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- Ensaio Clínico NCT01954303
HsTnT in Stable Coronary Artery Disease
Elevated High-sensitivity Cardiac Troponin T Levels in Patients With Stable Coronary Artery Disease
Coronary artery disease (CAD) is one of the leading causes of morbidity and mortality worldwide. Life threatening manifestations such as acute myocardial infarction (AMI) and sudden cardiac death are the most important causes of death in many countries. Cardiac troponin is a biomarker with a high specificity for cardiac necrosis and is recommended for diagnosis of acute myocardial infarction by the Universal definition of myocardial infarction. Since a new generation of high-sensitivity cardiac troponin assays has become commercially available a few years ago, myocardial infarction can be detected earlier and even small AMIs, that were classified as unstable angina pectoris (UAP) with the less sensitive assays, are detectable now. On the other side, more patients with acute or chronic myocardial damage not due to AMI are identified now. Thereby, the reason for elevated troponin levels should be sought actively, because high troponin levels were associated with adverse outcome - independent of the underlying pathomechanism. The reasons for troponin elevations in patients with stable CAD are not clear yet. Associations with extensive atherosclerosis, carotid lesions and complex coronary plaques in coronary CT scans were reported. Therefore, patients with elevated troponin levels represent a risk population and might profit from intensified secondary prevention. In this context, ticagrelor might be part of a prevention strategy as currently tested in the PEGASUS trial.
We plan to conduct a single-centre pilot study in a cohort with clinically stable patients of our outpatient clinic, because data regarding prevalence, causes and prognosis of elevated troponin values in unselected cohorts is sparse. Therefore, all patients (n=910) that presented to our outpatient clinic 12 months after introduction of the high-sensitivity troponin T assay (june 2009) and were free of complaints or presented with UAP are being enrolled. All patients are characterized by demographic, laboratory and clinical characteristics (including medication) and all available imaging data (exercise-ecg, echocardiography, stress-echocardiography, computed tomography, cardiac MRI and coronary angiography) in order to compare baseline characteristics of troponin positive and troponin negative patients. In addition, the Framingham- and PROCAM-Score representing established calculators of long-term risk prediction are calculated.
Prognostic endpoints are defined as severe cardiovascular events and progress of the initially diagnosed disease. Those endpoints are associated with the initial hs-cTnT value and serial changes.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
We plan to conduct a single-centre pilot study in a cohort with clinically stable patients (n=910) of our outpatient clinic who presented 12 months after introduction of the high-sensitivity troponin T assay (june 2009) for routine workup. No patients will be excluded.
All patients with stable CAD with or without cardiovascular comorbidities will be selected and classified as "troponin positive" or "troponin negative" according to initially documented hs-cTnT value.
Descrição
Inclusion Criteria:
- Patients of outpatient clinic presenting 12 months after introduction of the hs-TnT test in june 2009
Exclusion Criteria:
- none
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
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Troponin status
Patients are divided into "troponin positive" (if hsTnT on first presentation is <14 ng/L) and "troponin negative" (if hsTnT on first presentation is >=14 ng/l).
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Progress of CHD
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
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Morte cardiovascular
Prazo: 3 anos
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3 anos
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Medidas de resultados secundários
Medida de resultado |
Prazo |
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Recurrent Myocardial Infarction
Prazo: 3 years
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3 years
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Outras medidas de resultado
Medida de resultado |
Prazo |
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Recurrent coronary intervention
Prazo: 3 years
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3 years
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Colaboradores e Investigadores
Patrocinador
Colaboradores
Publicações e links úteis
Publicações Gerais
- Biener M, Giannitsis E, Hogrefe K, Mueller-Hennessen M, Frohlich H, Katus HA, Frey N, Frankenstein L, Tager T. Prognostic value of changes in high-sensitivity cardiac troponin T beyond biological variation in stable outpatients with cardiovascular disease: a validation study. Clin Res Cardiol. 2022 Mar;111(3):333-342. doi: 10.1007/s00392-021-01952-6. Epub 2021 Oct 25.
- Tager T, Giannitsis E, Greve K, Frohlich H, Muller-Hennessen M, Vafaie M, Katus HA, Frankenstein L, Biener M. Long-term biological variation of high-sensitivity cardiac troponin T using minimal important differences and reference change values in stable outpatients with cardiovascular disease. Clin Biochem. 2019 May;67:7-11. doi: 10.1016/j.clinbiochem.2019.03.003. Epub 2019 Mar 11.
- Biener M, Giannitsis E, Kuhner M, Zelniker T, Mueller-Hennessen M, Vafaie M, Stoyanov KM, Neumann FJ, Katus HA, Hochholzer W, Valina CM. Risk prediction in stable cardiovascular disease using a high-sensitivity cardiac troponin T single biomarker strategy compared to the ESC-SCORE. Open Heart. 2018 Apr 25;5(1):e000710. doi: 10.1136/openhrt-2017-000710. eCollection 2018.
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UHHD-BM-001
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