The Effect of Tongguan Capsule for MicroRNA Profiles in Coronary Heart Disease Patients
31 de julho de 2016 atualizado por: Huizheng Zhu, Guangdong Provincial Hospital of Traditional Chinese Medicine
The Effect of Tongguan Capsule for MicroRNA Profiles Between Qi-Stagnation and Qi-Deficiency in Coronary Heart Disease Patients With Blood Stasis Syndrome Undergoing Percutaneous Coronary Intervention
The purpose of this study is to test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
Visão geral do estudo
Status
Desconhecido
Intervenção / Tratamento
Descrição detalhada
The primary end points is the core of the whole experiment scheme.
miRNAs regulate gene expression posttranscriptionally by degrading messenger RNA (mRNA) targets and by blocking their translation Secondary endpoints will include The adverse cardiac clinical events (MACE) in terms of cardiac death,periprocedural myocardial infarction (MI),spontaneous MI and target vessel revascularization(TVR).
Related parameters of qi and blood are the material basis of blood conversion and objective performance is used to evaluate the effect on Tongguan capsule on patients with blood stagnation, which can be either interpretation theory of qi deficiency and blood stagnation and mutual transformation between qi and blood can find targets through Tongguan capsule on blood .
Routine laboratory tests are used for screening patients basic situation and ensure the safety of the experiment The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with the traditional Chinese medicine syndrome type Approximately 100 patients in Coronary Heart Disease Patients with Blood Stasis Syndrome undergoing percutaneous coronary intervention will be enrolled and randomized to divided into Qi -stagnation and blood stasis, Qi- deficiency and blood stasis, after the PCI surgery, Qi deficiency and blood stasis group were randomly divided into Tongguan capsule group and the control group, and qi stagnation and blood stasis group, too ,giving patients through Tongguan capsule 3 pills three times a day(1.5g/day),
once every three months follow-up, after have been followed up to six months
Tipo de estudo
Intervencional
Inscrição (Antecipado)
100
Estágio
- Fase 4
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
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Guangdong
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GuangZhou, Guangdong, China
- Recrutamento
- Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
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Contato:
- Minzhou Zhang, MD
- Número de telefone: 32808 86-20-81887233
- E-mail: 1542377671@qq.com
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Investigador principal:
- Huizheng Zhu, PhD
-
-
Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
35 anos a 75 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Descrição
Inclusion Criteria:
- In line with the diagnostic criteria for acute coronary syndrome (ACS), coronary angiography confirmed for coronary heart disease (CHD), parallel Percutaneous transluminal coronary angioplasty( PTCA) and/or coronary stent implantation was successful
- Postoperative routine drug treatment
- Traditional Chinese Medicine syndrome differentiation of qi -deficiency and qi -stagnation blood stasis or blood stasis license
- Aged 35 to 75 years old
- Must sign a consent form.
Exclusion Criteria:
- Renal insufficiency, the male serum creatinine > 2.5 mg/dl (> 220 umo/l), women > 2.0 mg/dl (> 175 umo/l)
- With obvious liver disease or Alanine aminotransferase ( ALT)， Aspartate aminotransferase ( AST), 3 times higher than normal ceiling
- Serious cardiac insufficiency (EF < 35%)
- Uncontrolled patients with high blood pressure
- Merger or severe valvular heart disease in acute cerebrovascular disease
- Random blood glucose or greater tendency for 13.7 / L diabetes or glycosylated hemoglobin 9.5% or more
- Patients with severe mental illness
- Patients with malignant tumor or life expectancy in less than three years
- Patients with severe hematopoietic system disease
- Refused to sign a consent form, or estimated compliance is poorer, follow-up possibilities claim;
- Pregnancy or ready to pregnant women, nursing mothers;
- Participated in nearly three months, or is in other clinical subjects . -
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
|
Experimental: Tongguan capsule
Tongguan capsule (0.5 g tid.
for 6 months)
|
eligible participants were randomized to receive Tongguan capsule ( 1.5 g/day for six months immediately after PCI)
|
|
Comparador de Placebo: placebo capsule
same volume/day of placebo capsule (0.5 g tid.
for 6 months)
|
eligible participants were randomized to receive placebo capsule ( 1.5 g/day for six months immediately after PCI)
|
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
miRNAs spectrum
Prazo: six months
|
Test the expression of microRNAs related to the syndromes after the intervention of Tongguan capsule,preliminarily to investigate the mechanism of the effects of Tongguan capsule, and provide the biological foundation of curative effect of Tongguan capsule.
|
six months
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
major adverse cardiac event
Prazo: six months
|
frequency of the reported cardiovascular events (defined as cardiogenic death, stroke, recurrent myocardial infarction, readmission on account of deterioration of congestive heart failure or unstable angina, target vessel revascularization)
|
six months
|
|
Renin predicts cardiovascular homeostasis and ventricular remodeling
Prazo: 6 months
|
renin（ng/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
|
6 months
|
|
Ang II predicts cardiovascular homeostasis and ventricular remodeling
Prazo: 6 months
|
Ang II（pg/ml） predicts cardiovascular homeostasis and blood pressure maintenance and plays an important role in ventricular remodeling
|
6 months
|
|
Serum E
Prazo: 6 months
|
Acute coronary syndrome is caused by atherosclerotic plaque instability and rupture.
The stability of plaque is closely related to inflammation.Serum E (pmol / L) is an important pathway of various immune and inflammatory regulation, which promotes the development of atherosclerosis and is a risk factor for atherosclerosis.
|
6 months
|
|
Inflammatory mediators
Prazo: 6 months
|
Tumor Necrosis factor alpha (ng/L)and Interleukin-6，IL-6 (ng/L) measure of the general situation of patients
|
6 months
|
|
Brain Natriuretic Peptide
Prazo: 6 months
|
B-type natriuretic peptide（pg/ml） is a neurohormone synthesized in the cardiac ventricles upon ventricular pressure overload and ventricular dilatation
|
6 months
|
|
Echocardiography measure of left ventricular systolic function
Prazo: 6 months
|
Evaluation of left ventricular systolic function by left ventricular ejection fraction( LVEF) (%)
|
6 months
|
|
Echocardiography measure of left ventricular diastolic function
Prazo: 6 months
|
Left ventricular end diastolic diameter (LVEDD) (mm )measure of left ventricular diastolic function in patients
|
6 months
|
|
New York Heart Association functional classification
Prazo: 6 months
|
I Cardiac disease, but no symptoms and no limitation in ordinary physical activity, e.g.
no shortness of breath when walking, climbing stairs etc. II Mild symptoms (mild shortness of breath and/or angina) and slight limitation during ordinary activity.
III Marked limitation in activity due to symptoms, even during less-than-ordinary activity, e.g.
walking short distances (20-100 m).Comfortable only at rest.
IV Severe limitations.
Experiences symptoms even while at rest.
Mostly bedbound patients.
|
6 months
|
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Coronary angiography
Prazo: 6 months
|
Quantitative coronary angiography in the stenosis degree, 25%, 50%, 75%, 90%, 99%, 100%, 1, 2, 4, 6, 8,, 16, 32, and, respectively. Scoring multiplication will segment coefficients corresponding to the degree of stenosis and the stenosis of total score that is the sum of Gensini score of coronary artery stenosis in the patients. |
6 months
|
|
Pontuação do Questionário de Angina de Seattle
Prazo: 6 meses
|
O Seattle Angina Questionnaire é um instrumento válido e confiável que mede cinco dimensões clinicamente importantes da saúde em pacientes com doença arterial coronariana (limitação física, estabilidade anginosa, frequência anginosa, satisfação com o tratamento e percepção da doença).
(em unidades em uma escala).
|
6 meses
|
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The traditional Chinese medicine syndrome scale
Prazo: 6 months
|
The traditional Chinese medicine syndrome scale Including the the score of deficiency of qi and score of blood stasis syndrome mainly used to identify patients with traditional Chinese medicine syndrome type
|
6 months
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Diretor de estudo: Minzhou Zhang, MD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
- Investigador principal: Huizheng Zhu, PhD, Department of Critical Care Medicine, Guangdong Provincial Hospital of Chinese Medicine
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo
1 de julho de 2016
Conclusão Primária (Antecipado)
1 de setembro de 2017
Conclusão do estudo (Antecipado)
1 de dezembro de 2017
Datas de inscrição no estudo
Enviado pela primeira vez
21 de julho de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
27 de julho de 2016
Primeira postagem (Estimativa)
1 de agosto de 2016
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
2 de agosto de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
31 de julho de 2016
Última verificação
1 de julho de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- B2015-129-01
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