- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT02309255
The NOR-COR Study for Coronary Prevention
The NOR-COR (NORwegian CORonary) Study: Identification of CHD Patients With Poor Adherence to Secondary Prevention and Their Perceived Needs for Follow-up
The NOR-COR study is a cross-sectional, observational study designed to explore a large number of cardiovascular, inflammatory, genetic, behavioral, and psychosocial factors (including anxiety, depression, quality of life) in 1369 patients with established coronary heart disease (CHD) hospitalized in the Sections for Cardiology at the hospitals in Drammen (n=722) and Vestfold (n=647). Study data from an extensive questionnaire, clinical and laboratory data, and sputum/saliva for genetic analyses will be collected.
The main overall aim of the NOR-COR study is to develop new strategies to improve secondary prevention for underserved high risk patient-groups with CHD. The first study phase aims to collect information necessary to develop empirically based future secondary coronary prevention interventions. In a genetic sub-project markers associated with CHD and personality type will be explored.
The study will evaluate current secondary preventive programs and explore the mechanisms that link behavioral, psychosocial, inflammatory, and genetic factors to poor prognosis. The study will in short term provide new knowledge potentially useful for increasing participation in current cardiac rehabilitation/secondary preventive programs. For a longer perspective these associations may be useful for design of new intervention programs to selected high risk patient groups whom may be in need of programs with different content and/or of longer duration than those currently being applied.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Buskerud and Vestfold
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Drammen and Tønsberg, Buskerud and Vestfold, Noruega, N-3004
- Vestre Viken HF, Drammen Hospital and The Hospital of Vestfold
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion criteria:
All patients aged 18-80 years with first or recurrent diagnosis or treatments for CHD: a) acute myocardial infarction [ICD-10; I21], b) coronary artery by-pass graft operation (CABG), or c) elective or emergency PCI [ICD-10; I25]) have been identified from hospital patient discharge lists (diagnostic lists) by searching chronologically after last admission the past three years. In patients with recurrent diagnosis the last event will define the event.
Exclusion Criteria:
- Cognitive impairment that would invalidate assessment including all patients living at nursing home and psychosis.
- Short life expectancy (i.e. <1 year) due to terminal heart (NYHA class 4), lung (chronic obstructive pulmonary disease GOLD 4)-, liver- or kidney disease (chronic kidney disease stage 5), malignant disease, or other reason.
- Not able to understand and write the Norwegian language or refuse to give written informed consent to study participation.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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coronary heart disease patients
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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Cardiovascular risk factors, lifestyle, and drug adherence
Prazo: Within 2 years after study inclusion
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Within 2 years after study inclusion
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Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
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Readmission with a coronary event, acute myocardial infarctrion and cardiovascular mortality
Prazo: Within 5 years after study inclusion
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Within 5 years after study inclusion
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Outras medidas de resultado
Medida de resultado |
Prazo |
|---|---|
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The hospital anxiety and depression scale (HADS)
Prazo: Within 2 years after study inclusion
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Within 2 years after study inclusion
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Colaboradores e Investigadores
Patrocinador
Publicações e links úteis
Publicações Gerais
- Sverre E, Peersen K, Perk J, Husebye E, Gullestad L, Dammen T, Otterstad JE, Munkhaugen J. Challenges in coronary heart disease prevention - experiences from a long-term follow-up study in Norway. Scand Cardiovasc J. 2021 Apr;55(2):73-81. doi: 10.1080/14017431.2020.1852308. Epub 2020 Dec 4.
- Sverre E, Peersen K, Weedon-Fekjaer H, Perk J, Gjertsen E, Husebye E, Gullestad L, Dammen T, Otterstad JE, Munkhaugen J. Preventable clinical and psychosocial factors predicted two out of three recurrent cardiovascular events in a coronary population. BMC Cardiovasc Disord. 2020 Feb 5;20(1):61. doi: 10.1186/s12872-020-01368-6.
- Munkhaugen J, Hjelmesaeth J, Otterstad JE, Helseth R, Sollid ST, Gjertsen E, Gullestad L, Perk J, Moum T, Husebye E, Dammen T. Managing patients with prediabetes and type 2 diabetes after coronary events: individual tailoring needed - a cross-sectional study. BMC Cardiovasc Disord. 2018 Aug 3;18(1):160. doi: 10.1186/s12872-018-0896-z.
- Sverre E, Otterstad JE, Gjertsen E, Gullestad L, Husebye E, Dammen T, Moum T, Munkhaugen J. Medical and sociodemographic factors predict persistent smoking after coronary events. BMC Cardiovasc Disord. 2017 Sep 6;17(1):241. doi: 10.1186/s12872-017-0676-1.
- Sverre E, Peersen K, Husebye E, Gjertsen E, Gullestad L, Moum T, Otterstad JE, Dammen T, Munkhaugen J. Unfavourable risk factor control after coronary events in routine clinical practice. BMC Cardiovasc Disord. 2017 Jan 21;17(1):40. doi: 10.1186/s12872-016-0387-z.
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
- NOR-COR REK ID 2013/1885
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