Tjitske van Engelen

189 Classifying study participants in clinical trials • A medical history of coronary artery disease, arterial hypertension, exposure to cardiotoxic drugs or radiation, usage of diuretics, orthopnea or paroxysmal nocturnal dyspnea. • A physical examination that reveals rales, bilateral edema of the ankles, heart murmur, elevated central venous pressure. • An electrocardiogram (ECG) that shows widened QRS and / or pathologic Q-waves. AND at least one of the following: • At Academic Medical Center: N-terminal pro b-type natriuretic peptide (NTproBNP) ≥ 300 pg/mL OR at Spaarne Gasthuis: B-type natriuretic peptide (BNP) ≥ 28.9 pmol/L. • Abnormal echocardiography at ED presentation. If echocardiography is normal at ED presentation, or unchanged compared to pre-existent abnormalities, there is no cardiac failure. AND: • Treatment was started, for instance diuretics were given or the dosage of preexisting diuretics was increased. Exception: • When there is no NT-proBNP or BNP measurement done during ED presentation, but there is a very high clinical suspicion of cardiac failure and treatment for cardiac failure was started, strongly consider this diagnostic label. When in doubt, refer this case to the Adjudication Committee. • Review critically if the patient indeed has the abovementioned symptoms due to cardiac failure or that symptoms are due to an underlying non-cardiac disease, such as renal asthma. The latter should be assigned the diagnostic label “Other thoracic pathology”. References: [18, 19] 22. Pericarditis Please assign this diagnostic label when at least 2 of the following symptoms are present: • Chest pain • Pericardial rub • Diffuse ST elevation of PR depression on ECG • Pericardial effusion on medical imaging Exceptions: • The patient has only one of the required symptoms, but has additional characteristics. Additional characteristics are elevated levels of C-reactive protein (CRP) or erythrocyte sedimentation rate (ESR), or signs of inflammation on magnetic resonance imaging (MRI) or positron emission tomography (PET)-scan. The additional characteristics can be a sign of complexity of the case. Please refer this case to the Adjudication Committee. • The ED report or follow-up information states “perimyocarditis”. Please refer this case to the Adjudication Committee. References: [1, 20] 8

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