. This should take place after measuring the blood pressure. This should be done manually by counting the radial pulse for 30 seconds; that value multiplied by two should be entered.
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Further diagnoses
A patient who complains of shortness of breath with physical exertion within the last 14 days and/or at present. In cases of known heart failure, for patients in NYHA stages II-IV, dyspnoea on exertion should be coded.
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A patient who complains of shortness of breath even when at rest (e.g. when talking) within the last 14 days and/or at present. In cases of known heart failure, for patients in NYHA stage IV, dyspnoea at rest should be coded.
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A patient who complains of bilateral accumulation of fluid in the extremities within the last 14 days and/or at present, whether clinically observed or perceived by the patient
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The diagnostic test for jugular venous distention is conducted with the upper body of the patient positioned at a 45° angle. The level at which the jugular vein collapses is then determined. A non-pathological finding is if the vein collapses at latest at the level of the supra-sternal notch, which normally corresponds to an 8 cm water column or 5-6 mmHg before the right atrium. If the jugular vein collapses above the supra-sternal notch, jugular venous distention must be coded.
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Defined as sounds heard over the lung during auscultation which are created by the movement of fluids and/or secretions during inspiration and expiration. They belong to the category of adventitious breath sounds overlying normal breath sounds and indicate a pathological change in the lung.
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Laboratory diagnostics (blood)
Where applicable, give date for the oldest value. Timestamp with year, month and day.
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Haemoglobin
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Haemoglobin Unit
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Creatinine (serum, heparin plasma)
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Creatinine Unit
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The original data type for this item is a four-digit integer.
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Total cholesterol Unit
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